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Ethics statement | This study was conducted in accordance with the Declaration of Helsinki [CONSORT diagram | PMC10074366 | ||
Subject recruitment | The study was registered in ClinicalTrials.gov (reg #: NCT04366544) on 29/04/2020. Subjects for this non-randomized parallel controlled study were recruited from the same participant pool as a previously published study [Demographic data | PMC10074366 | ||
Samyama program – preparatory process | PMC10074366 | |||
Dietary requirements | As part of the Samyama preparatory process (60 days before the program), Samyama participants (meditators) followed a vegan diet with at least 50% raw foods consumed. Additionally, they were requested to avoid dietary intake of garlic, onion, chili, eggplant, | PMC10074366 | ||
Meditation practice requirements | Samyama participants (meditators) were required to take several prerequisite meditation programs before enrolling in Samyama. These included Inner Engineering [ | PMC10074366 | ||
Samyama program – retreat | During the program, meditators were to remain silent for the entire 8-day duration of the program. They took part in all-day meditation sessions with intermittent breaks. The program hall was closed to external influences. No specific instructions or programs were given to the controls. Upon completing the Samyama program, there were no further restrictions on meditators. Meditators were able to return to their previous lifestyle. | PMC10074366 | ||
Stool sampling | STERILE, COLD | Subjects were requested to submit stool samples for 3 time points – 2 months before Samyama (T1), immediately before Samyama (T2), and 3 months following Samyama (T3). Stool samples were collected from meditators and control subjects in sterile fecal collection containers. Upon receiving samples from participants, they were packaged with cold packs and shipped overnight. The samples were then stored at -80 ℃ until samples were analyzed. | PMC10074366 | |
Metabolomics | Metabolomics were performed as described previously [Metabolite data was analyzed by El-MAVEN software package and identified by matching observed m/z signals (± 10 ppm) and chromatographic retention times to those observed from commercial metabolite standards (Sigma-Aldrich) [ | PMC10074366 | ||
Microbiota composition and data analysis | We used 16 s rRNA sequencing to study the participants' microbiome over time. Sequencing data from MiSeq was de-multiplexed and converted to FASTQ format using Illumina's bcl2fastq (RRID:SCR_015058) software. CutAdapt was used for initial quality trimming [ | PMC10074366 | ||
Results | PMC10074366 | |||
Demographic data | ± | There were 265 meditators enrolled in this study, including 139 females and 126 males with an average age of 40.7 ± 10.9 years, and 23 house-hold controls including 10 females and 13 males with an average age of 42 ± 1.41. Participants’ demographic data is summarized in Table | PMC10074366 | |
Microbial diversity | Figure Charts show phylum level relative abundance profile for meditators and controls at 3-time pointsPhylum level relative abundance values for timepoints and typesAlpha diversity plots Beta diversity plots. PCoA was used to visualize the Bray–Curtis similarity for all participants over time | PMC10074366 | ||
Differential abundance analysis | To pinpoint the differences in the microbiota (genus level) we conducted differential abundance analysis over time in participants. We did not find any significantly different taxa in control samples over time (data not shown); hence we focused here on meditators only. Among meditators, Taxa enrichment genus level results for meditators. | PMC10074366 | ||
Short-chain fatty acid levels | We further investigated short chain fatty acid (SCFA) levels in participants over time. While we did not find differences over time in the proportions of SCFAs ascribed to carbohydrate metabolism (butyrate, acetate and propionate), we found that within meditators, branched SCFAs including iso-butyrate (Fig. SCFA showed a significant difference. | PMC10074366 | ||
Other metabolites’ profiling | We also explored the changes in other microbial-derived metabolites over time in the participants (untargeted metabolomics analysis). While we did not find any metabolites to be significantly different in control participants over time, we found 46 metabolites to be significantly different in meditators overtime points. Most of these metabolites decreased in T2 and subsequently increased at T3 (Fig. Metabolomics intensity in log2 units. Heatmap of metabolites that have significantly changed across two timepoints. Most metabolites that show significant change are decreased in T2 | PMC10074366 | ||
Conclusion | This non-randomized controlled longitudinal prospective study is among the first and largest to explore the gut microbiome and metabolome profile after an advanced Samyama meditation program delivered with a vegan diet. First, we observed changes in meditator beta diversity after Samyama. Additionally, after the preparatory phase, there was an increase in branched short-chain fatty acids and changes to other metabolite composition. While the implications of these results are not fully understood, these findings do pave the way for further exploration of the impact of meditation and diet on the gut-brain axis. Further study is warranted to validate current observations, investigate significance and mechanisms of action related to diet, meditation, and microbial composition and function, on psychological processes, including mood. | PMC10074366 | ||
Acknowledgements | The authors appreciate support provided by Isha Institute of Inner Sciences, McMinnville, TN and study volunteers for this prospective research on Samyama participants. | PMC10074366 | ||
Authors’ contributions | RECRUITMENT | MR contributed to manuscript preparation, analysis, and experimental design. RV contributed to manuscript preparation and experimental design. HR contributed to analysis and manuscript preparation. MG and AS contributed to manuscript preparation. DP contributed to design and recruitment. BS and SS contributed to manuscript preparation, experimental design, and overall supervision. The author(s) read and approved the final manuscript. | PMC10074366 | |
