Food Supplement Effect on Overweight or Moderate Obesity

Obesity Clinical Trial

— PHYTOENIX  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05178667
• Other study ID #: 2021-A02422-39
• Status: Completed
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2022
• Source: Institut Pasteur de Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• High dose
Food supplements are consumed during 3 months by healthy volunteers.
• Low dose
Food supplements are consumed during 3 months by healthy volunteers.
• Maltodextrin
Food supplements are consumed during 3 months by healthy volunteers.

Locations

Country	Name	City	State
France	NutrInvest - Institut Pasteur de Lille	Lille	Nord
France	Institute of Cardiometabolism And Nutrition	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Pasteur de Lille

Country where clinical trial is conducted

France, 

Outcome

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