An interventional study of Vanizem and Placebo in Situational Anxiety, sponsored by Nektium Pharma SL. Completed at 1 site in Spain. Open to participants aged 40 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Nektium Pharma SL · Not applicable, Interventional, and Treatment
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.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 37 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Nektium Pharma SL is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Pill of Food grade Maltodextrin 12 . Once daily for three days.
Dietary Supplement: Placebo
Pill of Aframomum melegueta extract 50 mg with Food grade Maltodextrin 12 . Once daily for three days.
Dietary Supplement: Vanizem
Pill of Aframomum melegueta extract 100 mg with Food grade Maltodextrin 12 . Once daily for three days.
Dietary Supplement: Vanizem
Pill of Aframomum melegueta extract 150 mg with Food grade Maltodextrin 12 . Once daily for three days.
Dietary Supplement: Vanizem
Aframomum melegueta seed extract standardized to 10% of total Vanilloid and at least 1.5% of 6-paradol
Food grade Maltodextrin 12
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+)
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+)
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).
Time frame: 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.
Time frame: 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).
Time frame: At baseline (day 0) and after intake period (day 2+)
Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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