An interventional study of InSea2 and Placebo in PreDiabetes and Insulin Resistance, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-16.
Sponsored by Laval University · Not applicable, Interventional, and Prevention
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.
1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.
This study's enrollment of 56 is below the median of 66 across 861 interventional studies indexed under Prediabetic State.
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Exclusion Criteria:
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
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 InSea2
Also known as: Brown seaweed extract supplement
Daily supplement: 2 capsules of Placebo
Also known as: Control
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)
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)
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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