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临床试验/NCT03075943
NCT03075943已完成不适用

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

Laval University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Changes in blood glucose (mmol/L)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Changes in blood glucose (mmol/L)

时间窗: at baseline and at the end of the intervention (12 week)

glucose in the fasting state and during a 2h-OGTT

Changes in blood insulin (pmol/L) and C-peptide (pmol/L)

时间窗: at baseline and at the end of the intervention (12 week)

insulin and C-peptide in the fasting state and during a 2h-OGTT

Changes in anthropometrics

时间窗: at baseline and at the end of the intervention (12 week)

body weight (kg), lean mass (kg) and fat mass (kg)

次要结局

  • Changes in markers of gut barrier integrity(at baseline and at the end of the intervention (12 week))
  • Changes in marker of oxidative stress(at baseline and at the end of the intervention (12 week))
  • Changes in blood pressure(at baseline and at the end of the intervention (12 week))
  • Changes in heart rate(at baseline and at the end of the intervention (12 week))
  • Changes in Il-6(at baseline and at the end of the intervention (12 week))
  • Changes in hsCRP(at baseline and at the end of the intervention (12 week))
  • Changes in lipid profile(at baseline and at the end of the intervention (12 week))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Helene Jacques

Professor

Laval University

研究点 (2)

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