Clinical trial NCT03075943: Brown Seaweed Extract on Glycemic Control and Body Weight
Official title: Efficacy of a Brown Seaweed Extract on Glycemic Control and Body Weight in Overweight Pre-diabetic Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Insulin Resistance
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Ministry of Agriculture, Fisheries and Food, Quebec
name: innoVactiv Inc.
First posted: 2017-03-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in blood glucose (mmol/L)
timeFrame: at baseline and at the end of the intervention (12 week)
measure: Changes in blood insulin (pmol/L) and C-peptide (pmol/L)
timeFrame: at baseline and at the end of the intervention (12 week)
measure: Changes in anthropometrics
timeFrame: at baseline and at the end of the intervention (12 week)
Secondary outcomes:
measure: Changes in blood pressure
timeFrame: at baseline and at the end of the intervention (12 week)
measure: Changes in heart rate
timeFrame: at baseline and at the end of the intervention (12 week)
measure: Changes in lipid profile
timeFrame: at baseline and at the end of the intervention (12 week)
measure: Changes in hsCRP
timeFrame: at baseline and at the end of the intervention (12 week)
measure: Changes in Il-6
timeFrame: at baseline and at the end of the intervention (12 week)
measure: Changes in marker of oxidative stress
timeFrame: at baseline and at the end of the intervention (12 week)
measure: Changes in markers of gut barrier integrity
timeFrame: at baseline and at the end of the intervention (12 week)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institute of Nutrition and Functional Foods (INAF), Laval University
Study officials:
affiliation: Institue of Nutrition and Functional Food (INAF), Laval University
name: Hélène Jacques, PhD
role: PRINCIPAL_INVESTIGATOR
References: