Fish Collagen Peptide Food Supplement on Weight and Body Composition

NCT03872297 | Completed DMC

• 1 other identifier: 2018-A02490-55
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Fish collagen hydrolysates or peptides orally administered have been investigated in recent clinical trials in human health. These peptides have been evaluated in various biological and medical fields including skin aging, osteoarticular apparatus, muscle and more recently in energy metabolism in both animals and humans. However, very few studies investigated the effect of fish collagen peptides on weight, body composition or glycemic response. Recently, it has been shown that the consumption of fish collagen peptides (Naticol®) limits weight gain and increase in fat mass in a mouse model made obese by a hyperlipidic diet. Since these results have never been observed in humans, this pilot study proposes to answer this question.

Conditions

Weight Management; Food Complement

Outcome Measures

Primary Outcomes (1)

• Weight of participants

  Weight is expressed in kilograms

  0 and 3 months

Secondary Outcomes (11)

• Body composition par DXA analysis

  0 and 3 months

• Waist circumference

  0 and 3 months

• Lipid profile in plasma

  0 and 3 months

• Glycemia level in plasma

  0 and 3 months

• Insulin level in plasma

  0 and 3 months

Study Arms (2)

Placebo supplement

PLACEBO COMPARATOR

Consumption of a non active food complement during 3 months.

Dietary Supplement: Placebo supplement

Naticol supplement

ACTIVE COMPARATOR

Consumption of the active food complement during 3 months containing Naticol.

Dietary Supplement: Naticol supplement

Interventions

Placebo supplement DIETARY_SUPPLEMENT

Consumption of a non active food complement during 3 months. Tests performed : * 2 blood tests : * 2 body composition analysis via Dual-energy X-ray absorptiometry (DXA) * 2 stool collections The first one of these analysis was performed at the beginning, second at the end of the study.

Placebo supplement

Naticol supplement DIETARY_SUPPLEMENT

Consumption of the active food complement during 3 months containing Naticol. Tests performed : * 2 blood tests : * 2 body composition analysis via Dual-energy X-ray absorptiometry (DXA) * 2 stool collections The first one of these analysis was performed at the beginning, second at the end of the study.

Naticol supplement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: To avoid action of femal hormone, this pilot study is based on male population
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men in overweight (BMI between 25kg/m² and 30kg/m²)
• Aged from 18 and 60 years
• Having signed the informed consent form;
• Susceptible to follow the constraints generated by the study;

You may not qualify if:

• Subject treated for type 1 or 2 diabetes, or for any other metabolic disorder (severe dyslipidemia: TG\> 3 g / L and total cholesterol\> 2.5 g / L);
• Subject with untreated and uncorrected high blood pressure;
• Subject with untreated or uncorrected dysthyroidism by drug therapy;
• Subject with a serious general illness that may prevent his or her ability to complete the trial or that could bias the results of the study;
• Subject treated with steroidal anti-inflammatory drugs, anabolic steroids, anticoagulants or corticosteroids;
• Subject knowing allergy to fish or fish collagen;
• Subject taking any dietary supplement or drug that may interact with the results of the study or that could alter the bioavailability of the product under study;
• Subject having lost more than 5% of his initial weight during the last 3 months;
• Subject following a special diet: eg. vegetarian, macrobiotic diet, high protein diet;
• Subject with diagnosed eating disorders (anorexia, bulimia);
• Subject with gastrointestinal malabsorption such as celiac disease, Crohn's disease or lactose intolerance;
• Subject having undergone bariatric surgery;
• Subject with excessive alcohol consumption at more than 3 drinks a day ;
• Subject planning to modify his tobacco consumption (eg weaning) or his level of physical activity (significant increase) before the end of the intervention period;
• Subject having an aversion to the grapefruit aroma;

Sponsors & Collaborators

• Institut Pasteur de Lille: lead

Study Sites (1)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

Location

Study Officials

• Jean-Michel LECERF, MD

  Institut Pasteur de Lille - NutrInvest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD in nutrion and endocrinology

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: January 14, 2019
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2019
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)