Funding | This research was funded by Indiana University, Indianapolis, IN. | PMC10074366 | ||
Availability of data and materials | The data is available in from the United States National Library of Medicine and the National Center for Biotechnology Information. The BioProject is 904395 ( | PMC10074366 | ||
Declarations | PMC10074366 | |||
Ethics approval and consent to participate | This study was conducted in accordance with the Declaration of Helsinki (28). It was reviewed and approved by the Indiana University School of Medicine Internal Review Board (IRB) (#1801728792). Subjects provided electronic informed consent for this study after completing initial electronic surveys. | PMC10074366 | ||
Consent for publication | Not applicable. | PMC10074366 | ||
Competing interests | The authors declare no competing interests. | PMC10074366 | ||
References | PMC10074366 | |||
1. Introduction | ±, RET, muscle contraction | CONTRACTION | Choline plays many important roles, including the synthesis of acetylcholine, and may affect muscle responses to exercise. We previously observed correlations between low choline intake and reduced gains in strength and lean mass following a 12-week resistance exercise training (RET) program for older adults. To further explore these findings, we conducted a randomized controlled trial. Three groups of 50-to-69-year-old healthy adults underwent a 12-week RET program (3x/week, 3 sets, 8–12 reps, 70% of maximum strength (1RM)) and submitted >48 diet logs (>4x/week for 12 weeks). Participants’ diets were supplemented with 0.7 mg/kg lean/d (low, n = 13), 2.8 mg/kg lean/d (med, n = 11), or 7.5 mg/kg lean/d (high, n = 13) of choline from egg yolk and protein powder. The ANCOVA tests showed that low choline intake, compared with med or high choline intakes, resulted in significantly diminished gains in composite strength (leg press + chest press 1RM; low, 19.4 ± 8.2%; med, 46.8 ± 8.9%; high, 47.4 ± 8.1%; Choline plays crucial roles in several physiological processes, such as neurotransmission and muscle contraction via synthesis of the chemical messenger acetylcholine (ACh), lipid transport via lipoprotein synthesis, and methyl-group metabolism as a precursor to betaine [Insufficient choline intake can negatively affect exercises because choline is a precursor to ACh, which mediates muscle contraction and force generation [Previously, we have observed that a lower intake of choline was associated with reduced strength and lean mass gains following 12 weeks of resistance exercise training (RET) in 60-to-69-year-old individuals [Previous studies regarding choline supplementation and exercise generally reported that choline intake exceeding AI, sufficient to increase blood concentrations of choline, does not positively affect exercise performance [The purpose of the present study was to determine the effects of different amounts of choline intakes (approximately 50%, 70%, and 120% of AI) on muscle responses to RET. To maintain consistency with our previous study, we used similar exercise and nutrition control protocols [ | PMC10534351 |
2. Materials and Methods | PMC10534351 | |||
2.1. Participants | RET, cancer, hernia, diabetes, lung disease, hypertension | CARDIAC ARRHYTHMIAS, KIDNEY DISEASE, CANCER, AORTIC ANEURYSM, HYPERTENSION | Thirty-seven generally healthy 50-to-69-year-old males and females were recruited via flyers and advertisements in a local newspaper. Smokers and individuals with any of the following health conditions were excluded: hypertension (>160/100 mmHg), cardiac arrhythmias, cancer, hernia, aortic aneurysm, kidney disease, diabetes, lung disease, and blood cholesterol >240 mg/dL or <160 mg/dL or taking cholesterol-lowering medications. Those who participated in one hour or more of RET per week in the previous year were not eligible for participation, and females needed to be postmenopausal for more than two years. The eligible participants were randomly assigned to one of three choline groups in a double-blind manner: zero additional egg yolk (low), one additional egg yolk (medium = med), or three additional egg yolks (high) per day. This study was conducted in accordance with the Declaration of Helsinki and approved by Texas A&M University Institutional Review Board. All of the participants provided written informed consent prior to participation in the study. All testing, measurement, and RET were performed in the morning hours in an air-conditioned laboratory. All study data were collected over two years during spring, summer, or fall semesters at Texas A&M University by investigators trained in exercise testing and prescription, as well as experimental data collection. | PMC10534351 |
2.2. Orientation | During two weeks of a pre-study orientation period, the participants attended two sessions of nutrition education by a registered dietitian and four sessions of exercise orientation/familiarization ( | PMC10534351 | ||
2.3. Testing | RET | CHOLINE DEFICIENCY | Following the orientation, 1RM, peak power, body composition, resting metabolic rate (RMR), and blood tests were conducted. The 1RMs for all the exercises included in the RET program were measured by gradually increasing exercise weights until the maximum resistance, at which only one repetition was completed with proper form in full range of motion, was reached [Body composition was assessed by dual-energy X-ray absorptiometry (DEXA), using Lunar Prodigy (General Electric, Fairfield, CT, USA), and RMR was measured with ParvoMedics TrueMax 2400 Metabolic Measurement System (Sandy, UT, USA) in the morning after an overnight fast. Fasted (12 h, overnight) blood samples were collected from antecubital veins, and blood lipid/metabolic panels were run with standard methods at St. Joseph Regional Health Center’s CDC certified laboratory (Bryan, TX, USA). The effects of choline intake on clinical markers of liver/muscle damage and blood lipid profile were examined since choline deficiency is shown to cause liver/muscle damage and perturb lipid metabolism [ | PMC10534351 |
2.4. RET | HEART | Based on the recommendations from ACSM and American Heart Association (AHA) [ | PMC10534351 | |
2.5. Nutrition Control | Participants were instructed to consume 50% of total calories from carbohydrates, 30% from fat, 20% from protein, and <10% from saturated fat to meet daily caloric consumption goals, as determined by RMR test. They were also instructed to consume >1.0 g/kg/d of protein, 25–30 g/d of fiber, and <200 mg/d of cholesterol, as recommended by the ADA [To minimize any potential effect that the variability of protein consumption may have [ | PMC10534351 | ||
2.6. Thigh-Muscle Quality | From the DEXA scans of each participant, thigh-muscle quality–strength (TMQ-S) was assessed and defined as leg press 1RM (kg)/total thigh lean mass for both lower limbs (kg). Total thigh lean mass was determined through the construction of a four-sided polygon encompassing the entire region of each thigh and combining lean mass of both thighs together ( | PMC10534351 | ||
2.7. Data Analysis | RET | REGRESSION | All statistical analyses were conducted using SAS/STAT software (version 9.4; SAS Institute Inc., Cary, NC, USA). The mean intakes of all nutrients were calculated from the diet logs that were entered into NutriBase software (version 7, Cybersoft Inc., Phoenix, AZ, USA) or direct calculations from the USDA database for choline [The differences between choline groups were analyzed by one-way ANOVA. The assumption of equal variance was checked using Levene’s test, and the Tukey method was used to perform pairwise comparisons. When the equal variance assumption was not met, Welch’s variance-weighted ANOVA test was performed. ANCOVA tests were conducted to examine the effects of dietary choline, controlling for effects of potential confounders (e.g., cholesterol and other nutrients, sex, age, lean mass, etc.) on RET responses. Multiple linear regression analyses were performed to examine the independent effects of choline consumption and any other factors on RET responses. Composite strength was defined as chest press 1RM + leg press 1RM, and percent change was calculated as 100 × (post-training measurement − pre-training measurement)/pre-training measurement. The | PMC10534351 |
3. Results | PMC10534351 | |||
3.1. Demographics | RET | The baseline characteristics of the 37 participants who completed the 12 weeks of RET are presented in | PMC10534351 | |
3.2. Nutritional Compliance | Participants successfully followed the dietary guidelines of the study and met all the requirements for nutritional intake. On average, the participants consumed 27 kcal/kg/d of energy, 3.2 g/kg/d of carbohydrate, 1.4 g/kg/d of protein, and 1.0 g/kg/d of fat throughout the study, and there was no difference in nutrient intake between choline groups, except for cholesterol consumption (The mean choline consumption was 6.2 ± 1.2 mg/kg lean/d for the low group (~51% of AI), 8.1 ± 1.6 mg/kg lean/d for the med group (~68% of AI), and 14.2 ± 3.0 mg/kg lean/d for the high group (~118% of AI). The choline intake from participants’ own diets was 5.9 ± 2.2 mg/kg lean/d (low = 5.5 ± 1.2 mg/kg lean/d, med = 5.3 ± 1.6 mg/kg lean/d, and high = 6.7 ± 3.0 mg/kg lean/d, | PMC10534351 | ||
3.3. RET Responses | RET | REGRESSION | RET resulted in significant increases in lean mass and strength from baseline in all three groups while only low and med groups lost significant body fat (Because there was no difference between males and females in muscle responses to RET (male vs. female; percent change in lean mass: 3.6 ± 2.0 vs. 3.6 ± 3.6, Because choline consumption was significantly correlated with folate, vitamin BSince RET responses in med and high groups were similar (Multiple linear regression analyses were also conducted to evaluate the independent association of dietary choline and other nutrients, as well as potential confounders. All the variables were initially entered into the regression equation, and the variables were sequentially removed at each step with the backward elimination method. The final model showed that low choline intake independently predicted percent change in composite strength, with betaine intake, male sex, and lean mass remaining in the model (adjusted R | PMC10534351 |
3.4. Blood Lipids and Liver Damage Markers | liver damage, muscle damage | LIVER DAMAGE, CHOLINE DEFICIENCY | Since choline deficiency causes liver/muscle damage and altered lipoprotein/blood lipid metabolism, blood markers for liver damage (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)), muscle damage (creatine kinase (CK)), and blood lipid profiles (triacylglycerol (TAG), total cholesterol, high-density-lipoprotein cholesterol (HDL-C), and low-density-lipoprotein cholesterol (LDL-C)) were also measured. The results showed no effect of choline intake on any of these clinical blood markers ( | PMC10534351 |
4. Discussion | RET | CHOLINE DEFICIENCY, LEAKAGE | The purpose of the present study was to determine the effects of different amounts of choline intakes on muscle responses to RET. We found that low choline intake (~51% of AI) resulted in diminished strength gains with 12 weeks of RET in 50-to-69-year-old individuals, compared to choline intakes of ~68% or ~118% of AI. We also observed that a high choline intake (greater than AI) did not provide additional positive effects on RET responses.It is well known that RET is important for the health and well-being of humans, especially for older individuals [Choline may affect muscle responses to RET through many potential mechanisms. Since choline is a precursor to a neurotransmitter, ACh, which relays a signal from motor neurons to skeletal muscle to contract and generate force, and of which synthesis is reported to be affected by availability of choline [Choline can also influence methylation reactions. A portion of choline is irreversibly converted to betaine, which is used to convert homocysteine to methionine, which is then used to generate Choline is also a precursor to PC, the predominant type of phospholipid in all cell membranes. Therefore, choline contributes to the stability and integrity of cell membranes, and choline deficiency results in weakened cell membranes and the leakage of intracellular enzymes into the circulation. Da