Study of the Anxiolytic Effects of Aframomum Seed Extract in Elderly People
NCT Number: NCT06463145
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Situational Anxiety
Interventions: DIETARY_SUPPLEMENT: Vanizem|DIETARY_SUPPLEMENT: Placebo
Sponsor: Nektium Pharma SL
Collaborators: Kinetic performance
Sex: ALL
Age: ADULT
Enrollment: 37
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-01
Completion Date: 2023-05-20
Locations: Kinetic perfomance SL, Alicante, 3005, Spain

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.

Primary Outcome Measures: 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., At baseline (day 0) and after intake period (day 2+)
Secondary Outcome Measures: 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., 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)., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., At baseline (day 0) and after intake period (day 2+)
Other Outcome Measures: Changes in body composition, Changes in body fat mass (BFM), body fat percentage (%BF), lean muscle mass (LMM) and percentage of lean muscle mass (%LMM) for Vanizem group compared to placebo control group. Measurements will be assessed using multifrequency bioelectrical impedance analysis (BIA)., At baseline (day 0) and after intake period (day 2+)|Changes in body weight, Changes in body weight (kg) for Vanizem group compared to placebo control group., At baseline (day 0) and after intake period (day 2+)|Changes in body mass index (BMI), BMI for Vanizem group compared to placebo control group. Weight (kg) and height (cm) will be combined to report BMI in (kg/cm\^2)., At baseline (day 0) and after intake period (day 2+)