Food Supplement Effect on Overweight or Moderate Obesity (PHYTOENIX)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: High dose; Dietary supplement: Low dose; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose; 4 capsules with 1.6g of active product per day: 2 at breakfast and 2 at dinner	Dietary supplement: High dose; Food supplements are consumed during 3 months by healthy volunteers.
Active Comparator: Low dose; 4 capsules with 0.8g of active product per day: 2 at breakfast and 2 at dinner	Dietary supplement: Low dose; Food supplements are consumed during 3 months by healthy volunteers.
Placebo Comparator: Maltodextrin; 4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner	Dietary supplement: Maltodextrin; Food supplements are consumed during 3 months by healthy volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline weight at 3 months	Weight (unit: kg)	0 month (inclusion), 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass composition by DEXA (dual energy x-ray absorptiometry)	Lean body mass, total fat mass, subcutaneous fat mass, visceral fat mass (unit: g)	0 month (inclusion), 3 months
Anthropometric parameters	Hip circumference, waist circumference and thigh circumference (unit: cm)	0 month (inclusion), 1 month, 2 months, 3 months
Fasting glycemia	Carbohydrate metabolism: Fasting glycemia (unit: g/l)	0 month (inclusion), 3 months
Insulinemia	Carbohydrate metabolism: Insulinemia (unit: mU/l)	0 month (inclusion), 3 months
HbA1c	Carbohydrate metabolism: HbA1c (unit: percent)	0 month (inclusion), 3 months
HOMA index	Carbohydrate metabolism: determination of the HOMA index (calculated)	0 month (inclusion), 3 months
Lipid metabolism	Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)	0 month (inclusion), 3 months
Free fatty acids	Lipid metabolism: free fatty acids (unit: micromol/l)	0 month (inclusion), 3 months
Hepatic metabolism	Creatinine (unit: mg/l)	0 month (inclusion), 3 months
Transaminases	Hepatic metabolism: ASAT/ALAT (unit: UI/l)	0 month (inclusion), 3 months
Sedimentation rate	Blood parameters: Sedimentation rate (unit: mm)	0 month (inclusion), 3 months
Blood count	Blood parameters: Blood count (unit: G/L)	0 month (inclusion), 3 months
Thyroid Stimulating Hormone	TSH (Thyroid Stimulating Hormone) (unit: mUI/l)	0 month (inclusion), 3 months
High sensible C-reactive protein	CRPhs (high sensible C-reactive protein) (unit: mg/l)	0 month (inclusion), 3 months
Heart rate	Hemodynamic parameters: Heart rate (unit: Pul/min)	0 month (inclusion), 1 month, 2 months, 3 months
Blood pressure	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	Lean body mass and total fat mass (unit: percent)	0 month (inclusion), 1 month, 2 months, 3 months
Weight	Anthropometric parameters: weight (unit: kg)	0 month (inclusion), 1 month, 2 months, 3 months
Height	Anthropometric parameters: height (unit: cm)	0 month (inclusion), 1 month, 2 months, 3 months
Body Mass Index	Anthropometric parameters: determined Body Mass Index (unit: kg/m²)	0 month (inclusion), 1 month, 2 months, 3 months

Collaborators and Investigators

• Sponsor: Institut Pasteur de Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 2021-A02422-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No