Study of the Anxiolytic Effects of Aframomum Seed Extract in Elderly People

Situational Anxiety Clinical Trial

Official title:

Effects of a Plant Extract Modulating the Endocannabinoid System and Its Anxiolytic Capacity on Elderly People in Situations of Stress or Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06463145
• Other study ID #: AME_HCT_2023
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: May 20, 2023

Study information

• Verified date: June 2024
• Source: Nektium Pharma SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 20, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anxiety Disorders
• Situational Anxiety

Intervention

Dietary Supplement:
• Vanizem
Aframomum melegueta seed extract standardized to 10% of total Vanilloid and at least 1.5% of 6-paradol
• Placebo
Food grade Maltodextrin 12

Locations

Country	Name	City	State
Spain	Kinetic perfomance SL	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Nektium Pharma SL	Kinetic performance

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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

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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in anthropometric variables	Changes in body weight, lean muscle mass, percentage of lean muscle mass, body fat, percentage of body fat and body mass index for Vanizem group compared to placebo control group.	At baseline (day 0) and after intake period (day 2+)
Primary	Change in Hamilton Anxiety Scale (HAM-A) score	Change in HAM-A score for Vanizem group compared to placebo control scores.	At baseline (day 0) and after intake period (day 2+)
Secondary	Change in Profile of Mood States (POMS) score	Change in POMS score for Vanizem group compared to placebo control scores.	At baseline (day 0) and after intake period (day 2+)
Secondary	Change in Pittsburgh Sleep Quality Index (PSQI) score	Change in PSQI score for Vanizem group compared to placebo control scores.	At baseline (day 0) and after intake period (day 2+)
Secondary	Change in Leeds Sleep Evaluation Questionnaire (LSEQ) score	Change in LSEQ score for Vanizem group compared to placebo control scores.	At baseline (day 0) and after intake period (day 1+ and day 2+)
Secondary	Change Heart Rate Variability (HRV) score	Change VFC score for Vanizem group compared to placebo control scores.	At baseline (day 0) and after intake period (day 1+ and day 2+)
Secondary	Changein Blood Pressure Score	Change in Blood Pressure score for Vanizem group compared to placebo control scores.	At baseline (day 0) and after intake period (day 2+)
Secondary	Change in blood biochemistry parameters	Changes in a complet blood cell count, minerals (Na,Cl,Mg and Zn), hepatic enzymes (GGT,GPT,GOT and FA), proinflammatory marker (C-RP, IL-1,IL-6,IL-8 and TNFalpha) and cortisol for Vanizem group compared to placebo control group.	At baseline (day 0) and after intake period (day 2+)