Clinical trial NCT03872297: Fish Collagen Peptide Food Supplement on Weight and Body Composition
Official title: Effect of a Fish Collagen Peptide Food Supplement on the Weight and Body Composition of Healthy Volunteers in Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Management
Food Complement
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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 consuming antibiotic treatment in the month prior to inclusion;
* 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 following or having followed a low-calorie diet (energy intake \<1500 kcal / day) in the 3 months preceding inclusion and / or likely to undertake this diet during the test;
* 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;
* Subject unable to understand or adhere to the protocol;
* Subject participating in another clinical study or exclusion period from another study;

Primary outcomes:
measure: Weight of participants
timeFrame: 0 and 3 months
Secondary outcomes:
measure: Body composition par DXA analysis
timeFrame: 0 and 3 months
measure: Waist circumference
timeFrame: 0 and 3 months
measure: Lipid profile in plasma
timeFrame: 0 and 3 months
measure: Glycemia level in plasma
timeFrame: 0 and 3 months
measure: Insulin level in plasma
timeFrame: 0 and 3 months
measure: HOMA index
timeFrame: 0 and 3 months
measure: Physical activity intensity
timeFrame: 0 and 3 months
measure: Pro-inflammatory cytokines concentration
timeFrame: 0 and 3 months
measure: Microbiota analysis
timeFrame: 0 and 3 months
measure: Height
timeFrame: 0
measure: Body mass index
timeFrame: 0 and 3 months
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
Study officials:
affiliation: Institut Pasteur de Lille - NutrInvest
name: Jean-Michel LECERF, MD
role: PRINCIPAL_INVESTIGATOR
References: