Fish Collagen Peptide Food Supplement on Weight and Body Composition

Weight Management Clinical Trial

— NATICOL  

Official title:

Effect of a Fish Collagen Peptide Food Supplement on the Weight and Body Composition of Healthy Volunteers in Overweight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03872297
• Other study ID #: 2018-A02490-55
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: July 30, 2019

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• Body Weight
• Food Complement
• Weight Management

Intervention

Dietary Supplement:
• Placebo 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.
• Naticol 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.

Locations

Country	Name	City	State
France	NutrInvest - Institut Pasteur de Lille	Lille	Nord

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	Weight of participants	Weight is expressed in kilograms	0 and 3 months
Secondary	Body composition par DXA analysis	Fat mass is expressed in kg and percent, muscle mass in kg and percent.	0 and 3 months
Secondary	Waist circumference	Data are expressed in centimeters	0 and 3 months
Secondary	Lipid profile in plasma	Total cholesterol, HDL cholesterol, LDL cholesterol, and Triglycerides. Data are expressed in g/L and in mmol/L	0 and 3 months
Secondary	Glycemia level in plasma	Data are expressed in g/L and mmo/L	0 and 3 months
Secondary	Insulin level in plasma	Data are expressed in µU/ml	0 and 3 months
Secondary	HOMA index	This index indicates the insulin resistance and was calculated as follow : HOMA [(glycémie mmol/l X insulinémie µU/ml) à jeun / 22,5]	0 and 3 months
Secondary	Physical activity intensity	Score obtained via Ricci and Gagnon questionnaire. The questionnaire contains 9 questions ; score could be between 9 and 45 points.; under 18 points : inactive behavior; between 19 and 35 points : active behavior; over 35 points : very active behavior	0 and 3 months
Secondary	Pro-inflammatory cytokines concentration	Assay for TNFalpha, IL-1beta and IL-6 in plasma	0 and 3 months
Secondary	Microbiota analysis	Rate comparison of different bacteria families	0 and 3 months
Secondary	Height	centimeters	0
Secondary	Body mass index	kg/m²	0 and 3 months