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

Nektium Pharma SL37 enrolled

Overview

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.

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.

Study Type

Eligibility

Sex: ALLMin age: 40 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Change in Hamilton Anxiety Rating Scale (HAM-A) score

Change in HAM-A score for Vanizem group compared to placebo control group. 14-items questionnaire reflecting 13 categories of anxiety-related symptom to measure anxiety.

Time frame: At baseline (day 0) and after intake period (day 2+)

Secondary Outcomes

Change in Profile of Mood States (POMS) score

Change in POMS score for Vanizem group compared to placebo control group. 65-items to evaluate short-term emotional states and represent six subscales assessing tension-anxiety, depression, anger-hostility, fatigue, confusion-bewilderment, and vigor-activity.

Time frame: At baseline (day 0) and after intake period (day 2+)

Change in Pittsburgh Sleep Quality Index (PSQI) score

Change in PSQI score for Vanizem group compared to placebo control group. 24-items measuring seven dimensions that can be broadly categorized into sleep efficiency factors (sleep quality, sleep latency, sleep duration, and habitual sleep efficiency) and sleep disturbance factors (sleep disturbance, use of sleep medications, and daytime disturbance).

Time frame: At baseline (day 0) and after intake period (day 2+)

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.

Change in LSEQ score for Vanizem group compared to placebo control group.

Time frame: At baseline (day 0) and after intake period (day 1+ and day 2+)

Change in Heart Rate Variability (HRV)

Change HRV score for Vanizem group compared to placebo control group. Heart rate variability measured as interbeat intervals (ms) has been collected with POLAR H10+ heart rate bands during sleeping hours.

Time frame: At baseline (day 0) and after intake period (day 1+ and day 2+)

Change in blood pressure score

Change in systolic and diastolic blood pressure (mmHg) for Vanizem group compared to placebo control group.

Time frame: At baseline (day 0) and after intake period (day 2+)

Change in blood cells count

Changes in a neutrophils, lymphocyte, monocyte, eosinophil, basophil, platelet and red blood cell counts (Cells/mcL) for Vanizem group compared to placebo control group.

Time frame: At baseline (day 0) and after intake period (day 2+)

Change in blood minerals levels

Changes in Magnesium (mmol/L) and Zinc (mcmol/L) levels for Vanizem group compared to placebo control group.

Time frame: At baseline (day 0) and after intake period (day 2+)

Change in blood electrolyte levels

Changes in Sodium and Chloride levels (mEq/L) for Vanizem group compared to placebo control group.

Time frame: At baseline (day 0) and after intake period (day 2+)

Change in serum hepatic enzymes

Changes in gamma-glutamyltransferase (GGT), serum glutamic pyruvic transaminase (GPT), serum glutamic oxaloacetic transaminase (GOT) and alkaline phosphatase (AP) levels (IU/L) for Vanizem group compared to placebo control group.

Time frame: At baseline (day 0) and after intake period (day 2+)

Change proinflammatory serum biomarkers

Changes in interleukin-1, interleukin-6, interleukin-8 and tumour necrosis factor alpha levels (pg/mL) for Vanizem group compared to placebo control group.

Time frame: At baseline (day 0) and after intake period (day 2+)

Change in protein serum biomarker of inflammation

Changes in c-reactive protein levels (mg/L) for Vanizem group compared to placebo control group.

Time frame: At baseline (day 0) and after intake period (day 2+)

Change in serum biomarker of stress

Changes in cortisol (mcg/dL) levels for Vanizem group compared to placebo control group.

Time frame: At baseline (day 0) and after intake period (day 2+)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes