Double-blind, Randomized, Controlled, Cross-over Trial on Glycemic Response to Low Sugar Apple Juice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- incremental area under the postprandial glucose curve
研究概览
简要总结
Primary objective of this study is to investigate the effect of sugar reduction (starting from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by comparing the reference food item apple juice (control) with the test product (apple juice with low sugar content) in male humans with impaired fasting glucose (IFG) (5.6-6.9mmol/l resp. 100-125mg/dL) (Kerner and Brückel, 2012 (DDG recommendation)) Secondary objective of this study is to investigate the effect of sugar reduction on postprandial insulinemic response.
Exploratory objectives are to investigate further characteristics of postprandial glucose and insulin response and insulin sensitivity, gastrointestinal side effects and safety aspects.
详细描述
Objectives:
Investigating the effect of sugar reduction in apple juice on glycemic and insulin response to ingestion of this drink.
Subjects/Methods:
In a double-blind randomized placebo-controlled clinical trial with cross-over design 30 male adults with impaired fasting glucose (IFG) received an oral drink of 500mL: 1. Verum: Apple juice, treated (low sugar content); 2. Control: Untreated apple juice (normal sugar content). Capillary blood glucose and venous plasma insulin were measured twice at baseline and then at times 0 (start of drink), 15, 30, 45, 60, 90 and 120 min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged ≥ 18y
- •diagnosed impaired fasting glucose (IFG)
- •Written informed consent
排除标准
- •Subjects currently enrolled in another clinical study
- •Subjects having finished another clinical study within the last 4 weeks before inclusion
- •Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food
- •Acute or chronic infections
- •Renal insufficiency
- •Gastrointestinal illness
- •History of gastrointestinal surgery
- •Known fructose intolerance
- •Overt Diabetes mellitus
- •Endocrine disorders
- •Any disease or condition which might compromise significantly the hematopoietic, renal, endocrine, pulmonary, hepatic, cardiovascular, immunological, central nervous, dermatological or any other body System with the exception of the conditions defined by the inclusion criteria
- •History of hepatitis B and C
- •History of HIV infection
- •History of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid)
- •Regular medical treatment including OTC, which may have impact on the study aims (e.g. antidiabetic drugs, laxatives etc.)
- •Major cognitive or psychiatric disorders
- •Subjects who are scheduled to undergo hospitalization during the study period
- •Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)
- •Present drug abuse or alcoholism
- •Legal incapacity
结局指标
主要结局
incremental area under the postprandial glucose curve
时间窗: 120 min postprandially
次要结局
- incremental area under the postprandial insulin curve(120 min postprandially)