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临床试验/NCT02291250
NCT02291250Unknown不适用

Effect of Soft Fruit on Postprandial Blood Glucose

University of Aberdeen1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
16
试验地点
1
主要终点
Plasma Glucose Area Under the Curve

研究概览

简要总结

Dietary strategies for alleviating health complications associated with type 2 diabetes (T2D) are being pursued as alternatives to pharmaceutical interventions. Berries such as blackcurrants that are rich in polyphenols may influence carbohydrate digestion and absorption and thus postprandial glycaemia. In addition berries have been reported to alter incretins as well as to have anti-oxidant and anti-inflammatory properties that may also affect postprandial glycaemia. This study investigated the acute affect blackcurrants on glucose metabolism in overweight/obese volunteers .

详细描述

Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

The consumption of the currants will be followed by an oral glucose tolerance test (OGTT) with Polycal (complex carbohydrate) or glucose (simple carbohydrate) as the carbohydrate load.

There will be a one week minimum wash out period between each intervention. All interventions will be randomised and blinded as far as possible in a cross-over design where the volunteers are acting as their own control. The volunteers will be asked to consume a low phytochemical diet three days prior to taking the currants all occasions. In addition, they will be asked to record what they ate over the same period in a simple food diary.

The following intervention will be carried out on 16 overweight/obese male/postmenopausal female non-smoker volunteers:

  1. Control: sugar matched (matched to currant sugar content) water with polycal (complex carbohydrate load)
  2. Blackcurrants (which contain anthocyanins; 200grams) with polycal (complex carbohydrate load)
  3. Blackcurrants (which contain anthocyanins; 200grams) with glucose (simple carbohydrate load)
  4. Greencurrants (which naturally contain no anthocyanins; 200grams) with polycal (complex carbohydrate load)

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
Single (Participant)

入排标准

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

入选标准

  • •Obese male or female (postmenopausal) healthy non-smoking volunteers (BMI over 25kg/m2)
  • •Aged >21 and <70 years

排除标准

  • •Medical exclusion criteria
  • •Chronic illness, including:
  • •thromboembolic or coagulation disease
  • •unregulated thyroid disease
  • •kidney disease
  • •hepatic disease
  • •severe gastrointestinal disorders
  • •pulmonary disease (e.g. chronic bronchitis, COPD)
  • •Alcohol or any other substance abuse
  • •Eating disorders
  • •Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders)
  • •Non-postmenopausal women
  • •Medication exclusion criteria
  • •Oral steroids
  • •Tricyclic antidepressants, neuroleptics
  • •Anticoagulants
  • •Digoxin and anti-arrhythmics
  • •Chronic use of anti-inflammatories (e.g. high doses of aspirin, ibuprofen), Insulin, -Sulphonylureas, Thiazolidinediones (glitazones), metformin.
  • •Anti-obesity medication e.g. Orlistat

研究组 & 干预措施

Sugar matched water with polycal OGTT

Experimental
  1. Control: sugar matched (matched to currant sugar content) water with polycal
  2. Blackcurrants (200grams) with polycal
  3. Blackcurrants (200grams) with glucose
  4. Greencurrants (200grams) with polycal Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

The OGTT will be carried out with glucose as a simple carbohydrate load or polycal as a complex carbohydrate load.

Volunteers will be randomised into four groups (n=4 per group). One week wash out between treatments

干预措施: Sugar matched water with polycal OGTT (Dietary Supplement)

Blackcurrants with polycal OGTT

Experimental
  1. Blackcurrants (200grams) with polycal
  2. Blackcurrants (200grams) with glucose
  3. Greencurrants ( 200grams) with polycal
  4. Control: sugar matched (matched to currant sugar content) water with polycal

Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

The OGTT will be carried out with glucose as a simple carbohydrate load or polycal as a complex carbohydrate load as decribed above.

Volunteers will be randomised into four groups (n=4 per group). One week wash out between treatments

干预措施: Blackcurrants with polycal OGTT (Dietary Supplement)

Blackcurrants with glucose OGTT

Experimental
  1. Blackcurrants (200grams) with glucose
  2. Greencurrants (200grams) with polycal
  3. Control: sugar matched (matched to currant sugar content) water with polycal
  4. Blackcurrants (200grams) with polycal

Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

The OGTT will be carried out with glucose as a simple carbohydrate load or polycal as a complex carbohydrate load as decribed above

Volunteers will be randomised into four groups (n=4 per group). One week wash out between treatments

干预措施: Blackcurrants with glucose OGTT (Dietary Supplement)

Greencurrants with polycal OGTT

Experimental
  1. Greencurrants (200grams) with polycal
  2. Control: sugar matched (matched to currant sugar content) water with polycal
  3. Blackcurrants (200grams) with polycal
  4. Blackcurrants (200grams) with glucose

Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

The OGTT will be carried out with glucose as a simple carbohydrate load or polycal as a complex carbohydrate load as decribed above.

Volunteers will be randomised into four groups (n=4 per group). One week wash out between treatments.

干预措施: Greencurrants with polycal OGTT (Dietary Supplement)

结局指标

主要结局

Plasma Glucose Area Under the Curve

时间窗: Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post currant ingestion

次要结局

  • Plasma Insulin Area Under the Curve(Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post currant ingestion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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