Brown Seaweed Extract on Glycemic Control and Body Weight (Algues)

Efficacy of a Brown Seaweed Extract on Glycemic Control and Body Weight in Overweight Pre-diabetic Subjects.

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; PreDiabetes
• Intervention / Treatment: Dietary supplement: InSea2; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 0A6
    • Institute of Nutrition and Functional Foods (INAF), Laval University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Dietary supplement: InSea2; Daily supplement: 2 capsules of InSea2; Other Names: Brown seaweed extract supplement
Placebo Comparator: 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)	Dietary supplement: Placebo; Daily supplement: 2 capsules of Placebo; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood glucose (mmol/L)	glucose in the fasting state and during a 2h-OGTT	at baseline and at the end of the intervention (12 week)
Changes in blood insulin (pmol/L) and C-peptide (pmol/L)	insulin and C-peptide in the fasting state and during a 2h-OGTT	at baseline and at the end of the intervention (12 week)
Changes in anthropometrics	body weight (kg), lean mass (kg) and fat mass (kg)	at baseline and at the end of the intervention (12 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure	Systolic and diastolic blood pressure (mmHg)	at baseline and at the end of the intervention (12 week)
Changes in heart rate	Heart rate (n/min)	at baseline and at the end of the intervention (12 week)
Changes in lipid profile	cholesterol (mmol/L), triglycerides (mmol/L), LDLc (mmol/L), HDLc (mmol/L)	at baseline and at the end of the intervention (12 week)
Changes in hsCRP	HsCRP (mg/L)	at baseline and at the end of the intervention (12 week)
Changes in Il-6	IL-6 (pg/L)	at baseline and at the end of the intervention (12 week)
Changes in marker of oxidative stress	F2-isoprostane (ng/mL)	at baseline and at the end of the intervention (12 week)
Changes in markers of gut barrier integrity	LBP (ng/mL), zonulin (ng/mL)	at baseline and at the end of the intervention (12 week)

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Ministry of Agriculture, Fisheries and Food, Quebec; innoVactiv Inc.
• Investigators: Principal Investigator: Hélène Jacques, PhD, Institue of Nutrition and Functional Food (INAF), Laval University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Body Weight
• Other Study ID Numbers: ALGUES 2016-227