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

Primary Purpose

Weight Management, Food Complement

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Placebo supplement

Naticol supplement

About this trial

This is an interventional treatment trial for Weight Management

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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;

Sites / Locations

NutrInvest - Institut Pasteur de Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo supplement

Naticol supplement

Arm Description

Consumption of a non active food complement during 3 months.

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

Outcomes

Primary Outcome Measures

Weight of participants

Weight is expressed in kilograms

Secondary Outcome Measures

Body composition par DXA analysis

Fat mass is expressed in kg and percent, muscle mass in kg and percent.

Waist circumference

Data are expressed in centimeters

Lipid profile in plasma

Total cholesterol, HDL cholesterol, LDL cholesterol, and Triglycerides. Data are expressed in g/L and in mmol/L

Glycemia level in plasma

Data are expressed in g/L and mmo/L

Insulin level in plasma

Data are expressed in μU/ml

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]

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

Pro-inflammatory cytokines concentration

Assay for TNFalpha, IL-1beta and IL-6 in plasma

Microbiota analysis

Rate comparison of different bacteria families

Height

centimeters

Body mass index

kg/m²

Full Information

NCT ID

NCT03872297

First Posted

March 11, 2019

Last Updated

December 6, 2022

Sponsor

Institut Pasteur de Lille

1. Study Identification

Unique Protocol Identification Number

NCT03872297

Brief Title

Fish Collagen Peptide Food Supplement on Weight and Body Composition

Acronym

NATICOL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

January 14, 2019 (Actual)

Primary Completion Date

June 30, 2019 (Actual)

Study Completion Date

July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institut Pasteur de Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Management, Food Complement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo supplement

Arm Type

Placebo Comparator

Arm Description

Consumption of a non active food complement during 3 months.

Arm Title

Naticol supplement

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo supplement

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Naticol supplement

Intervention Description

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.

Primary Outcome Measure Information:

Title

Weight of participants

Description

Weight is expressed in kilograms

Time Frame

0 and 3 months

Secondary Outcome Measure Information:

Title

Body composition par DXA analysis

Description

Fat mass is expressed in kg and percent, muscle mass in kg and percent.

Time Frame

0 and 3 months

Title

Waist circumference

Description

Data are expressed in centimeters

Time Frame

0 and 3 months

Title

Lipid profile in plasma

Description

Total cholesterol, HDL cholesterol, LDL cholesterol, and Triglycerides. Data are expressed in g/L and in mmol/L

Time Frame

0 and 3 months

Title

Glycemia level in plasma

Description

Data are expressed in g/L and mmo/L

Time Frame

0 and 3 months

Title

Insulin level in plasma

Description

Data are expressed in μU/ml

Time Frame

0 and 3 months

Title

HOMA index

Description

This index indicates the insulin resistance and was calculated as follow : HOMA [(glycémie mmol/l X insulinémie μU/ml) à jeun / 22,5]

Time Frame

0 and 3 months

Title

Physical activity intensity

Description

Time Frame

0 and 3 months

Title

Pro-inflammatory cytokines concentration

Description

Assay for TNFalpha, IL-1beta and IL-6 in plasma

Time Frame

0 and 3 months

Title

Microbiota analysis

Description

Rate comparison of different bacteria families

Time Frame

0 and 3 months

Title

Height

Description

centimeters

Time Frame

Title

Body mass index

Description

kg/m²

Time Frame

0 and 3 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

To avoid action of femal hormone, this pilot study is based on male population

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Michel LECERF, MD

Organizational Affiliation

Institut Pasteur de Lille - NutrInvest

Official's Role

Principal Investigator

Facility Information:

Facility Name

NutrInvest - Institut Pasteur de Lille

City

Lille

State/Province

Nord

ZIP/Postal Code

59019

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Fish Collagen Peptide Food Supplement on Weight and Body Composition

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