NCT03075943

Brown Seaweed Extract on Glycemic Control and Body Weight

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	InSea2	Daily supplement: 2 capsules of InSea2
DIETARY_SUPPLEMENT	Placebo	Daily supplement: 2 capsules of Placebo

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-07-01
• Completion: 2019-12-31
• First posted: 2017-03-09
• Last updated: 2022-08-16

Locations

1 site across 1 country: Canada