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

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.

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;