- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05178667
Food Supplement Effect on Overweight or Moderate Obesity (PHYTOENIX)
13 décembre 2022 mis à jour par: Jean-Michel Lecerf, Institut Pasteur de Lille
Effect of Carrot Seed and Rose Hip Extracts on Weight Management in Subjects With Overweight or Moderate Obesity. A Controlled, Randomized and Double-blind Study.
The aim of this study is to assess the effect of a food supplement containing extracts of carrot and rose hip seeds on the weight of volunteers with overweight or moderate obesity.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
129
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Paris, France, 75013
- Institute of Cardiometabolism And Nutrition
-
-
Nord
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Lille, Nord, France, 59019
- NutrInvest - Institut Pasteur de Lille
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- BMI between 25 and 35 kg / m² (limits excluded),
- Having a fat mass (measured by impedance balance in kg) according to the following table:
Men 18-29 years : ≥ 21.2 kg; Men 30-49 years : ≥ 21.6 kg; Men 50-65 years : ≥ 23.8 kg; Women 18-29 years : ≥ 31.4 kg; Women30-49 years : ≥ 31.8 kg; Women 50-65 years : ≥ 33.9 kg.
- Willing to observe dietetic plan in accordance with dietitian evaluation,
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
- Affiliated with a social security scheme.
Exclusion Criteria:
Dyslipidemia or hyperlipidemia:
- Fasting total cholesterol ≥ 3.0 g / L
- Fasting triglycerides> 2.5 g / L
- with heterozygous familial hypercholesterolemia,
- Diabetes treated or not with medication,
- With severe hepatic and / or renal impairment, liver enzyme level (ALT and / or AST) greater than 2.5 times the upper normal limit,
- TSH abnormal or not stable for at least 3 months,
- History of cardiac disease (heart attack, stroke, coronary artery disease) or chronic inflammatory disease in the previous 6 months,
- With cancer or having had cancer in the 3 years preceding the study, with the exception of basal cell cancers of the skin,
- Taking drugs known to have an impact on weight management (corticosteroids, neuroleptics, anti-HIV triple therapy, etc.) in the month preceding inclusion and / or likely to consume them during the test,
- Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study,
- Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression,
- Weight loss treatment in the previous 6 months or having followed a specific treatment promoting weight loss,
- Non stable weight during the last 6 months (>5% change in total weight),
- With metal implant (to allow DEXA measurement),
- Blood donation in the month before the start of the study and during the study,
- 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,
- 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,
- Following a particular diet (vegan),
- Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting),
- Intense sport exercise practice (physical activity more than 4 hours per week) or not willing to maintain their exercise practises stable during the test,
- Smoking more than 5 cigarettes per day, unstable cigarettes consumption, or smoking cessation during 6 months preceding the inclusion or during the test,
- Bariatric surgery or who has a gastroplasty ring,
- Consuming more than 2 (women) or 3 (men) standard drinks of alcoholic beverage daily,
- Consuming illicit drugs,
- Using topical anti-cellulite treatments,
- For woman: Pregnant or planned to become, breastfeeding, with non-effective contraception,
- Known allergy to one of the component of the supplement (carrot and rose hip),
- Suffering from serious illnesses such as cancer, recent myocardial infarction, serious digestive pathologies or others diseases found to be inconsistent with the conduct of the study by the investigator,
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
- Presenting a psychological or linguistic incapability to sign the informed consent,
- Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: High dose
4 capsules with 1.6g of active product per day: 2 at breakfast and 2 at dinner
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Food supplements are consumed during 3 months by healthy volunteers.
|
|
Comparateur actif: Low dose
4 capsules with 0.8g of active product per day: 2 at breakfast and 2 at dinner
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Food supplements are consumed during 3 months by healthy volunteers.
