- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05178667
Food Supplement Effect on Overweight or Moderate Obesity (PHYTOENIX)
13 december 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
129
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Paris, Frankrijk, 75013
- Institute of Cardiometabolism And Nutrition
-
-
Nord
-
Lille, Nord, Frankrijk, 59019
- NutrInvest - Institut Pasteur de Lille
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: High dose
4 capsules with 1.6g of active product per day: 2 at breakfast and 2 at dinner
|
Food supplements are consumed during 3 months by healthy volunteers.
|
|
Actieve vergelijker: Low dose
4 capsules with 0.8g of active product per day: 2 at breakfast and 2 at dinner
|
Food supplements are consumed during 3 months by healthy volunteers.
|
|
Placebo-vergelijker: Maltodextrin
4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner
|
Food supplements are consumed during 3 months by healthy volunteers.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline weight at 3 months
Tijdsspanne: 0 month (inclusion), 3 months
|
Weight (unit: kg)
|
0 month (inclusion), 3 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Body mass composition by DEXA (dual energy x-ray absorptiometry)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0 month (inclusion), 3 months
|
Carbohydrate metabolism: Fasting glycemia (unit: g/l)
|
0 month (inclusion), 3 months
|
|
Insulinemia
Tijdsspanne: 0 month (inclusion), 3 months
|
Carbohydrate metabolism: Insulinemia (unit: mU/l)
|
0 month (inclusion), 3 months
|
|
HbA1c
Tijdsspanne: 0 month (inclusion), 3 months
|
Carbohydrate metabolism: HbA1c (unit: percent)
|
0 month (inclusion), 3 months
|
|
HOMA index
Tijdsspanne: 0 month (inclusion), 3 months
|
Carbohydrate metabolism: determination of the HOMA index (calculated)
|
0 month (inclusion), 3 months
|
|
Lipid metabolism
Tijdsspanne: 0 month (inclusion), 3 months
|
Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)
|
0 month (inclusion), 3 months
|
|
Free fatty acids
Tijdsspanne: 0 month (inclusion), 3 months
|
Lipid metabolism: free fatty acids (unit: micromol/l)
|
0 month (inclusion), 3 months
|
|
Hepatic metabolism
Tijdsspanne: 0 month (inclusion), 3 months
|
Creatinine (unit: mg/l)
|
0 month (inclusion), 3 months
|
|
Transaminases
Tijdsspanne: 0 month (inclusion), 3 months
|
Hepatic metabolism: ASAT/ALAT (unit: UI/l)
|
0 month (inclusion), 3 months
|
|
Sedimentation rate
Tijdsspanne: 0 month (inclusion), 3 months
|
Blood parameters: Sedimentation rate (unit: mm)
|
0 month (inclusion), 3 months
|
|
Blood count
Tijdsspanne: 0 month (inclusion), 3 months
|
Blood parameters: Blood count (unit: G/L)
|
0 month (inclusion), 3 months
|
|
Thyroid Stimulating Hormone
Tijdsspanne: 0 month (inclusion), 3 months
|
TSH (Thyroid Stimulating Hormone) (unit: mUI/l)
|
0 month (inclusion), 3 months
|
|
High sensible C-reactive protein
Tijdsspanne: 0 month (inclusion), 3 months
|
CRPhs (high sensible C-reactive protein) (unit: mg/l)
|
0 month (inclusion), 3 months
|
|
Heart rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0 month (inclusion), 1 month, 2 months, 3 months
|
Anthropometric parameters: weight (unit: kg)
|
0 month (inclusion), 1 month, 2 months, 3 months
|
|
Height
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 januari 2022
Primaire voltooiing (Werkelijk)
31 oktober 2022
Studie voltooiing (Werkelijk)
31 oktober 2022
Studieregistratiedata
Eerst ingediend
1 december 2021
Eerst ingediend dat voldeed aan de QC-criteria
16 december 2021
Eerst geplaatst (Werkelijk)
5 januari 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 december 2022
Laatste update ingediend die voldeed aan QC-criteria
13 december 2022
Laatst geverifieerd
1 december 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2021-A02422-39
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .