- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05178667
Food Supplement Effect on Overweight or Moderate Obesity (PHYTOENIX)
13. Dezember 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
129
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Paris, Frankreich, 75013
- Institute of Cardiometabolism And Nutrition
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Nord
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Lille, Nord, Frankreich, 59019
- NutrInvest - Institut Pasteur de Lille
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
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Aktiver Komparator: 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.
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Placebo-Komparator: 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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change from Baseline weight at 3 months
Zeitfenster: 0 month (inclusion), 3 months
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Weight (unit: kg)
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0 month (inclusion), 3 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Body mass composition by DEXA (dual energy x-ray absorptiometry)
Zeitfenster: 0 month (inclusion), 3 months
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Lean body mass, total fat mass, subcutaneous fat mass, visceral fat mass (unit: g)
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0 month (inclusion), 3 months
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Anthropometric parameters
Zeitfenster: 0 month (inclusion), 1 month, 2 months, 3 months
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Hip circumference, waist circumference and thigh circumference (unit: cm)
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0 month (inclusion), 1 month, 2 months, 3 months
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Fasting glycemia
Zeitfenster: 0 month (inclusion), 3 months
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Carbohydrate metabolism: Fasting glycemia (unit: g/l)
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0 month (inclusion), 3 months
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Insulinemia
Zeitfenster: 0 month (inclusion), 3 months
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Carbohydrate metabolism: Insulinemia (unit: mU/l)
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0 month (inclusion), 3 months
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HbA1c
Zeitfenster: 0 month (inclusion), 3 months
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Carbohydrate metabolism: HbA1c (unit: percent)
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0 month (inclusion), 3 months
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HOMA index
Zeitfenster: 0 month (inclusion), 3 months
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Carbohydrate metabolism: determination of the HOMA index (calculated)
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0 month (inclusion), 3 months
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Lipid metabolism
Zeitfenster: 0 month (inclusion), 3 months
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Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)
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0 month (inclusion), 3 months
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Free fatty acids
Zeitfenster: 0 month (inclusion), 3 months
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Lipid metabolism: free fatty acids (unit: micromol/l)
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0 month (inclusion), 3 months
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Hepatic metabolism
Zeitfenster: 0 month (inclusion), 3 months
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Creatinine (unit: mg/l)
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0 month (inclusion), 3 months
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Transaminases
Zeitfenster: 0 month (inclusion), 3 months
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Hepatic metabolism: ASAT/ALAT (unit: UI/l)
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0 month (inclusion), 3 months
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Sedimentation rate
Zeitfenster: 0 month (inclusion), 3 months
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Blood parameters: Sedimentation rate (unit: mm)
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0 month (inclusion), 3 months
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Blood count
Zeitfenster: 0 month (inclusion), 3 months
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Blood parameters: Blood count (unit: G/L)
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0 month (inclusion), 3 months
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Thyroid Stimulating Hormone
Zeitfenster: 0 month (inclusion), 3 months
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TSH (Thyroid Stimulating Hormone) (unit: mUI/l)
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0 month (inclusion), 3 months
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High sensible C-reactive protein
Zeitfenster: 0 month (inclusion), 3 months
|
CRPhs (high sensible C-reactive protein) (unit: mg/l)
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0 month (inclusion), 3 months
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Heart rate
Zeitfenster: 0 month (inclusion), 1 month, 2 months, 3 months
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Hemodynamic parameters: Heart rate (unit: Pul/min)
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0 month (inclusion), 1 month, 2 months, 3 months
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Blood pressure
Zeitfenster: 0 month (inclusion), 1 month, 2 months, 3 months
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Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)
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0 month (inclusion), 1 month, 2 months, 3 months
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Body mass composition by impedancemetry
Zeitfenster: 0 month (inclusion), 1 month, 2 months, 3 months
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Lean body mass and total fat mass (unit: percent)
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0 month (inclusion), 1 month, 2 months, 3 months
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Weight
Zeitfenster: 0 month (inclusion), 1 month, 2 months, 3 months
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Anthropometric parameters: weight (unit: kg)
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0 month (inclusion), 1 month, 2 months, 3 months
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Height
Zeitfenster: 0 month (inclusion), 1 month, 2 months, 3 months
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Anthropometric parameters: height (unit: cm)
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0 month (inclusion), 1 month, 2 months, 3 months
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Body Mass Index
Zeitfenster: 0 month (inclusion), 1 month, 2 months, 3 months
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Anthropometric parameters: determined Body Mass Index (unit: kg/m²)
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0 month (inclusion), 1 month, 2 months, 3 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
6. Januar 2022
Primärer Abschluss (Tatsächlich)
31. Oktober 2022
Studienabschluss (Tatsächlich)
31. Oktober 2022
Studienanmeldedaten
Zuerst eingereicht
1. Dezember 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. Dezember 2021
Zuerst gepostet (Tatsächlich)
5. Januar 2022
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
16. Dezember 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. Dezember 2022
Zuletzt verifiziert
1. Dezember 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2021-A02422-39
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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