Food Supplement Effect on Overweight or Moderate Obesity

NCT05178667 | Completed

• 1 other identifier: 2021-A02422-39
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change from Baseline weight at 3 months

  Weight (unit: kg)

  0 month (inclusion), 3 months

Secondary Outcomes (20)

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

  0 month (inclusion), 3 months

• Anthropometric parameters

  0 month (inclusion), 1 month, 2 months, 3 months

• Fasting glycemia

  0 month (inclusion), 3 months

• Insulinemia

  0 month (inclusion), 3 months

• HbA1c

  0 month (inclusion), 3 months

Study Arms (3)

High dose

EXPERIMENTAL

4 capsules with 1.6g of active product per day: 2 at breakfast and 2 at dinner

Dietary Supplement: High dose

Low dose

ACTIVE COMPARATOR

4 capsules with 0.8g of active product per day: 2 at breakfast and 2 at dinner

Dietary Supplement: Low dose

Maltodextrin

PLACEBO COMPARATOR

4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner

Dietary Supplement: Maltodextrin

Interventions

High dose DIETARY_SUPPLEMENT

Food supplements are consumed during 3 months by healthy volunteers.

High dose

Low dose DIETARY_SUPPLEMENT

Food supplements are consumed during 3 months by healthy volunteers.

Low dose

Maltodextrin DIETARY_SUPPLEMENT

Food supplements are consumed during 3 months by healthy volunteers.

Maltodextrin

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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,

Sponsors & Collaborators

• Institut Pasteur de Lille: lead

Study Sites (2)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

Location

Institute of Cardiometabolism And Nutrition

Paris, 75013, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Contraceptives, Oral; maltodextrin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Jean-Michel Lecerf, MD

  Institut Pasteur de Lille - NutrInvest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 5, 2022
• Study Start: January 6, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

FR (2)