Costa et al. [We did not observe any negative effects of low choline consumption on plasma CK concentrations. This may be explained by the difference in the amount of choline intakes between da Costa et al.’s study (<10% of AI) [We also examined the effect of choline intake on blood lipid profiles, since total blood cholesterol and LDL-C were previously reported to be positively associated with lean mass gains [It should be noted that our study results do not necessarily promote high consumption of choline. While the lower (~51% of AI) choline intake resulted in less strength gains, the higher (~118% of AI) choline consumption did not provide any additional training benefits in the present study. Therefore, more emphasis should be placed upon consuming an adequate amount of choline rather than encouraging a higher-than-necessary amount of choline intake. Choline is mainly found in animal-based foods such as eggs and meats, which generally contain high cholesterol [Our study has some limitations, including the inability to determine the mechanisms through which choline may affect RET responses. Since we consistently observed the effects of dietary choline (especially the negative effects of low choline intake [~50% of AI]) on muscle responses to RET, future studies should be focused on elucidating the mechanism(s) of those effects. Moreover, the well-known tendency to under-report food intake associated with diet logs may have obscured the accuracy of our data [ | PMC10534351 |
Author Contributions | T.V.L. | Conceptualization, S.E.R. and C.W.L.; methodology, S.E.R.; validation, T.V.L., E.G., C.W.L. and S.E.R.; formal analysis, C.W.L.; investigation, C.W.L., T.V.L., E.G., V.C.W.C. and S.B.; resources, S.E.R.; data curation, C.W.L. and E.G.; writing—original draft preparation, C.W.L.; writing—review and editing, C.W.L., T.V.L., E.G., V.C.W.C., S.B., S.F.C., J.D.F., S.B.S. and S.E.R.; visualization, C.W.L. and V.C.W.C.; supervision, S.E.R.; project administration, C.W.L. and S.E.R.; funding acquisition, S.E.R. All authors have read and agreed to the published version of the manuscript. | PMC10534351 | |
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Texas A&M University. | PMC10534351 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10534351 | ||
Data Availability Statement | The data presented in this study are available from the authors upon reasonable request. | PMC10534351 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC10534351 | ||
Background | diet-related disease, SSBs | SECONDARY | Pictorial health warnings on sugar-sweetened beverages (SSBs) are a promising policy for preventing diet-related disease in children. A recent study found that pictorial warnings reduced parents’ purchases of SSBs for their children by 17%. However, the psychological mechanisms through which warnings affect parental behavior remain unknown. We aimed to identify the mechanisms that explain how pictorial warnings affect parents’ SSB purchasing behavior for their children using secondary data from a randomized trial. | PMC10290296 |
Methods | In 2020–2021, parents of children ages 2 to 12 years ( | PMC10290296 | ||
Results | SSBs | Two of the 11 constructs were statistically significant mediators. First, the impact of pictorial warnings on the likelihood of purchasing any SSB was mediated by parents’ perceptions that SSBs were healthier for their child (mediated effect= −0.17; 95% CI = − 0.33, − 0.05). Second, parents’ intentions to serve SSBs to their children also mediated the effect of warnings on likelihood of purchasing any SSB (mediated effect= −0.07, 95% CI=-0.21, − 0.003). | PMC10290296 | |
Conclusions | SSBs | Pictorial warnings reduced parents’ purchases of SSBs for their children by making parents think SSBs are less healthful for their children and reducing their intentions to serve SSBs to their children. Communication approaches that target healthfulness perceptions and intentions to serve SSBs may motivate parents to buy fewer SSBs for their children. | PMC10290296 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12966-023-01469-3. | PMC10290296 | ||
Keywords | PMC10290296 | |||
Introduction | obesity, Health behavior, SSBs | OBESITY, DENTAL CARIES | Consumption of sugar-sweetened beverages (SSBs) is associated with numerous health problems in children, including obesity and dental caries [Mounting research indicates that SSB warnings are a promising tool for reducing parents’ selection of SSBs for their children. Three experiments have found that warnings on SSBs reduced parents’ hypothetical selection [Health behavior theories and research suggest several potential mechanisms of SSB warnings’ impact. First, warnings could change behavior by eliciting Two studies have examined how warnings change behavior among adults shopping for themselves, finding that SSB warnings reduced SSB purchasing or selection primarily by heightening message reactions [ | PMC10290296 |
Methods | PMC10290296 | |||
Participants | SECONDARY | The current study used secondary data from a randomized trial with 326 parents of children ages 2–12 years old [To be eligible, participants had to be at least 18 years of age and the parent or guardian (hereafter “parent”) of at least one child ages 2–12 years old who consumed at least one SSB in the past week. Additionally, participants had to be able to read and speak English or Spanish, use a tablet or computer to take a survey, and attend one in-person study visit. The University of North Carolina Institutional Review Board approved the study (IRB #19–0277) and participants provided written informed consent. All study materials were available in English and Spanish. | PMC10290296 | |
Setting | The study took place at the UNC Mini Mart, a 245-square-foot convenience store designed for research purposes, in Chapel Hill, NC [ | PMC10290296 | ||
Procedures | The trial used a parallel arm study design, with staff randomly assigning participants to one of the two trial arms: pictorial warnings or control labels. Staff prepared the Mini Mart before a participant’s arrival based on the assigned trial arm. In the pictorial warnings arm, staff applied one of two warning labels (Fig.
