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临床试验/NCT02608372
NCT02608372已完成不适用

Effect of Brown Seaweeds on Glycaemia, Gastric Emptying, and Appetite: A Randomized, Controlled Crossover Meal Study

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Plasma glucose Area Under the Curve (Glucose AUC)

研究概览

简要总结

The project is a randomized, 3-way, blinded crossover trial in which 20 healthy, fasted participants consume meals with 30 g of a linear corn starch and 5 g of one of the seaweeds, Laminara digitata or Undaria pinnatifida or a pea protein control. The primary aim is to investigate whether the brown seaweeds affect the postprandial glucose Area Under the Curve (AUC). Stomach emptying, insulin, C-peptide, appetite-regulating hormones (oxyntomodulin, glucagon, GLP-1 and PYY), and specific metabolites from the seaweeds in the urine and plasma as well as subjective satiety are also analyzed.

详细描述

Brown seaweeds may contain bioactive compounds as they contain secondary plant metabolites, including flavonoids and other phenolic compounds as well as carotenoids. Dietary fibre is the major component of brown seaweeds, mainly composed from laminarans, alginates, fucans and cellulose. Several dietary fibers and secondary plant metabolites have been shown to have an impact on health and more specifically on glycemic control. Therefore, the aim of this study was to investigate whether two selected brown seaweeds have an effect on the postprandial glucose response to a starch load as well as several secondary measures, including appetite responses.

In a controlled crossover trial, 20 healthy fasted participants consumed 5 g of either Laminaria digitata (LD) or Undaria pinnatifida (UP) or 1 g of pea protein (CTR). The volunteers concomitantly ingested 200 mL of a drink with corn starch. Blood samples were drawn at baseline, as well as 20, 40, 60, 90, 120 and 180 min after the meal. Differences in glucose, insulin, C-peptide, plasma incretin concentrations, and insulin sensitivity index (ISI) were analyzed and appetite was scored by a visual analogue scale and a subsequent ad libitum test meal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 20-25 kg/m
  • Waist circumference < 102 cm. Non-smoking. Like (can tolerate) seaweed, pasta, meat sauce as these foods are part of the test meal.
  • Can tolerate paracetamol (Pinex, Actavis, Denmark).

排除标准

  • Systemic infections, psychiatric or metabolic diseases, and any clinical condition, chronic or frequent use of medication (including blood thinners, excluding contraceptives), smoking (throughout the trial and 12 months before the start of the experiment), blood donations during or in the month leading up to the study period, elite athletes (> 10 hours of hard exercise / week, self-reported), high intake of alcohol (defined as a weekly intake of > 7 units for women and > 14 units for men), have or have had a drug addiction, participation in other scientific studies during the study period, lactating, pregnancy or ongoing planning of pregnancy, and vegetarianism or veganism.

研究组 & 干预措施

Sequence D

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-CTR-LD

干预措施: UP (Other)

Sequence A

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-UP-CTR

干预措施: LD (Other)

Sequence A

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-UP-CTR

干预措施: UP (Other)

Sequence A

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-UP-CTR

干预措施: CTR (Other)

Sequence B

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-CTR-UP

干预措施: LD (Other)

Sequence B

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-CTR-UP

干预措施: UP (Other)

Sequence B

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence LD-CTR-UP

干预措施: CTR (Other)

Sequence C

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-LD-CTR

干预措施: LD (Other)

Sequence C

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-LD-CTR

干预措施: UP (Other)

Sequence C

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-LD-CTR

干预措施: CTR (Other)

Sequence D

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-CTR-LD

干预措施: LD (Other)

Sequence D

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence UP-CTR-LD

干预措施: CTR (Other)

Sequence E

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-LD-UP

干预措施: LD (Other)

Sequence E

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-LD-UP

干预措施: UP (Other)

Sequence E

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-LD-UP

干预措施: CTR (Other)

Sequence F

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-UP-LD

干预措施: LD (Other)

Sequence F

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-UP-LD

干预措施: UP (Other)

Sequence F

Experimental

The meal study was performed with Laminaria digitata (LD), Undaria pinnatifida (UP) or pea protein drink (CTR) in the sequence CTR-UP-LD

干预措施: CTR (Other)

结局指标

主要结局

Plasma glucose Area Under the Curve (Glucose AUC)

时间窗: 0- 180 min

The area under the plasma glucose concentration curve was calculated from 0-180 min after 30 g of corn starch was ingested.

次要结局

  • Plasma GLP-1 Area Under the Curve(0-180 min)
  • ISI (0-180)(0-180 min)
  • Subjective appetite scores assessed by visual analogue scale (VAS)(20, 40, 50, 70, 100, 130 and 180 min)
  • Serum Insulin Area Under the Curve(0-180 min)
  • Serum Insulin concentrations(: 20, 40, 60, 90, 120 and 180 min)
  • Serum C-peptide Area Under the Curve(0-180 min)
  • Serum C-peptide concentrations(20, 40, 60, 90, 120 and 180 min)
  • Plasma glucose concentrations(20, 40, 60, 90, 120 and 180 min)
  • Plasma GLP-1 concentrations(20, 40, 60, 90, 120 and 180 min)

研究者

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

Professor Lars Ove Dragsted

Professor

University of Copenhagen

研究点 (2)

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