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Completed

NCT Number: NCT05178667

Food Supplement Effect on Overweight or Moderate Obesity

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NutrInvest - Institut Pasteur de Lille, Lille, Nord, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High dose

Dietary Supplement

Food supplements are consumed during 3 months by healthy volunteers.

Low dose

Dietary Supplement

Food supplements are consumed during 3 months by healthy volunteers.

Maltodextrin

Dietary Supplement

Food supplements are consumed during 3 months by healthy volunteers.

Primary outcomes

  1. Change from Baseline weight at 3 months

    Time frame: 0 month (inclusion), 3 months

    Weight (unit: kg)

Secondary outcomes

  1. Body mass composition by DEXA (dual energy x-ray absorptiometry)

    Time frame: 0 month (inclusion), 3 months

    Lean body mass, total fat mass, subcutaneous fat mass, visceral fat mass (unit: g)

  2. Anthropometric parameters

    Time frame: 0 month (inclusion), 1 month, 2 months, 3 months

    Hip circumference, waist circumference and thigh circumference (unit: cm)

  3. Fasting glycemia

    Time frame: 0 month (inclusion), 3 months

    Carbohydrate metabolism: Fasting glycemia (unit: g/l)

  4. Insulinemia

    Time frame: 0 month (inclusion), 3 months

    Carbohydrate metabolism: Insulinemia (unit: mU/l)

  5. HbA1c

    Time frame: 0 month (inclusion), 3 months

    Carbohydrate metabolism: HbA1c (unit: percent)

  6. HOMA index

    Time frame: 0 month (inclusion), 3 months

    Carbohydrate metabolism: determination of the HOMA index (calculated)

  7. Lipid metabolism

    Time frame: 0 month (inclusion), 3 months

    Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)

  8. Free fatty acids

    Time frame: 0 month (inclusion), 3 months

    Lipid metabolism: free fatty acids (unit: micromol/l)

  9. Hepatic metabolism

    Time frame: 0 month (inclusion), 3 months

    Creatinine (unit: mg/l)

  10. Transaminases

    Time frame: 0 month (inclusion), 3 months

    Hepatic metabolism: ASAT/ALAT (unit: UI/l)

  11. Sedimentation rate

    Time frame: 0 month (inclusion), 3 months

    Blood parameters: Sedimentation rate (unit: mm)

  12. Blood count

    Time frame: 0 month (inclusion), 3 months

    Blood parameters: Blood count (unit: G/L)

  13. Thyroid Stimulating Hormone

    Time frame: 0 month (inclusion), 3 months

    TSH (Thyroid Stimulating Hormone) (unit: mUI/l)

  14. High sensible C-reactive protein

    Time frame: 0 month (inclusion), 3 months

    CRPhs (high sensible C-reactive protein) (unit: mg/l)

  15. Heart rate

    Time frame: 0 month (inclusion), 1 month, 2 months, 3 months

    Hemodynamic parameters: Heart rate (unit: Pul/min)

  16. Blood pressure

    Time frame: 0 month (inclusion), 1 month, 2 months, 3 months

    Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)

  17. Body mass composition by impedancemetry

    Time frame: 0 month (inclusion), 1 month, 2 months, 3 months

    Lean body mass and total fat mass (unit: percent)

  18. Weight

    Time frame: 0 month (inclusion), 1 month, 2 months, 3 months

    Anthropometric parameters: weight (unit: kg)

  19. Height

    Time frame: 0 month (inclusion), 1 month, 2 months, 3 months

    Anthropometric parameters: height (unit: cm)

  20. Body Mass Index

    Time frame: 0 month (inclusion), 1 month, 2 months, 3 months

    Anthropometric parameters: determined Body Mass Index (unit: kg/m²)

Sponsors and collaborators

Lead sponsor

Institut Pasteur de Lille

Other

Registry information

Official study title

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.

Acronym: PHYTOENIX

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2022
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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