Warning and control labels used in a trial of pictorial health warnings for sugar-sweetened beveragesBefore participants entered the store, staff instructed them to select one snack and one beverage for their child, as well as one household item. This shopping task was designed to mask the purpose of the study. Research staff informed the participants that one of the items would be randomly selected at the checkout counter for the participant to take home. After the shopping task, participants completed a survey programmed in Qualtrics on a computer or tablet in a separate room. Participants received the beverage and cash for a total value of $40 for their participation in the study. | PMC10290296 | ||
Measures | In the current study, we examined mediators of the impact of the pictorial warnings on purchasing any SSBs in the Mini Mart (yes/no), which was the primary outcome for both this study and the main trial [The survey assessed a range of potential psychological mediators using measures adapted or used verbatim from previous studies (Supplementary Table First, the survey assessed three different | PMC10290296 | ||
Analysis | The analytic sample included 325 participants with complete data on the primary outcome in the main trial, excluding one person with missing data on the primary outcome of purchasing any SSB. Mediation analyses used the MacKinnon approach [
Primary mediation modelAnalyses used the PROCESS macro for SPSS (version 4.1) [We planned not to adjust for covariates in based on CONSORT 2010 guidance for RCTs recommending that adjustment is only needed for variables with strong prognostic strength (e.g., stratification variables) [ | PMC10290296 | ||
Association of mediators on purchasing SSBs | When examining the associations between mediators and purchasing any SSBs, controlling for trial arm ( | PMC10290296 | ||
Discussion | SSBs | DISEASE | In this study, we found that pictorial health warnings reduced parents’ purchases of SSBs for their children by reducing the perceived healthfulness of SSBs. Additionally, pictorial warnings changed parents’ purchase behavior by lowering their intentions to serve SSBs to their children, in line with health behavior theories (e.g., the Theory of Planned Behavior) that posit that behavioral intentions predict behavior change [We found that perceived healthfulness of SSBs partially explained how SSB warnings reduced parents’ likelihood of purchasing an SSB for their child. SSB warnings led to lower perceptions that SSBs are healthy for their child, which in turn was associated with a lower likelihood of purchasing of SSBs. Additionally, higher perceived likelihood that SSBs could lead to health problems for their child was associated with a lower likelihood of parents purchasing SSBs (though perceived disease likelihood was not a significant mediator). These findings are in line with a prior study that found that parents’ healthfulness and risk perceptions mediated the impact of health warnings on hypothetical selection of SSBs for their children [In our study, message reactions did not mediate the impact of SSB warnings on parents’ purchases of SSBs. These results stand in contrast to two prior studies with adults, finding that message reactions including emotions and thinking about harms, explained how SSB warnings affected adults’ purchase behaviors and intentions [The differences in mediators between prior studies of adults and the present study of parents suggest that that the process of reacting to health messages might function differently when making purchasing decisions for oneself, compared to when making decisions about another person (perhaps especially when that person is one’s child). One possible explanation for these differences is that message reactions are processes that reflect an individual’s thoughts and feelings, but do not involve considerations for others. Another possibility is that parents are less informed about what beverages are healthy for their children than for themselves, giving warnings more room to changing healthfulness perceptions. Consistent with this hypothesis, prior research shows that parents tend to believe certain types of SSBs including fruit drinks and sports drinks are healthy options for their children [Overall, we found many small effects in our models, which mirrors prior research that health communication interventions often lead to a small (~ 5%) change in a desired outcomes [Strengths of this study include the randomized controlled design. We also assessed an objective purchasing outcome in the context of naturalistic experimental store setting with a wide variety of real products. Limitations include that participants had only one exposure to the warning labels and mediators and outcomes were measured at only one timepoint. Additional studies should establish patterns of mediation over a longer time period and explore serial mediation using longitudinal data. Finally, it is possible that our surveys did not measure all possible mediators of warning labels; future studies including qualitative research could shed light on potential psychological mediators not assessed in this study. | PMC10290296 |
Conclusions | This randomized trial found that pictorial SSB warnings reduced parents’ purchases of SSBs for their children by making parents think SSBs are less healthful for their children and changing parents’ intentions about serving SSBs. These results stand in contrast to prior studies showing that message reactions explain the impact of warnings on adults’ SSB purchases for themselves, and suggest that different mechanisms may underly warning effects for parents purchasing for their children compared to adults purchasing drinks for themselves. Warnings and other communications approaches targeting healthfulness perceptions and intentions may be particularly effective for reducing parents’ purchases of SSBs for their children. | PMC10290296 | ||
Acknowledgements | The authors thank Carmen E. Prestemon and Mirian I. Avendaño-Galdamez for their role in data collection and study coordination. The authors thank the organization El Centro Hispano for their consultation and collaboration on this project. | PMC10290296 | ||
Authors’ contributions | MGH, AHG, AJL, and LST conceptualized the study. MGH, LST, AHG, and AJL acquired funding. ICAH managed the study. TQ analyzed the data. All authors contributed to drafting the manuscript and provided critical feedback on multiple drafts of the paper. | PMC10290296 | ||
