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Influence of Coffee Consumption on BIA-derived Body Composition Parameters

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ClinicalTrials.gov Identifier: NCT03745508
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Carla Prado, University of Alberta

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Other: Instant Coffee Not Applicable

Detailed Description:

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 Using only anthropometric measures is outdated considering the increasing transition towards an individualized treatment and the recent advances in body composition assessment.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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Other
Official Title: Influence of Coffee Consumption on BIA-derived Body Composition Parameters
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Active Comparator: Caffeinated Coffee (200 mg caffeine)
~200 mg of caffeine from instant coffee
Other: Instant Coffee
Instant coffee prepared at different caffeine concentrations

Active Comparator: Caffeinated Coffee (400 mg caffeine)
~400 mg of caffeine from instant coffee
Other: Instant Coffee
Instant coffee prepared at different caffeine concentrations

Placebo Comparator: Decaffeinated Coffee
Decaffeinated instant coffee
Other: Instant Coffee
Instant coffee prepared at different caffeine concentrations




Primary Outcome Measures :
  1. Body fat predicted by bioelectrical impedance [ Time Frame: 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

  2. Body water predicted by bioelectrical impedance [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745508


Contacts
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Contact: Claire Trottier, BSc 7804927820 ctrottie@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Carla Prado, PhD University of Alberta

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Responsible Party: Carla Prado, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03745508     History of Changes
Other Study ID Numbers: Pro00085821
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents