NCT06463145

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Nektium Pharma SL · Industry
• Sex: All
• Age: 40 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Situational Anxiety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vanizem	Aframomum melegueta seed extract standardized to 10% of total Vanilloid and at least 1.5% of 6-paradol
DIETARY_SUPPLEMENT	Placebo	Food grade Maltodextrin 12

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-04-12
• Completion: 2023-05-20
• First posted: 2024-06-17
• Last updated: 2024-07-01

Locations

1 site across 1 country: Spain