Funding | BLOOD, HEART, LUNG, RECRUITMENT | Data collection for the randomized trial was supported by grant #76290 from the Robert Wood Johnson Foundation through its Healthy Eating Research program. General support was provided by NIH grant to the Carolina Population Center, grant numbers P2C HD050924 and T32 HD007168. K01HL147713 from the National Heart, Lung, and Blood Institute of the NIH supported MGH’s time writing the paper. K01HL158608 from the National Heart, Lung, and Blood Institute of the NIH supported AHG’s time writing the paper. F31HD108962 from the National Institute of Child Health and Human Development of the NIH supported APCR’s time writing the paper. We acknowledge recruitment support from the NC Translational and Clinical Sciences (NC TraCS) Institute, which is supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR002489. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. | PMC10290296 | |
Data Availability | The dataset and syntax used in the current study are available from the corresponding author on reasonable request. | PMC10290296 | ||
Declarations | PMC10290296 | |||
Ethics approval and consent to participate | The University of North Carolina’s Institutional Review Board approved this study procedures (study # 19–0277). | PMC10290296 | ||
Consent for publication | Not applicable. | PMC10290296 | ||
Competing interests | None to disclose. | PMC10290296 | ||
Abbreviations | Sugar-sweetened beverage | PMC10290296 | ||
References | PMC10290296 | |||
Abstract | T.-P.S. and C.-T.L. contributed equally. | PMC10229851 | ||
Background | TRD, depressive, treatment-resistant depression, ideation | The benefits of low-dose ketamine for patients with treatment-resistant depression (TRD) and prominent suicidal ideation require further investigation. The effects of treatment refractoriness, the duration of the current depressive episode, and the number of prior antidepressant failures on ketamine efficacy also require clarification. | PMC10229851 | |
Methods | TRD, Depression, depressive, ideation | We recruited 84 outpatients with TRD and prominent suicidal ideation—defined as a score ≥4 on item 10 of the Montgomery–Åsberg Depression Rating Scale (MADRS)—and randomized them into 2 groups to receive 0.5 mg/kg ketamine or 0.045 mg/kg midazolam. We assessed depressive and suicidal symptoms prior to infusion; 240 minutes post infusion; and 2, 3, 5, 7, and 14 days post infusion. | PMC10229851 | |
Results | According to the MADRS scores, the antidepressant effect ( | PMC10229851 | ||
Conclusions | TRD, depressive, ideation | Low-dose ketamine infusion is a safe, tolerable, and effective treatment for patients with TRD and prominent suicidal ideation. Our study highlights the importance of timing; specifically, ketamine is more likely to achieve therapeutic response when the current depressive episode lasted <24 months and the number of failed antidepressants is ≤4. | PMC10229851 | |
Significance Statement | TRD, depressive, ideation | Low-dose ketamine infusion had rapid antidepressant and antisuicidal effects among patients with TRD and prominent suicidal ideation. In addition, the antidepressant effect of ketamine persisted for up to 2 weeks, but the antisuicidal effect lasted only 5 days. Furthermore, timing of ketamine treatment is crucial; specifically, patients with current depressive episodes that have persisted <24 months or ≤4 failed antidepressant treatments may receive the greatest benefits from low-dose ketamine infusion. | PMC10229851 | |
INTRODUCTION | TRD, deaths, depressive, ideation | Over the last half century, worldwide suicide rates have increased by 60%, and suicide accounted for more than 1 million deaths in 2020 (A growing body of evidence has supported the rapid and sustained antisuicidal effect of low-dose ketamine (In a real-world clinical setting, however, TRD and severe suicidal ideation commonly occur together and exacerbate the effects of one another (In the current study, we enrolled 84 patients with TRD and prominent suicidal ideation (MADRS item 10 ≥4) who were randomized to 2 groups receiving a single infusion of either 0.5 mg/kg ketamine or 0.045 mg/kg midazolam. We followed the patients for 2 weeks to assess their depressive and suicidal symptoms. We hypothesized that the low-dose ketamine infusion would exert rapid and sustained antidepressant and antisuicidal effects in patients with TRD and prominent suicidal ideation, particularly among those without severe treatment refractoriness or chronic TRD. | PMC10229851 | |
METHODS | PMC10229851 | |||
Inclusion Criteria and Study Procedure | depressive disorder, ideation | DISORDERS | Adult outpatients aged between 20 and 64 years who were diagnosed with major depressive disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, with inadequate response to at least 2 different antidepressants with adequate dosage and treatment duration and had a prominent suicidal ideation were enrolled in current study. Participants were randomized into 2 groups receiving a single infusion of either 0.5 mg/kg ketamine or 0.045 mg/kg midazolam ( | PMC10229851 |
Statistical Methods | NSI, Suicide Ideation | Continuous variables and nominal variables were analyzed using 1-way ANOVA and Fisher’s chi square tests, respectively, to assess differences between the 2 infusion groups (0.5 mg/kg ketamine or 0.045 mg/kg midazolam) with respect to demographic and clinical data. The generalized estimating equation (GEE) models with the autoregressive method for correlations of repeated measures for the same individual over time and with the adjustment of age, sex, and baseline clinical symptoms were used to assess the trajectories of total MADRS, MADRS item 10, total CSSRS-ISS, and PANSI-Positive Suicide Ideation (PSI) and Negative Suicide Ideation (NSI) scores during the study period with the infusion group (0.5 mg/kg ketamine vs 0.045 mg/kg midazolam) as a between-patient factor and time (baseline, infusion, and follow-up) as a within-patient factor as well as all possible interactions. In addition, we examined the roles of 3 clinical factors, including treatment refractoriness (low and moderate vs high), duration of current episode (<24 vs ≥24 months), and failure numbers of antidepressants (≤4 vs >4), on the trajectories of the above clinical symptoms. Furthermore, owing to the evidence that the duration of the antisuicidal effect of ketamine infusion may not be longer than 1 week ( | PMC10229851 | |
RESULTS | TRD, ideation, posttraumatic stress disorder, treatment-resistant depression, Ideation, PTSD, Suicide Ideation, Depression, Maudsley | REMISSION, POSITIVE | The study flowchart is shown in
Demographic Characteristics, Baseline Clinical Symptoms, and Treatment Outcomes of Patients With TRD and Prominent Suicidal Ideation Receiving a Single Infusion of Ketamine vs Midazolam PlaceboAbbreviations: BMI, body mass index; CSSRS-ISS, Columbia-Suicide Severity Rating Scale-Ideation Severity Subscale; MADRS, Montgomery-Åsberg Depression Rating Scale; MSM, Maudsley Staging Method; NSI, Negative Suicide Ideation; PANSI, Positive and Negative Suicide Ideation Inventory; PSI, Positive Suicide Ideation; PTSD, posttraumatic stress disorder; TRD, treatment-resistant depression.Bold type indicates the statistical significance.
