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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
56
Institute of Nutrition and Functional Foods (INAF), Laval University
Québec, Canada
Changes in blood glucose (mmol/L)
glucose in the fasting state and during a 2h-OGTT
Time frame: 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
Time frame: at baseline and at the end of the intervention (12 week)
Changes in anthropometrics
body weight (kg), lean mass (kg) and fat mass (kg)
Time frame: at baseline and at the end of the intervention (12 week)
Changes in blood pressure
Systolic and diastolic blood pressure (mmHg)
Time frame: at baseline and at the end of the intervention (12 week)
Changes in heart rate
Heart rate (n/min)
Time frame: 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)
Time frame: at baseline and at the end of the intervention (12 week)
Changes in hsCRP
HsCRP (mg/L)
Time frame: at baseline and at the end of the intervention (12 week)
Changes in Il-6
IL-6 (pg/L)
Time frame: at baseline and at the end of the intervention (12 week)
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Changes in marker of oxidative stress
F2-isoprostane (ng/mL)
Time frame: at baseline and at the end of the intervention (12 week)
Changes in markers of gut barrier integrity
LBP (ng/mL), zonulin (ng/mL)
Time frame: at baseline and at the end of the intervention (12 week)