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临床试验/NCT02903199
NCT02903199Unknown不适用

The Effect of Pre-meal Whey Protein on Glycaemic and Appetite Responses in Type II Diabetic Males

Northumbria University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
11
试验地点
2
主要终点
Postprandial capillary glucose

研究概览

简要总结

The current study will investigate the effect if whey protein on postprandial glycaemia and appetite in type II diabetics, assessing incretin (GLP-1, GIP), insulin, and appetite control (leptin, PYY3-36) hormone responses.

详细描述

Whey protein accounts of ~20% of whole milk protein. Ingestion of whey protein at meal times generates insulinotrophic/β-cell stimulation via amino acid absorption and the bioactive peptides generated during gastrointestinal digestion, resulting in attenuation of postprandial blood glucose. The bioactive peptides stimulate the release of incretin hormone, GLP-1, and inhibit DPP-IV activity potentially decreasing the rate of GLP-1 degradation.

The current study will employ a randomised, double-blind, counter-balanced, cross-over design, whereby participants will each complete three trials; a) whey protein, b) hydrolysed protein, and c) placebo intervention. Hydrolysed protein provides amino acid content, without bioactive peptides associated with incretin release, therefore, demonstrating insulinotrophic properties, only.

Many studies within the literature are limited for practical reasons, such as investigating high dosages (30-50 g) of whey protein, or high glycaemic index meal types which would be unlikely to form part of habitual dietary activity of type II diabetics. Therefore, the current study will objectively measure postprandial glycaemic and appetite responses following the ingestion of whey/hydrolysed protein, whilst ensuring ecological validity, dosages (18 g) and test meals applicable to everyday life, and true clinical utility for managing type-II diabetes by integrating interventions into the habitual lives of type-II diabetic individuals.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Type II diabetic males aged 18-65 years old.
  • Treated with metformin, or diet and lifestyle modification, only.
  • BMI < 40 kg/m
  • Stable physical activity pattern during the three months immediately preceding study.

排除标准

  • Not treated with insulin.
  • No metabolic disease other than diabetes.

结局指标

主要结局

Postprandial capillary glucose

时间窗: 6 hours per week, for 3 weeks.

Capillary glucose concentrations are monitored for 6 hours/wk following breakfast (09:00-12:00) and lunch (12:15-15:15).

次要结局

  • Plasma Gastric Inhibitory Polypeptide (GIP)(3 weeks)
  • Plasma Glucagon-like Peptide-1 (GLP-1)(3 weeks)
  • Plasma Leptin(3 weeks)
  • Plasma Peptide YY (PYY3-36)(3 weeks)
  • Self-Report Questionnaire for Appetite(3 weeks)
  • Plasma Insulin(3 weeks)
  • Serum Triglycerides(3 weeks)
  • Serum Glycerol(3 weeks)
  • 24 h Interstitial Glucose(3 days per week, for 3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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