Trajectory of Montgomery-Åsberg Depression Rating Scale (MADRS) scores among patients with treatment-resistant depression (TRD) having prominent suicidal ideation. G, group (ketamine vs midazolam); T, time.More numbers of patients receiving ketamine reached full remission of suicidal ideation based on the total CSSRS-ISS score = 0 from day 2 (n = 14 vs 4, Trajectory of Columbia-Suicide Severity Rating Scale-Ideation Severity Subscale (CSSRS-ISS) and Montgomery-Åsberg Depression Rating Scale (MADRS) item 10 scores among patients with treatment-resistant depression (TRD) having prominent suicidal ideation. G, group (ketamine vs midazolam); T, time. Note: The 2 sets of Trajectory of Columbia-Suicide Severity Rating Scale-Ideation Severity Subscale (CSSRS-ISS) and Montgomery-Åsberg Depression Rating Scale (MADRS) item 10 scores among patients with treatment-resistant depression (TRD) having prominent suicidal ideation, stratified by duration of current episode and failure numbers of antidepressants. G, group (ketamine vs midazolam); T, time. Note: The 2 sets of
Trajectory of Positive and Negative Suicide Ideation Inventory (PANSI) scores among patients with treatment-resistant depression (TRD) having prominent suicidal ideation. G, group (ketamine vs midazolam); NSI, Negative Suicide Ideation; PSI, Positive Suicide Ideation; T, time. Note: The 2 sets of | PMC10229851 |
DISCUSSION | TRD, ideation, tumor necrosis, depressive disorder, depressive, depression | DISEASE, TUMOR NECROSIS | Our results suggest that the antidepressant effect of low-dose ketamine infusion persists for 14 days in patients with TRD and prominent suicidal ideation. However, based on clinician-rated and self-reported measures, the antisuicidal effect of the ketamine infusion may diminish after 5–7 days. Additionally, our study highlights how treatment timing influences the antidepressant and antisuicidal effects of low-dose ketamine; only patients with moderate or low treatment refractoriness, those whose current depressive episode had lasted <24 months, and those with ≤4 failed antidepressant treatments benefited from the low-dose ketamine infusion.Previous studies have investigated the associations between treatment refractoriness and the response to conventional antidepressants, prefrontal theta-burst stimulation (TBS), and electroconvulsive therapy (Treatment refractoriness lies on a clinical spectrum; refractoriness may include the failure of 3 antidepressants to that of all available antidepressants, depressive episodes lasting 6 months to more than 2 years, and response or resistance to neurostimulation (Based on our findings, we propose the following 2 clinical recommendations. First, clinicians should optimize their timing of low-dose ketamine treatment from patients with TRD on the basis of the disease and treatment course. Specifically, patients experiencing depressive episodes that have persisted ≥12 but <24 months or who have failed to respond to >2 but ≤4 antidepressants may benefit the most from ketamine infusion. Second, our previous study suggested that the symptoms of clinical depression can be ameliorated by biweekly ketamine infusion but that the inflammatory profiles of interleukin-2 and tumor necrosis factor-α may be improved more by weekly infusion (Our application of the PANSI-PSI and PANSI-NSI may help to clarify the effect of low-dose ketamine on suicidal symptoms (Finally, the inpatient setting was conducted in previous esketamine or ketamine clinical trials of patients with major depressive disorder and suicidal thoughts (Our study has several limitations. First, we examined ketamine as an add-on medication, meaning that the other medications used by the patients with TRD were not discontinued during the study period. The add-on study design is ethically appropriate for patients with TRD and prominent suicidal ideation and may provide more realistic data. Second, we administered only a single ketamine infusion to each patient. Further studies using repeated infusions of low-dose ketamine are warranted to examine the sustained antidepressant and antisuicidal effects of ketamine in patients with severe depression and suicidal ideation. | PMC10229851 |
CONCLUSIONS | TRD, depressive, ideation | In summary, our study results support the rapid antidepressant and antisuicidal effects of low-dose ketamine infusion on patients with TRD and prominent suicidal ideation. The antidepressant effect of ketamine persisted for up to 2 weeks, but the antisuicidal effect lasted only 5 days. In addition, timing of ketamine treatment is crucial; specifically, patients with moderate or low treatment refractoriness, current depressive episodes that have persisted <24 months, or ≤4 failed antidepressant treatments may receive the greatest benefits from low-dose ketamine infusion. | PMC10229851 | |
Supplementary Material | Click here for additional data file.Click here for additional data file.Click here for additional data file. | PMC10229851 | ||
Acknowledgments | We thank all research assistants, physicians, and pharmacist and nursing staff at D020 Unit of Department of Psychiatry, Taipei Veterans General Hospital and at the Department of Psychiatry, Cheng Hsin General Hospital for their assistance during the study process, without whom this work could not have been possible. We thank Mr I-Fan Hu for his support and friendship.The study was supported by grants from Taipei Veterans General Hospital (V111C-010, V111C-040, V111C-029), Yen Tjing Ling Medical Foundation (CI-109-21, CI-109-22, CI-110-30), Ministry of Science and Technology, Taiwan (MOST110-2314-B-075-026, MOST110-2314-B-075-024-MY3, MOST 109-2314-B-010-050-MY3, MOST111-2314-B-075-014-MY2, MOST 111-2314-B-075-013), Taipei, Taichung, Kaohsiung Veterans General Hospital, Tri-Service General Hospital, Academia Sinica Joint Research Program (VTA112-V1-6-1), and Veterans General Hospitals and University System of Taiwan Joint Research Program (VGHUST112-G1-8-1). The funding source had no role in any process of our study. | PMC10229851 | ||
Author Contributions | W.-C.M. | Drs M.-H.C. and T.-P.S. designed the study. Drs M.-H.C., T.-P.S., W.-C.L., and C.-T.L., and Miss H.-J.W. performed the clinical trials. Dr M.-H.C. analyzed the data and drafted the manuscript. Drs T.-P.S., C.-T.L., W.-C.L., Y.-M.B., S.-J.T., W.-C.M., and P.-C.T. enrolled the candidate patients and performed the literature reviews. Drs L.-F.C. and W.-C.L. performed the literature reviews; all authors reviewed the final manuscript and agreed for the publication. | PMC10229851 | |
