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临床试验/NCT03745508
NCT03745508已完成不适用

Influence of Coffee Consumption on BIA-derived Body Composition Parameters

University of Alberta2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年1月28日最近更新:
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
26
试验地点
2
主要终点
Body water predicted by bioelectrical impedance

研究概览

简要总结

Body composition analysis is frequently used in both clinical and research settings for evaluation of nutritional status and follow-up. Bioelectrical impedance analysis (BIA) is one method that has been extensively used to measure body composition. To ensure the reliability of BIA results, several recommendations are proposed in the literature. One of them is to avoid coffee and caffeine prior the test. This instruction is primarily based on the potential diuretic effects of caffeine however few studies evaluated the impact of coffee on fluid balance. Research participants usually have several commitments, especially those enrolled in clinical trials. Simplified and evidence-based instructions can avoid unnecessary restrictions and lead to better participant compliance.

详细描述

Body composition analysis is frequently used in both clinical and research settings for evaluation of nutritional status and follow-up. Using only anthropometric measures is outdated considering the increasing transition towards an individualized treatment and the recent advances in body composition assessment.

Methods to evaluate body composition in humans are chosen mostly based on compartment of interest, study population and feasibility. Bioelectrical impedance analysis (BIA) is one method that has been extensively used to measure body composition. This method uses an impedance that can penetrates both intra- and extracellular fluids to estimate total body water, fat-free mass and body fat.

To ensure the reliability of BIA results, several recommendations are proposed in the literature. One of them is to avoid coffee and caffeine prior the test. This instruction is primarily based on the potential diuretic effects of caffeine, which mechanisms are not completely understood. However, few studies evaluated the impact of coffee or caffeine (supplement) on fluid balance.

Coffee is a highly consumed beverage worldwide. Coffee is one of the most consumed beverage among adults in Canada, and most of the caffeine consumed by adults comes from this beverage. In addition, coffee bioactive compounds such as methylxanthines can influence BIA results due its diuretic effect. Research participants usually have several commitments, especially those enrolled in clinical trials. Simplified and evidence-based instructions can avoid unnecessary restrictions and lead to better participant compliance. To the best of our knowledge the current study is the first to explore the effect of coffee with two different amounts of caffeine on BIA-derived body composition parameters.

研究设计

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

盲法说明

Double-blind

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 59 years old;
  • Body Mass Index between 18.5 and 29.9 kg/m^2.

排除标准

  • Women who are menopausal, postmenopausal, pregnant or lactating;
  • Use of certain drugs (i.e. diuretics, steroids, growth hormone) or supplements that affects water balance (i.e. creatine);
  • Participants who have certain known medical conditions (i.e. cardiovascular, edema, diabetes, kidney disease, liver disease, chronic obstructive pulmonary disease, cancer);
  • Participants with any implantable electronic device (e.g. pacemaker, implanted cardiac defibrillator);
  • Participants with hypersensitivity to any of the ingredients of the instant coffee.

研究组 & 干预措施

Caffeinated Coffee (200 mg caffeine)

Active Comparator

~200 mg of caffeine from instant coffee

干预措施: Instant Coffee (Other)

Caffeinated Coffee (400 mg caffeine)

Active Comparator

~400 mg of caffeine from instant coffee

干预措施: Instant Coffee (Other)

Decaffeinated Coffee

Placebo Comparator

Decaffeinated instant coffee

干预措施: Instant Coffee (Other)

结局指标

主要结局

Body water predicted by bioelectrical impedance

时间窗: up to 1.5 hours

To determine whether the consumption of coffee affects the predicted values of body water derived by Bioelectrical Impedance Analysis in healthy adults

Body fat predicted by bioelectrical impedance

时间窗: up to 1.5 hours

To determine whether the consumption of coffee affects the predicted values of body fat derived by Bioelectrical Impedance Analysis in healthy adults

次要结局

未报告次要终点

研究者

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

Carla Prado

Associate Professor

University of Alberta

研究点 (2)

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