|
|
Comparateur placebo: Maltodextrin
4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner
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Food supplements are consumed during 3 months by healthy volunteers.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline weight at 3 months
Délai: 0 month (inclusion), 3 months
|
Weight (unit: kg)
|
0 month (inclusion), 3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Body mass composition by DEXA (dual energy x-ray absorptiometry)
Délai: 0 month (inclusion), 3 months
|
Lean body mass, total fat mass, subcutaneous fat mass, visceral fat mass (unit: g)
|
0 month (inclusion), 3 months
|
|
Anthropometric parameters
Délai: 0 month (inclusion), 1 month, 2 months, 3 months
|
Hip circumference, waist circumference and thigh circumference (unit: cm)
|
0 month (inclusion), 1 month, 2 months, 3 months
|
|
Fasting glycemia
Délai: 0 month (inclusion), 3 months
|
Carbohydrate metabolism: Fasting glycemia (unit: g/l)
|
0 month (inclusion), 3 months
|
|
Insulinemia
Délai: 0 month (inclusion), 3 months
|
Carbohydrate metabolism: Insulinemia (unit: mU/l)
|
0 month (inclusion), 3 months
|
|
HbA1c
Délai: 0 month (inclusion), 3 months
|
Carbohydrate metabolism: HbA1c (unit: percent)
|
0 month (inclusion), 3 months
|
|
HOMA index
Délai: 0 month (inclusion), 3 months
|
Carbohydrate metabolism: determination of the HOMA index (calculated)
|
0 month (inclusion), 3 months
|
|
Lipid metabolism
Délai: 0 month (inclusion), 3 months
|
Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)
|
0 month (inclusion), 3 months
|
|
Free fatty acids
Délai: 0 month (inclusion), 3 months
|
Lipid metabolism: free fatty acids (unit: micromol/l)
|
0 month (inclusion), 3 months
|
|
Hepatic metabolism
Délai: 0 month (inclusion), 3 months
|
Creatinine (unit: mg/l)
|
0 month (inclusion), 3 months
|
|
Transaminases
Délai: 0 month (inclusion), 3 months
|
Hepatic metabolism: ASAT/ALAT (unit: UI/l)
|
0 month (inclusion), 3 months
|
|
Sedimentation rate
Délai: 0 month (inclusion), 3 months
|
Blood parameters: Sedimentation rate (unit: mm)
|
0 month (inclusion), 3 months
|
|
Blood count
Délai: 0 month (inclusion), 3 months
|
Blood parameters: Blood count (unit: G/L)
|
0 month (inclusion), 3 months
|
|
Thyroid Stimulating Hormone
Délai: 0 month (inclusion), 3 months
|
TSH (Thyroid Stimulating Hormone) (unit: mUI/l)
|
0 month (inclusion), 3 months
|
|
High sensible C-reactive protein
Délai: 0 month (inclusion), 3 months
|
CRPhs (high sensible C-reactive protein) (unit: mg/l)
|
0 month (inclusion), 3 months
|
|
Heart rate
Délai: 0 month (inclusion), 1 month, 2 months, 3 months
|
Hemodynamic parameters: Heart rate (unit: Pul/min)
|
0 month (inclusion), 1 month, 2 months, 3 months
|
|
Blood pressure
Délai: 0 month (inclusion), 1 month, 2 months, 3 months
|
Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)
|
0 month (inclusion), 1 month, 2 months, 3 months
|
|
Body mass composition by impedancemetry
Délai: 0 month (inclusion), 1 month, 2 months, 3 months
|
Lean body mass and total fat mass (unit: percent)
|
0 month (inclusion), 1 month, 2 months, 3 months
|
|
Weight
Délai: 0 month (inclusion), 1 month, 2 months, 3 months
|
Anthropometric parameters: weight (unit: kg)
|
0 month (inclusion), 1 month, 2 months, 3 months
|
|
Height
Délai: 0 month (inclusion), 1 month, 2 months, 3 months
|
Anthropometric parameters: height (unit: cm)
|
0 month (inclusion), 1 month, 2 months, 3 months
|
|
Body Mass Index
Délai: 0 month (inclusion), 1 month, 2 months, 3 months
|
Anthropometric parameters: determined Body Mass Index (unit: kg/m²)
|
0 month (inclusion), 1 month, 2 months, 3 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
6 janvier 2022
Achèvement primaire (Réel)
31 octobre 2022
Achèvement de l'étude (Réel)
31 octobre 2022
Dates d'inscription aux études
Première soumission
1 décembre 2021
Première soumission répondant aux critères de contrôle qualité
16 décembre 2021
Première publication (Réel)
5 janvier 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 décembre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 décembre 2022
Dernière vérification
1 décembre 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021-A02422-39
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .