Brown Seaweed Extract on Glycemic Control and Body Weight

NCT ID: NCT03075943

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-12-31

Brief Summary

The overall goal of this study is to investigate the effects of a daily dietary supplement of brown seaweed (2 capsules of InSea2®) on body weight, glycemic control and insulin secretion in overweight prediabetic men and women in association with a moderate weight loss intervention.

Detailed Description

Diets that produce lower glucose and insulin responses may reduce diabetes and cardiovascular risk. They may also facilitate weight control by promoting satiety, insulin sensitivity and optimal insulin secretion after a meal. Food ingredients may indeed reduce postprandial glucose and insulin response through an inhibition of α-amylase and α-glucosidase activity that may slow down the absorption of carbohydrates. InSea2® is a unique combination of polyphenolic extracts of brown algae (Ascophyllum nodosum and Fucus vesiculosus) which has been shown to inhibit the action of α-amylase and α-glucosidase. Preliminary data in healthy men and women have demonstrated a reducing effect on plasma insulin of a single intake of InSea2® consumed with a high-carbohydrate meal.

The main objective is to evaluate the effects of a daily dietary supplement of 500 mg (2 capsules) of brown algae extract powder (InSea2®) on body weight and blood glucose homeostasis (glucose, insulin, c-peptide) measured in the fasting state and during a 2-hour oral glucose tolerance test (OGTT) in overweight prediabetic men and women.

The secondary objectives are to assess the contribution of a daily consumption of this supplement (InSea2®) on weight loss when associated with a daily caloric restriction of 500 kcal due to individualized nutritional intervention on markers of lipid profile, blood pressure, inflammation, oxidative stress and gut barrier integrity.

The investigators expect that InSea2® lowers body weight and blood glucose homeostasis (glucose, insulin or C-peptide, as marker of insulin secretion, in the fasting state or during a 2-hour oral glucose tolerance test) in association with metabolic and inflammatory markers in the context of moderate weight loss in overweight prediabetic human subjects.

Conditions

PreDiabetes; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

InSea2

2 capsules/day of InSea2 administered 30 min before a meal (breakfast, lunch or diner) combined with weight loss program (individualized nutritional intervention with a daily restriction of 500 kcal)

Group Type: EXPERIMENTAL

InSea2

Intervention Type: DIETARY_SUPPLEMENT

Daily supplement: 2 capsules of InSea2

Placebo

2 capsules/day of Placebo administered 30 min before a meal (breakfast, lunch or diner) combined with weight loss program (individualized nutritional intervention with a daily restriction of 500 kcal)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Daily supplement: 2 capsules of Placebo

Interventions

InSea2

Daily supplement: 2 capsules of InSea2

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Daily supplement: 2 capsules of Placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Brown seaweed extract supplement; Control

Eligibility Criteria

Inclusion Criteria

• overweight (BMI > 25; waist circumference ≥ 80cm for women and ≥ 94 cm for men)
• fasting insulin (≥ 60 pmol/L)
• Impaired fasting glycemia with or without impaired glucose tolerance
• HbA1c between 5.6 and 6.4
• non-smoking
• stable weight in the past 3 months

Exclusion Criteria

• diabetes
• chronic disease (thyroid dysfunction, hepatic or gastrointestinal disorder, uncontrolled hypertension)
• taking drugs that could affect glucose or lipid metabolism or weight and appetite
• taking dietary supplements (protein powders, fish oil, omega-3 or any marine supplements) or natural health products that could affect glucose, lipid, weight or appetite
• major surgery 3 months prior to the study
• pregnancy
• fish, seafood or iodine allergy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Agriculture, Fisheries and Food, Quebec

OTHER_GOV

Sponsor Role: collaborator

innoVactiv Inc.

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Helene Jacques

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hélène Jacques, PhD

Role: PRINCIPAL_INVESTIGATOR

Institue of Nutrition and Functional Food (INAF), Laval University

Locations

Institute of Nutrition and Functional Foods (INAF), Laval University

Québec, , Canada

Countries

Canada

Other Identifiers

ALGUES 2016-227

Identifier Type: -

Identifier Source: org_study_id