Clinical trial NCT06463145: Study of the Anxiolytic Effects of Aframomum Seed Extract in Elderly People
Official title: Effects of a Plant Extract Modulating the Endocannabinoid System and Its Anxiolytic Capacity on Elderly People in Situations of Stress or Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Situational Anxiety
Keywords: Anxiety
Aframomum melegueta seed
Herbal extract
FAAH inhibitor
Quality sleep
Grains of paradise
Lead sponsor: Nektium Pharma SL
Sponsor class: INDUSTRY
Collaborators: name: Kinetic performance
First posted: 2024-06-17
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this pilot clinical trial is to evaluate if one specific botanical extract from Grains of Paradise works to induce anxiolytic effect in adult people in stress or anxiety situations It will also learn about the extract's positive effects on sleep and mood. The main questions it aims to answer are:

Does botanical extract exert an anxiolytic effect on the participants under stress or anxiety circumstances? Does botanical extract promote positive effects on Mood and nocturnal sleep? Does botanical extract influence body parameters like Blood pressure, inflammatory indicators or stress hormones? Researchers will compare tree doses of botanical extract (50,100 or 150mg) to a placebo (a look-alike substance that contains no herbal product) to see if herbal extract support anxiolytic effect.

Participants will:

Take herbal extract or a placebo daily for 3 days. Visit the clinic two times: at the start of the study (day0) and to the end of the study (Day +2)for checkups and tests.

Keep a diary with questions about their activities, daily foods and physicals perceptions.

Detailed description: The present randomized, double-blind, placebo-controlled crossover trial aims to evaluate the effects of standardized aframomum melegueta seed extract (AME) supplementation on anxiety, mood and sleep quality in healthy men and women experiencing anxious situations. A total of 37 participants were randomly assigned to either AME-first groups or placebo-first group; participants were taken 50, 100 or 150 mg of either AME or matched placebo peels daily for three days. This period is followed by a 1 week washout period at the beginning of which all participants will stop the assigned intervention. After this washout the participants will start their crossover intervention. All Participants were instructed to follow a standardized training program throughout the study, including washout periods to maintain uniformity in physical activity and reduce the effect that exercise can have on stress management. The effects of supplement AME doses compared with a placebo, were evaluated using measures to assess anxiety \[The Hamilton Anxiety Scale (HAM-A)\], mood \[Adapted Profile Mood State (POMS)\], sleep quality \[Sleep Evaluation Questionnaire (LSEQ) and Pittsburgh Sleep Quality Index (PSQI)\]. In addition, some physiological (Blood pressure and heart rate variability), biochemical (minerals, hepatic enzymes and inflammatory biomarkers) and hematological variables (Complete cell count) were determined. Testing was completed at the beginning (Day0) and at the end (Day2) of the supplementation periods with the extract and placebo products to assess acute effects following 3 days of daily use.

Eligibility criteria: Inclusion Criteria:

* Male or female between 40 and 50 year of age;
* Healthy people with moderate anxiety: HAM-A score in a range between 18 and 24;
* Subject able and willing to participate to the study by complying with the protocol procedures as confirmed by his dated and signed informed consent form;

Exclusion Criteria:

* Score greater than 20 points on the Hamilton Depression Rating Scale (HDRS);
* Receiving medical treatment for anxiety, stress or depression;
* Drugs and alcohol dependence;
* Serious personality disorders that may interfere with participation in the study (psychosis, intense suicidal ideation, etc.);
* In the case of women, having the intention of becoming pregnant;
* Epileptic disorders;
* Liver disorders (cirrhosis, hepatitis, etc.);
* Professional athletes or those who frequently engage in extreme physical activities;
* Impossibility of completing the intervention period due to external factors;

Primary outcomes:
measure: Change in Hamilton Anxiety Rating Scale (HAM-A) score
timeFrame: At baseline (day 0) and after intake period (day 2+)
Secondary outcomes:
measure: Change in Profile of Mood States (POMS) score
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Change in Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Change in Leeds Sleep Evaluation Questionnaire (LSEQ) score. 10-items evaluating four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness.
timeFrame: At baseline (day 0) and after intake period (day 1+ and day 2+)
measure: Change in Heart Rate Variability (HRV)
timeFrame: At baseline (day 0) and after intake period (day 1+ and day 2+)
measure: Change in blood pressure score
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Change in blood cells count
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Change in blood minerals levels
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Change in blood electrolyte levels
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Change in serum hepatic enzymes
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Change proinflammatory serum biomarkers
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Change in protein serum biomarker of inflammation
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Change in serum biomarker of stress
timeFrame: At baseline (day 0) and after intake period (day 2+)
Other outcomes:
measure: Changes in body composition
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Changes in body weight
timeFrame: At baseline (day 0) and after intake period (day 2+)
measure: Changes in body mass index (BMI)
timeFrame: At baseline (day 0) and after intake period (day 2+)
Locations:
city: Alicante
country: Spain
facility: Kinetic perfomance SL
Study officials:
affiliation: Nektium Pharma SL
name: Laura López-Rios, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Umukoro S. and Aladeokin A. C., Therapeutic effects of grains of paradise (aframomum melegueta) seeds Nuts and Seeds in Health and Disease Prevention, 2011, Academic Press, Cambridge, MA, USA, 535-543.
citation: Ilic NM, Dey M, Poulev AA, Logendra S, Kuhn PE, Raskin I. Anti-inflammatory activity of grains of paradise (Aframomum melegueta Schum) extract. J Agric Food Chem. 2014 Oct 29;62(43):10452-7. doi: 10.1021/jf5026086. Epub 2014 Oct 20.
citation: Ogwu, M.C., Dunkwu-Okafor, A., Omakor, I.A., Izah, S.C. (2024). Medicinal Spice, Aframomum melegueta: An Overview of the Phytochemical Constituents, Nutritional Characteristics, and Ethnomedicinal Values for Sustainability. In: Izah, S.C., Ogwu, M.C., Akram, M. (eds) Herbal Medicine Phytochemistry. Reference Series in Phytochemistry. Springer, Cham. https://doi.org/10.1007/978-3-031-21973-3_72-1
citation: Umukoro S, Ashorobi RB. Further studies on the antinociceptive action of aqueous seed extract of Aframomum melegueta. J Ethnopharmacol. 2007 Feb 12;109(3):501-4. doi: 10.1016/j.jep.2006.08.025. Epub 2006 Sep 3.
citation: Ford JL, Ildefonso K, Jones ML, Arvinen-Barrow M. Sport-related anxiety: current insights. Open Access J Sports Med. 2017 Oct 27;8:205-212. doi: 10.2147/OAJSM.S125845. eCollection 2017.
citation: Halson SL, Juliff LE. Sleep, sport, and the brain. Prog Brain Res. 2017;234:13-31. doi: 10.1016/bs.pbr.2017.06.006. Epub 2017 Jul 17.
citation: Patel S, Hill MN, Cheer JF, Wotjak CT, Holmes A. The endocannabinoid system as a target for novel anxiolytic drugs. Neurosci Biobehav Rev. 2017 May;76(Pt A):56-66. doi: 10.1016/j.neubiorev.2016.12.033.
citation: Batista LA, Gobira PH, Viana TG, Aguiar DC, Moreira FA. Inhibition of endocannabinoid neuronal uptake and hydrolysis as strategies for developing anxiolytic drugs. Behav Pharmacol. 2014 Sep;25(5-6):425-33. doi: 10.1097/FBP.0000000000000073.