Influence of Coffee Consumption on BIA-derived Body Composition Parameters

NCT03745508 | Completed

• 1 other identifier: Pro00085821
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Body fat predicted by bioelectrical impedance

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

  up to 1.5 hours

• Body water predicted by bioelectrical impedance

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

  up to 1.5 hours

Study Arms (3)

Caffeinated Coffee (200 mg caffeine)

ACTIVE COMPARATOR

\~200 mg of caffeine from instant coffee

Other: Instant Coffee

Caffeinated Coffee (400 mg caffeine)

ACTIVE COMPARATOR

\~400 mg of caffeine from instant coffee

Other: Instant Coffee

Decaffeinated Coffee

PLACEBO COMPARATOR

Decaffeinated instant coffee

Other: Instant Coffee

Interventions

Instant Coffee OTHER

Instant coffee prepared at different caffeine concentrations

Caffeinated Coffee (200 mg caffeine); Caffeinated Coffee (400 mg caffeine); Decaffeinated Coffee

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Study Officials

• Carla Prado, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 19, 2018
• Study Start: January 28, 2019
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2019
• Last Updated: September 19, 2024

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)