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

Nektium Pharma

Status: Completed

Conditions: Situational Anxiety

Treatments: Dietary Supplement: Vanizem; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06463145

AME_HCT_2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 40 to 50 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Pill of Food grade Maltodextrin 12 . Once daily for three days.

Treatment:

Dietary Supplement: Placebo

Vanizem 50mg

Experimental group

Description:

Pill of Aframomum melegueta extract 50 mg with Food grade Maltodextrin 12 . Once daily for three days.

Treatment:

Dietary Supplement: Vanizem

Vanizem 100mg

Experimental group

Description:

Pill of Aframomum melegueta extract 100 mg with Food grade Maltodextrin 12 . Once daily for three days.

Treatment:

Dietary Supplement: Vanizem

Vanizem 150mg

Experimental group

Description:

Pill of Aframomum melegueta extract 150 mg with Food grade Maltodextrin 12 . Once daily for three days.

Treatment:

Dietary Supplement: Vanizem