Clinical trial NCT05776329: Dietary Intervention to Reduce Metabolic Endotoxemia
Official title: Randomized Controlled Clinical Trial on the Anti-inflammatory Effect of a Sustainable Dietary Strategy in Adults With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotoxemia
Intestinal Microbiota
Dietary Habits
Clinical Trial
Obesity
Keywords: Metabolic endotoxemia
Lipopolysaccharide binding protein
Dietary inflammatory index
Planetary health diet
Lead sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An interventional randomized controlled clinical trial of parallel design with active control.
Primary purpose: PREVENTION

Brief summary: The goal of this randomized clinical trial is to compare an antiinflammatory and environmentally friendly dietary strategy (AIA-D) designed based on the planetary health diet recommendations translated to the regional context and including nutrients related to antiinflammatory responses with an active control diet based on general healthy diet recommendations (CONV-D) in adults from 18 to 50 years of age with obesity (body mass index ≥30 kg/m2). The main questions it aims to answer are:

* If the intervention with AIA-D will cause a significant decrease at the end of the intervention (six weeks) in lipopolysaccharide-binding protein (LBP) compared to CONV-D.
* If intervention with AIA-D will cause a significant increase at the end of the intervention (six weeks) in the relative abundance of two specific bacteria genera (AM and FP) when compared to CONV-D.

Participants will:

* Sign the informed consent.
* Provide two peripheral blood samples (taken by our trained professionals).
* Provide two samples of feces.
* Allow anthropometric (body weight, height, hip and waist circumferences) blood pressure measurements on two occasions.
* Respond to 24 h dietary recall on two occasions.
* Attend the 1-hour group sessions requested (three for AIA-D and one for CONV-D).
* Follow the dietary recommendations provided.
* Be willing to participate in social media groups to receive information and follow up during the six weeks of the intervention.

Researchers will compare an antiinflammatory and environmentally friendly strategy (AIA-D) with an active control diet (CONV-D) based on general healthy diet recommendations to see if AIA-D decreases metabolic endotoxemia measured through LBP serum levels and increase the relative abundance of AM and FP, compared to CONV-D.

Detailed description: This randomized clinical trial proposes to evaluate an environmentally friendly dietary strategy (AIA-D) designed based on the planetary health diet recommendations translated to the regional context and including nutrients related to anti-inflammatory responses that can decrease metabolic endotoxemia and promote FP and AM growth associated with anti-inflammatory effects and good intestinal health compared to an active control diet (CONV-D) general healthy diet recommendations.

Primary hypothesis: The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity (body mass index ≥30 kg/m2) will cause a significant decrease at the end of the intervention (six weeks) in the levels of lipopolysaccharide-binding protein (metabolic endotoxemia), and significantly increase the relative abundance of AM and FP, when compared to general healthy diet recommendations.

Secondary hypotheses: The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity (body mass index ≥30 kg/m2) will cause a significant increase at the end of the intervention (six weeks) in the relative abundance of Prevotella, when compared to general healthy diet recommendations.

The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity (body mass index ≥30 kg/m2) will cause a significant decrease at the end of the intervention (six weeks) of body weight, percentage of body fat, body mass index, circumferences of waist and hip when compared to general healthy diet recommendations.

The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity (body mass index ≥30 kg/m2) will improve blood pressure more than the general healthy diet recommendations.

Eligibility criteria: Inclusion Criteria:

* Obesity according to body mass index: ≥ 30 kg/m2
* Willingness to participate and sign the consent form.
* Willingness to follow the dietary recommendations of the protocol.
* Have access to the internet and an electronic device.

Exclusion Criteria:

* Clinically diagnosed with hyperglycemia, hypertension, cardiovascular disease, renal disease, hepatic disease, immunosuppression, or another metabolic disease.
* Being under a dietary restriction regimen or pharmacological treatment to lose weight.
* Consuming dietary supplements for at least six months (vitamins, fatty acids, probiotics, prebiotics).
* Being under treatment with antibiotics or anti-inflammatory drugs in the last three months.
* Having bariatric surgery.
* Being pregnant or lactating.
* Present gastrointestinal disease
* Present Coronavirus disease (COVID-19) symptoms
* Develop diseases that affect body weight
* Becoming pregnant
* Withdrawal of informed consent.

Primary outcomes:
measure: Change in Lipopolysaccharide-binding protein (LBP).
timeFrame: Baseline to six weeks
measure: Change in relative abundance of FP
timeFrame: Baseline to six weeks
measure: Change in relative abundance of AM
timeFrame: Baseline to six weeks
Secondary outcomes:
measure: Change in abundance of Prevotella
timeFrame: Baseline to six weeks
measure: Change in body weight
timeFrame: Baseline to six weeks
measure: Change in body mass index
timeFrame: Baseline to six weeks
measure: Change in hip circumference
timeFrame: Baseline to six weeks
measure: Change in waist circumference
timeFrame: Baseline to six weeks
measure: Change in waist-to-hip ratio
timeFrame: Baseline to six weeks
measure: Change in percentage of body fat
timeFrame: Baseline to six weeks
measure: Change in the dietary inflammatory index.
timeFrame: Baseline to six weeks
measure: Change in blood pressure
timeFrame: Baseline to six weeks
measure: Retention
timeFrame: Baseline to six weeks
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Universidad Vizcaya de las Américas
state: Sonora
city: Hermosillo
country: Mexico
facility: Centro de Investigación en Alimentación y Desarrollo
state: Sonora
Study officials:
affiliation: Centro de Investigación en Alimentación y Desarrollo
name: Silvia Y Moya-Camarena, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halmos EP, Christophersen CT, Bird AR, Shepherd SJ, Gibson PR, Muir JG. Diets that differ in their FODMAP content alter the colonic luminal microenvironment. Gut. 2015 Jan;64(1):93-100. doi: 10.1136/gutjnl-2014-307264. Epub 2014 Jul 12.
citation: Gray L, Hasebe K, O'Hely M, Ponsonby AL, Vuillermin P, Collier F; BIS Investigator Group. Rapid PCR identification of Prevotella copri in an Australian cohort of pregnant women. J Dev Orig Health Dis. 2020 Jun;11(3):228-234. doi: 10.1017/S2040174419000849. Epub 2019 Dec 17.
citation: Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14.
citation: Hebert JR, Shivappa N, Wirth MD, Hussey JR, Hurley TG. Perspective: The Dietary Inflammatory Index (DII)-Lessons Learned, Improvements Made, and Future Directions. Adv Nutr. 2019 Mar 1;10(2):185-195. doi: 10.1093/advances/nmy071.
citation: Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available.