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临床试验/NCT02388672
NCT02388672撤回不适用

Evaluation of Effects of Green Coffee Bean Extract (GCE) on Physiological and Psychological Variables- a Randomized, Placebo-controlled and Double-blinded Study in Healthy Subjects

University Hospital Tuebingen0 个研究点开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
blood pressure

研究概览

简要总结

Coffee as one of the most favorite worldwide beverages comprises a variety of chemicals with health benefits. Most investigations have so far focused on the beneficial effects of caffeine but knowledge about non-caffeine coffee compounds such as chlorogenic acid (CGA) is scarce. The reducing risk of a variety of diseases following CGA consumption has been mentioned in recent basic and clinical studies. However, there is a lack of studies that examine the behavioral effects of CGA. This study aims to fill this gap.

In a randomized double-blind study, the investigators test the acute effects of coffee enriched with CGA or CGA supplement on physiological functions such as blood pressure, blood glucose, and heart rate, and on psychological functions such as mood and cognitive performance in 30 healthy adult subjects (18-40 years).

Participants will be allocated to an intervention plan using computer-generated random numbers. Treatments comprise of (1) 6g decaffeinated (5 mg caffeine) coffee (250 ml) with high total CGA (560 mg), or (2) 6g decaffeinated coffee (250 ml) with normal total CGA (224 mg), or (3) 6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract with total CGA (560mg), or (4) 6g decaffeinated coffee (250 ml) with normal total CGA and placebo, or (5) no treatment group. Upon arrival in the laboratory, participants will complete a 24-hour food recall, a psychometric test battery, and mood and cognitive performance tests. The tests will be repeated 40 min following CGA application, which coincide with the approximated peak of CGA blood concentrations and at 120 min post treatment. Blood pressure, blood glucose and heart rate recordings will be taken prior to treatment and at 1, 30, 60, 90 and 120 min post-treatment. The response to GCE-enriched coffee will be compared to GCE supplement for each of the groups of variables.

详细描述

Coffee as one of the most favorite worldwide beverages comprises a variety of chemicals maintaining the greatest health benefits among the commonly consumed beverages. Most investigations have so far focused on the beneficial effects of caffeine. On the contrary, knowledge on potential health benefits of non-caffeine coffee compounds is scarce. Coffee contains many polyphenols, especially chlorogenic acids (CGA), which have purported antioxidant abilities. With increasing incidence of degenerative diseases, the general public is turning to use natural herbal supplements, as one of these agents, CGA has been biologically and medically emphasized and can be expected to become a topic addressed in future studies, medical trends and pharmacology. The reducing risk of a variety of diseases following CGA consumption has been mentioned in recent basic and clinical studies. However, there is a lack of studies that examine the behavioral effects of CGA. This study aims to fill this gap.

In a randomized double-blind study, the investigators test the acute effects of coffee enriched with CGA or CGA supplement on physiological functions such as blood pressure, blood glucose, and heart rate, and on psychological functions such as mood and cognitive performance in 30 healthy adult subjects (18-40 years).

Participants will be allocated to an intervention plan using computer-generated random numbers. Treatments comprise of (1) 6g decaffeinated (5 mg caffeine) coffee (250 ml) with high total CGA (560 mg), or (2) 6g decaffeinated coffee (250 ml) with normal total CGA (224 mg) , or (3) 6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract with total CGA (560mg), or (4) 6g decaffeinated coffee (250 ml) with normal total CGA and placebo, or (5) no treatment group. Participants will be instructed to abstain from alcohol, foods, and beverages containing caffeine, chlorogenic acids and high polyphenol content for 24 hours prior to the experiment. Upon arrival in the laboratory, participants will complete a 24-hour food recall, a psychometric test battery consisting of the questionnaire on competence and control beliefs (FKK), the Life Orientation Test-Revised (LOT-R), the Beliefs about Medicines Questionnaire (BMQ), the Sensitivity to Punishment and Reward Questionnaire (SPSRQ), General Self-Efficacy (SWE) questionnaire, and mood and cognitive performance tests consisting of the Profile of Mood States (POMS) questionnaire, a parametric Go/no-Go test (PGNG) and the California Verbal Learning Test (CVLT). The POMS, Go/no-Go, and CVLT will be repeated 40 min following CGA application, which coincide with the approximated peak of CGA blood concentrations and at 120 min post treatment. Blood pressure, blood glucose and heart rate recordings will be taken prior to treatment and at 1, 30, 60, 90 and 120 min post-treatment. The response to GCE-enriched coffee will be compared to GCE supplement for each of the groups of variables.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy adults between 18 and 40 years old
  • •Normal weight (BMI > 18 and < 25 kg/m2)
  • •Regular coffee drinkers (1 to 2 cups/day)
  • •Both male and female

排除标准

  • •BMI <18 or >25 kg/m2
  • •Systolic blood pressure (SBP) <100 or >160 mmHg
  • •Diastolic blood pressure (DBP) <50 or >100 mmHg
  • •History of neurological, psychiatric, cardiac, endocrine or other disorders
  • •History of substance abuse
  • •Current use of antihypertensive and psychotropic medication
  • •More than 30 g/day alcohol consumption
  • •Woman who are pregnant or lactating

研究组 & 干预措施

Drink high-CGA

Experimental

Participants will drink once 250ml of decaffeinated coffee enriched with chlorogenic acid (CGA) (6g decaffeinated coffee (5 mg caffeine) with high total CGA (560 mg)).

干预措施: decaffeinated coffee (Dietary Supplement)

Drink low-CGA

Placebo Comparator

6g decaffeinated coffee (250 ml) with normal total CGA (224 mg)

干预措施: decaffeinated coffee (Dietary Supplement)

Capsules high-CGA

Experimental

6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract supplement with total CGA (560mg)

干预措施: decaffeinated coffee (Dietary Supplement)

Capsules high-CGA

Experimental

6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract supplement with total CGA (560mg)

干预措施: green coffee bean extract supplement (Dietary Supplement)

Capsules low-CGA

Placebo Comparator

6g decaffeinated coffee (250 ml) with normal total CGA and placebo

干预措施: decaffeinated coffee (Dietary Supplement)

Capsules low-CGA

Placebo Comparator

6g decaffeinated coffee (250 ml) with normal total CGA and placebo

干预措施: placebo (Dietary Supplement)

Control

No Intervention

No treatment control group

Capsules low-CGA

Placebo Comparator

6g decaffeinated coffee (250 ml) with normal total CGA and placebo

干预措施: chlorogenic acid (Dietary Supplement)

Capsules high-CGA

Experimental

6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract supplement with total CGA (560mg)

干预措施: chlorogenic acid (Dietary Supplement)

Drink low-CGA

Placebo Comparator

6g decaffeinated coffee (250 ml) with normal total CGA (224 mg)

干预措施: chlorogenic acid (Dietary Supplement)

Drink high-CGA

Experimental

Participants will drink once 250ml of decaffeinated coffee enriched with chlorogenic acid (CGA) (6g decaffeinated coffee (5 mg caffeine) with high total CGA (560 mg)).

干预措施: chlorogenic acid (Dietary Supplement)

结局指标

主要结局

blood pressure

时间窗: from baseline to 30 min after intake of CGA

次要结局

  • heart rate(from baseline to 30 min after intake of CGA)
  • blood glucose(from baseline to 30 min after intake of CGA)
  • cognitive performance (parametric go/no-go task)(from baseline to 30 min after intake of CGA)
  • mood (Profile of Mood States (POMS) questionnaire)(from baseline to 30 min after intake of CGA)

研究者

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

Dr. Isabelle Mack

Dr.

University Hospital Tuebingen

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