Supplément de Moringa pour la gestion du poids chez les personnes en surpoids et obèses
Cette étude interventionnelle évalue l'utilisation du supplément de Moringa pour la gestion du poids chez les personnes en surpoids et obèses. La mesure principale est le changement de poids corporel.
ACV Moringa Effervescent Tablets 4.3 g
+ Placebo Effervescent Tablets 4.3 g
Poids Corporel+5
+ Maladies nutritionnelles et métaboliques
+ Obésité
Étude thérapeutique
Résumé
Date de début de l'étude : 24 juillet 2025
Date à laquelle le premier participant a commencé l'étude.Cet essai clinique est conçu pour examiner comment la prise d'ACV Moringa affecte le changement de poids chez les personnes en surpoids ou atteintes d'obésité de classe I. L'étude implique 66 participants, hommes et femmes âgés de 18 à 65 ans, qui répondent à ces critères. Cette recherche est importante car elle explore une nouvelle méthode potentielle pour aider à gérer le poids, une préoccupation de santé courante avec de nombreux risques associés. En comprenant les effets de l'ACV Moringa, il pourrait y avoir de nouvelles perspectives sur les stratégies efficaces de gestion du poids pour ceux touchés par l'obésité. Les participants seront divisés au hasard en deux groupes, recevant soit le traitement, soit un placebo, de manière aveugle, ce qui signifie que ni les participants ni les chercheurs ne savent qui reçoit le traitement réel pendant l'étude. L'étude durera environ 90 jours avec plusieurs visites, y compris des évaluations de base, des évaluations de suivi et une évaluation finale. Les participants recevront également des rappels quotidiens pour adhérer aux routines alimentaires et d'exercice, ainsi que des vérifications hebdomadaires via une application mobile. Divers paramètres de santé tels que la composition corporelle, l'endurance athlétique et les marqueurs métaboliques seront mesurés pour évaluer l'impact du traitement. Les bénéfices potentiels incluent une meilleure gestion du poids, tandis que les risques seront surveillés tout au long de l'étude.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.66 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: 1. Age: 18- 65 years (both inclusive) at the time of consent. 2. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females). 3. Females of childbearing potential must have a self-reported negative urine pregnancy. 4. Female of childbearing potential must have a reported negative pregnancy during screening and the end of the study 5. Subject is in good general health as determined by the Investigator on the basis of medical history. 6. Subjects who are classified as overweight (BMI 25.0-29.9 kg/m²) or as having Class I obesity (BMI 30.0-34.9 kg/m²). 7. Subjects with a total body fat percentage exceeding 25% for men and 30% for women using Bioimpedance test. 8. Subject is willing to forgo liposuction procedures or any weight loss therapy 3 months prior to and for the duration of the study. 9. Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. 10. If the female subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. 11. If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study. 12. Subject who agree to consume a vegetarian/non-vegetarian diet of approximately 2000 kcal/day (14% protein, 25%Fat and 61% carbohydrate). 13. Subjects willing to follow the given diet and maintain their physical activity by a Diet and physical activity diary. 14. Subjects must possess an Android smartphone to facilitate daily app login and study-related activities. 15. Subjects are willing to give written informed consent and are willing to follow the study procedure. 16. Subjects who commit not to use any other medication for weight management other than the test treatment for the entire duration of the study. 17. Willing to use test treatment throughout the study period. 18. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits. Exclusion Criteria: 1. Subjects BMI is between less than 25 and greater than 35 kg/m2. 2. Subjects having past or present history or clinically significant findings indicating cardiovascular disease, type 2 diabetes mellitus, hypertension, endocrine, pulmonary, neurological or psychological disorders, hypo or hyperthyroidism and renal disorders. 3. Subjects with a history of gastrointestinal disorders, including chronic gastritis, gastric discomfort, or any diagnosed gastrointestinal conditions. 4. Subjects having drug and alcohol abuse. 5. Smokers and tobacco users. 6. Subjects having more than 5 kg variation in body weight within 3 months before study entry. 7. Subjects using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss. 8. Undergone surgery before 30 days of screening or planning to undergo surgery within the study period. 9. Subjects having chronic diarrhoeal disorders, cancer, hepatic dysfunction, and human immunodeficiency virus (HIV) infection. 10. Participation in other drugs, investigational medicinal product, any herbal products and/or cosmetics intended to weight loss clinical trials within 3 months before enrolment in this trial. 11. Any other diseases/co-morbidity that is considered by the Investigator as an exclusion. 12. With severe hepatic and/or renal impairment, liver enzyme level (ALT and/or AST) is greater than 2.5 times the upper normal limit. 13. Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study, 14. Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression. 15. Non-stable weight during the last 6 months (\>5% change in total weight) 16. Consuming food supplements or functional foods known to have an influence on weight management in the month preceding the inclusion and/or likely to take during the test 17. Following or having followed a hypocaloric diet (energy intake \<1,500 kCal/day) in the month preceding inclusion and/or likely to undertake this diet during the test. 18. Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting), 19. Using topical anti-cellulite treatments. 20. Pregnant or breastfeeding or planning to become pregnant during the study period. 21. Subject has a history of chronic illness which may influence the cutaneous state. 22. Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks. 23. Any other condition which could warrant exclusion from the study, as per the Investigator's discretion.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
PlaceboGroupe II
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires