Fish Collagen Peptide Food Supplement on Weight and Body Composition (NATICOL)

• ClinicalTrials.gov Identifier: NCT03872297
• Recruitment Status: Completed
• First Posted: March 13, 2019
• Last Update Posted: July 14, 2020
• Sponsor: Institut Pasteur de Lille
• Information provided by (Responsible Party): Jean-Michel Lecerf, Institut Pasteur de Lille

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Weight Management; Food Complement	Dietary Supplement: Placebo supplement; Dietary Supplement: Naticol supplement	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of a Fish Collagen Peptide Food Supplement on the Weight and Body Composition of Healthy Volunteers in Overweight
• Actual Study Start Date: January 14, 2019
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: July 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo supplement; Consumption of a non active food complement during 3 months.	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.
Active Comparator: Naticol supplement; Consumption of the active food complement during 3 months containing Naticol.	Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures :

1. Weight of participants [ Time Frame: 0 and 3 months ]
   Weight is expressed in kilograms

Secondary Outcome Measures :

1. Body composition par DXA analysis [ Time Frame: 0 and 3 months ]
   Fat mass is expressed in kg and percent, muscle mass in kg and percent.
2. Waist circumference [ Time Frame: 0 and 3 months ]
   Data are expressed in centimeters
3. Lipid profile in plasma [ Time Frame: 0 and 3 months ]
   Total cholesterol, HDL cholesterol, LDL cholesterol, and Triglycerides. Data are expressed in g/L and in mmol/L
4. Glycemia level in plasma [ Time Frame: 0 and 3 months ]
   Data are expressed in g/L and mmo/L
5. Insulin level in plasma [ Time Frame: 0 and 3 months ]
   Data are expressed in μU/ml
6. HOMA index [ Time Frame: 0 and 3 months ]
   This index indicates the insulin resistance and was calculated as follow : HOMA [(glycémie mmol/l X insulinémie μU/ml) à jeun / 22,5]
7. Physical activity intensity [ Time Frame: 0 and 3 months ]

   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
8. Pro-inflammatory cytokines concentration [ Time Frame: 0 and 3 months ]
   Assay for TNFalpha, IL-1beta and IL-6 in plasma
9. Microbiota analysis [ Time Frame: 0 and 3 months ]
   Rate comparison of different bacteria families
10. Height [ Time Frame: 0 ]
    centimeters
11. Body mass index [ Time Frame: 0 and 3 months ]
    kg/m²

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: To avoid action of femal hormone, this pilot study is based on male population
• Accepts Healthy Volunteers: Yes

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;

Contacts and Locations

Locations

France

NutrInvest - Institut Pasteur de Lille

Lille, Nord, France, 59019

Sponsors and Collaborators

Institut Pasteur de Lille

Investigators

• Principal Investigator: Jean-Michel LECERF, MD; Institut Pasteur de Lille - NutrInvest

More Information

• Responsible Party: Jean-Michel Lecerf, MD in nutrion and endocrinology, Institut Pasteur de Lille
• ClinicalTrials.gov Identifier: NCT03872297
• Other Study ID Numbers: 2018-A02490-55
• First Posted: March 13, 2019
• Last Update Posted: July 14, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Body Weight