Interest Statement | None of the authors in this study had any conflict of interest to declare. | PMC10229851 | ||
References | PMC10229851 | |||
Background | Evidence-based practice (EBP) is the gold standard approach in physiotherapy, and it is essential that students are aware that it is the appropriate way to provide the patient with the best possible treatment. Undergraduate research (UR) can positively influence learning outcomes and research competencies related to EBP compared to traditional methods of higher education. The aim of this study was to evaluate the effect of implementing a research-based activity (i.e., active participation in a randomised controlled trial [RCT]) in the UR programme on the learning and acquisition of research methodology-related competencies by first-year physiotherapy students. | PMC10559614 | ||
Methods | Students in the first academic year of the Bachelor´s Degree in Physiotherapy of University of Deusto (Donostia-San Sebastian, Spain) who were enrolled in the subject ‘Introduction to Research Methodology’ were invited to take part in a real RCT which consisted of three groups: intervention, placebo, and control group. While the RCT was carried out, researchers and/or participants roles were combined among students during the semester. At the end, a questionnaire that included open and closed questions was used to evaluate the effectiveness of the UR strategies used in students´ acquisition of theoretical knowledge, research competencies, self-efficacy of RCT skills and procedures. Lecturers also completed the questionnaire to evaluate their experience. | PMC10559614 | ||
Results | From the 114 students enrolled in the subject, 102 participated in the RCT and 110 answered the final questionnaire. Regarding the development of research competencies, UR had a positive or very positive impact on critical thinking (67% and 18%, respectively) and in the assessment of methodological quality (66% and 23%, respectively). Furthermore, most students reported that the implementation of the RCT facilitated their knowledge of placebo, detection of bias, development of critical thinking and a better understanding of methodological issues in research. Lecturers reported an additional burden that was difficult to reconcile with daily duties. | PMC10559614 | ||
Conclusion | The novel UR program provided students with a new opportunity to improve their knowledge of RCT procedures, thus making the learning process more meaningful. Therefore, ways of teaching and learning focused on improving research and inquiry attitudes should be considered and integrated into the health care curriculum, especially in physiotherapy programs, to ensure the transfer of EBP for the provision of the best care. | PMC10559614 | ||
Trial registration | Australian New Zealand Clinical Registry: ACTRN12622000263796p (14/02/2022). | PMC10559614 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12909-023-04716-0. | PMC10559614 | ||
Keywords | PMC10559614 | |||
Background | The development of research skills at higher education is considered a challenge where the institutions and lecturers try to combine educational and research attitudes, while inexperienced and novice students need to develop scientific skills [EBP consists in the application of the best scientific evidence in clinical decision-making by integrating clinical experience, incorporating patient values and preferences into the practice of professional patient care [However, the term EBP should be clarified since it is considered a general, universal, and gold standard learning outcome for clinical practice rather than a specific education strategy per se (Evidence supports that UR implementation increases motivation and develops an investigative attitude and vital general skills in students [ | PMC10559614 | ||
Methods | BLIND | A real RCT where students could take part as researchers and/or participants as the main UR strategy was undertaken. The aim of the RCT was to evaluate the effectiveness of a superficial neuromodulation device developed by an external private company (© 2020 Irmoki). However, the true aim of the study reported here, to which students taking part were blind, was to evaluate the effect of the implementation of UR (through a teaching and learning strategy that included the design and active participation of students in an RCT) as described earlier.First-year students of the Bachelor’s Degree in Physiotherapy and the Bachelor’s double Degree in Physiotherapy and Physical Activity and Sport Sciences, who were enrolled in the subject ‘Introduction to Research Methodology’ at University of Deusto during the course 2021-22 were invited to participate in the study. The lectures are taught by two lecturers in three different languages (Basque, Spanish, and English). One lecturer was in charge of one group (the Basque group), whereas the other lecturer led the Spanish and English groups. The number of students for both lecturers was very similar, and they were strictly coordinated to teach in parallel, sharing content, teaching methods, schedule, and evaluation system. Indeed, the subject of “Biostatistics” was also shared between both of them. Finally, they can be considered as active researchers (publishing articles, leading projects and attending congresses) in their background of musculoskeletal and respiratory physiotherapy area, respectively.It is worth mentioning that the University of Deusto implemented the Degree in Physiotherapy in the academic year 2020–2021. The emerging academic frame allowed the early integration of UR thanks to a curriculum designed according to guidelines set by experts [For the sake of clarity, two types of procedures have been distinguished: first, those related to RCT procedures, and then those related to UR programme implementation. | PMC10559614 | |
Procedures related to RCT | PMC10559614 | |||
Study design and registration | This RCT was designed following the Consolidated Standard of Reporting Trials for Controlled Studies (CONSORT) statement, registered with the Australian New Zealand Clinical Registry (ACTRN12622000263796p, 14/02/2022) and approved by the Research Ethics Committee of the University of Deusto (ETK-21/21–22). Details about the RCT are presented in Supplementary material A section. | PMC10559614 |
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