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Food Supplement Effect on Overweight or Moderate Obesity (PHYTOENIX)

13. desember 2022 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

129

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Paris, Frankrike, 75013
        • Institute of Cardiometabolism And Nutrition
    • Nord
      • Lille, Nord, Frankrike, 59019
        • NutrInvest - Institut Pasteur de Lille

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Aktiv komparator: 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 komparator: Maltodextrin
4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner
Food supplements are consumed during 3 months by healthy volunteers.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline weight at 3 months
Tidsramme: 0 month (inclusion), 3 months
Weight (unit: kg)
0 month (inclusion), 3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Body mass composition by DEXA (dual energy x-ray absorptiometry)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 0 month (inclusion), 3 months
Carbohydrate metabolism: Fasting glycemia (unit: g/l)
0 month (inclusion), 3 months
Insulinemia
Tidsramme: 0 month (inclusion), 3 months
Carbohydrate metabolism: Insulinemia (unit: mU/l)
0 month (inclusion), 3 months
HbA1c
Tidsramme: 0 month (inclusion), 3 months
Carbohydrate metabolism: HbA1c (unit: percent)
0 month (inclusion), 3 months
HOMA index
Tidsramme: 0 month (inclusion), 3 months
Carbohydrate metabolism: determination of the HOMA index (calculated)
0 month (inclusion), 3 months
Lipid metabolism
Tidsramme: 0 month (inclusion), 3 months
Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)
0 month (inclusion), 3 months
Free fatty acids
Tidsramme: 0 month (inclusion), 3 months
Lipid metabolism: free fatty acids (unit: micromol/l)
0 month (inclusion), 3 months
Hepatic metabolism
Tidsramme: 0 month (inclusion), 3 months
Creatinine (unit: mg/l)
0 month (inclusion), 3 months
Transaminases
Tidsramme: 0 month (inclusion), 3 months
Hepatic metabolism: ASAT/ALAT (unit: UI/l)
0 month (inclusion), 3 months
Sedimentation rate
Tidsramme: 0 month (inclusion), 3 months
Blood parameters: Sedimentation rate (unit: mm)
0 month (inclusion), 3 months
Blood count
Tidsramme: 0 month (inclusion), 3 months
Blood parameters: Blood count (unit: G/L)
0 month (inclusion), 3 months
Thyroid Stimulating Hormone
Tidsramme: 0 month (inclusion), 3 months
TSH (Thyroid Stimulating Hormone) (unit: mUI/l)
0 month (inclusion), 3 months
High sensible C-reactive protein
Tidsramme: 0 month (inclusion), 3 months
CRPhs (high sensible C-reactive protein) (unit: mg/l)
0 month (inclusion), 3 months
Heart rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 0 month (inclusion), 1 month, 2 months, 3 months
Anthropometric parameters: weight (unit: kg)
0 month (inclusion), 1 month, 2 months, 3 months
Height
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. januar 2022

Primær fullføring (Faktiske)

31. oktober 2022

Studiet fullført (Faktiske)

31. oktober 2022

Datoer for studieregistrering

Først innsendt

1. desember 2021

Først innsendt som oppfylte QC-kriteriene

16. desember 2021

Først lagt ut (Faktiske)

5. januar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. desember 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. desember 2022

Sist bekreftet

1. desember 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2021-A02422-39

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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