HealthyNCT03745508
Influence of Coffee Consumption on BIA-derived Body Composition Parameters
A study testing Instant Coffee in people with Healthy, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Instant Coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2019to 5 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 to 59 years old;
- Body Mass Index between 18.5 and 29.9 kg/m^2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Instant Coffee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instant CoffeeOther
Instant coffee prepared at different caffeine concentrations
| Study group | Role | What they receive |
|---|---|---|
| Caffeinated Coffee (200 mg caffeine) | Active comparator | ~200 mg of caffeine from instant coffee Receives: Other: Instant Coffee |
| Caffeinated Coffee (400 mg caffeine) | Active comparator | ~400 mg of caffeine from instant coffee Receives: Other: Instant Coffee |
| Decaffeinated Coffee | Placebo comparator | Decaffeinated instant coffee Receives: Other: Instant Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start28 Jan 2019
- Primary completion5 Jul 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla Prado, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745508
- Sponsor's protocol ID
- Pro00085821
- Status last verified
- Jul 2019
- First submitted
- 14 Nov 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Coffee Consumption on BIA-derived Body Composition Parameters
- ClinicalTrials.gov ID
- NCT03745508
- Acronym / sponsor ID
- Pro00085821
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caffeinated Coffee (200 mg caffeine) | Active comparator | Other: Instant Coffee~200 mg of caffeine from instant coffee |
| Caffeinated Coffee (400 mg caffeine) | Active comparator | Other: Instant Coffee~400 mg of caffeine from instant coffee |
| Decaffeinated Coffee | Placebo comparator | Other: Instant CoffeeDecaffeinated instant coffee |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged 18 to 59 years old;
- Body Mass Index between 18.5 and 29.9 kg/m^2.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instant CoffeeInstant coffee prepared at different caffeine concentrations | Other | Caffeinated Coffee (200 mg caffeine), Caffeinated Coffee (400 mg caffeine), Decaffeinated Coffee |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Prado, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instant Coffee in people with Healthy, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat predicted by bioelectrical impedance (time frame: up to 1.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.