Brown Seaweed Extract on Glycemic Control and Body Weight (Algues)
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|ClinicalTrials.gov Identifier: NCT03075943|
Recruitment Status : Active, not recruiting
First Posted : March 9, 2017
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|PreDiabetes Insulin Resistance||Dietary Supplement: InSea2 Dietary Supplement: Placebo||Not Applicable|
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 blood glucose measured 2 hours after an oral glucose tolerance test (OGTT) in overweight insulin-resistant 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. More specifically, the investigators aim to evaluate the effects of supplementation combined with weight loss on other markers of glucose metabolism (fasting plasma glucose, glucose and insulin response during OGTT, insulin sensitivity measurement parameters and insulin secretion during OGTT), lipid profile, blood pressure and metabolic syndrome criteria.
The investigators expect that InSea2® lowers the high levels of blood glucose and insulin observed 2 hours after a meal in overweight insulin-resistant human subjects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of a Brown Seaweed Extract on Glycemic Control and Body Weight in Overweight Pre-diabetic Subjects.|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2019|
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 Name: 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 Name: Control
- Change in glucose metabolism [ Time Frame: at baseline and at the end of the intervention (12 week) ]
- Change in insulin secretion [ Time Frame: at baseline and at the end of the intervention (12 week) ]
- Change in body weight [ Time Frame: at baseline and at the end of the intervention (12 week) ]
- Change in body lean mass distribution [ Time Frame: at baseline and at the end of the intervention (12 week) ]
- Change in body fat mass distribution [ Time Frame: at baseline and at the end of the intervention (12 week) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075943
|Institute of Nutrition and Functional Foods (INAF), Laval University|
|Quebec, Canada, G1V 0A6|
|Principal Investigator:||Hélène Jacques, PhD||Institue of Nutrition and Functional Food (INAF), Laval University|