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| Name | Class |
|---|---|
| Kinetic performance | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Pill of Food grade Maltodextrin 12 . Once daily for three days. |
|
| Vanizem 50mg | Experimental | Pill of Aframomum melegueta extract 50 mg with Food grade Maltodextrin 12 . Once daily for three days. |
|
| Vanizem 100mg | Experimental | Pill of Aframomum melegueta extract 100 mg with Food grade Maltodextrin 12 . Once daily for three days. |
|
| Vanizem 150mg | Experimental | Pill of Aframomum melegueta extract 150 mg with Food grade Maltodextrin 12 . Once daily for three days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanizem | Dietary Supplement | Aframomum melegueta seed extract standardized to 10% of total Vanilloid and at least 1.5% of 6-paradol |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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+) |
| Measure | Description | Time Frame |
|---|---|---|
| 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+) |
| Measure | Description | Time Frame |
|---|---|---|
| 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+) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura López-Rios, PhD | Nektium Pharma SL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinetic perfomance SL | Alicante | 3005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Umukoro S. and Aladeokin A. C., Therapeutic effects of grains of paradise (aframomum melegueta) seeds Nuts and Seeds in Health and Disease Prevention, 2011, Academic Press, Cambridge, MA, USA, 535-543. | ||
| 25293633 | Background | Ilic NM, Dey M, Poulev AA, Logendra S, Kuhn PE, Raskin I. Anti-inflammatory activity of grains of paradise (Aframomum melegueta Schum) extract. J Agric Food Chem. 2014 Oct 29;62(43):10452-7. doi: 10.1021/jf5026086. Epub 2014 Oct 20. | |
| Background | Ogwu, M.C., Dunkwu-Okafor, A., Omakor, I.A., Izah, S.C. (2024). Medicinal Spice, Aframomum melegueta: An Overview of the Phytochemical Constituents, Nutritional Characteristics, and Ethnomedicinal Values for Sustainability. In: Izah, S.C., Ogwu, M.C., Akram, M. (eds) Herbal Medicine Phytochemistry. Reference Series in Phytochemistry. Springer, Cham. https://doi.org/10.1007/978-3-031-21973-3_72-1 | ||
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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Both the placebo (0 mg) and Botanical extract capsules (50mg, 100mg and 150mg) were identical in appearance to maintain the blindness of the study treatment. Only an unblinded research assistant will have knowledge of which label corresponds to Vanizem doses or placebo. That research assistant will be in charge of: (1) Before each appointment, distributing appropriate treatments or placebo pills into closable pots with a number corresponding to each participant. Care-providers will give closed pots to participants at the time of assessment. (2) Re-labeling all collected data and samples with a participant code number, and sorting into appropriate groups for analysis by blinded researchers.The investigators, study staff, subjects, and statisticians were blinded to the study.
| Placebo | Dietary Supplement | Food grade Maltodextrin 12 |
|
| 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+) |
| 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+) |
| Background |
| Umukoro S, Ashorobi RB. Further studies on the antinociceptive action of aqueous seed extract of Aframomum melegueta. J Ethnopharmacol. 2007 Feb 12;109(3):501-4. doi: 10.1016/j.jep.2006.08.025. Epub 2006 Sep 3. |
| 29138604 | Background | Ford JL, Ildefonso K, Jones ML, Arvinen-Barrow M. Sport-related anxiety: current insights. Open Access J Sports Med. 2017 Oct 27;8:205-212. doi: 10.2147/OAJSM.S125845. eCollection 2017. |
| 29031461 | Background | Halson SL, Juliff LE. Sleep, sport, and the brain. Prog Brain Res. 2017;234:13-31. doi: 10.1016/bs.pbr.2017.06.006. Epub 2017 Jul 17. |
| 28434588 | Background | Patel S, Hill MN, Cheer JF, Wotjak CT, Holmes A. The endocannabinoid system as a target for novel anxiolytic drugs. Neurosci Biobehav Rev. 2017 May;76(Pt A):56-66. doi: 10.1016/j.neubiorev.2016.12.033. |
| 25083569 | Background | Batista LA, Gobira PH, Viana TG, Aguiar DC, Moreira FA. Inhibition of endocannabinoid neuronal uptake and hydrolysis as strategies for developing anxiolytic drugs. Behav Pharmacol. 2014 Sep;25(5-6):425-33. doi: 10.1097/FBP.0000000000000073. |
| D009422 |
| Nervous System Diseases |