OverweightNCT02888405
Effects of Acute Dietary Changes on Estimates of Body Composition
A study testing High-carbohydrate diet and Low-carbohydrate diet in people with Overweight, run by Baylor University.
Trial summary
The present study sought to investigate the effects of acute dietary changes on estimates of body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of carbohydrate) were examined. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- High-carbohydrate diet and Low-carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Feb 2016
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- Recreationally active (>150 min/week of moderate or vigorous physical activity)
- Pre-menopausal with regularly occurring menstrual cycles over past 6 months (in females only)
Who cannot join
- Failure to meet inclusion criteria
- Commencement or cessation of taking the dietary supplement creatine within the past month
- Pregnant or may become pregnant during the study
- Known or suspected food allergy to any items used in study
- Presence of medical condition that could reasonably be negatively affected by participation
About this study
The present study sought to investigate the effects of acute dietary changes on estimates of body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of carbohydrate) were examined.
- Conditions
- Overweight
- Being tested
- High-carbohydrate diet, Low-carbohydrate diet
- Keywords
- Body Composition
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-carbohydrate dietOther
Low-carbohydrate dietOther
| Study group | Role | What they receive |
|---|---|---|
| High-carbohydrate diet | Experimental | Single day of 9 g/kg body weight consumption of carbohydrate. Isocaloric to very low-carbohydrate condition. Receives: Other: High-carbohydrate diet |
| Very low-carbohydrate diet | Experimental | Single day of 1 - 1.5 g/kg body weight consumption of carbohydrate. Isocaloric to high-carbohydrate condition. Receives: Other: Low-carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-energy X-ray Absorptiometry Output
Measures of lean soft tissue and fat mass obtained from dual-energy x-ray absorptiometry.
Measured: 2 days
Bioelectrical Impedance Analysis Output
Measures of fat-free mass and fat mass obtained from bioelectrical impedance analysis.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888405
- Sponsor's protocol ID
- 805223-2
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Dietary Changes on Estimates of Body Composition
- ClinicalTrials.gov ID
- NCT02888405
- Acronym / sponsor ID
- 805223-2
- Conditions
- Overweight
- Keywords
- Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Sep 2016 (estimated)
- 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.
The present study sought to investigate the effects of acute dietary changes on estimates of body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of carbohydrate) were examined.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-carbohydrate diet | Experimental | Other: High-carbohydrate dietSingle day of 9 g/kg body weight consumption of carbohydrate. Isocaloric to very low-carbohydrate condition. |
| Very low-carbohydrate diet | Experimental | Other: Low-carbohydrate dietSingle day of 1 - 1.5 g/kg body weight consumption of carbohydrate. Isocaloric to high-carbohydrate condition. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Generally healthy
- Recreationally active (>150 min/week of moderate or vigorous physical activity)
- Pre-menopausal with regularly occurring menstrual cycles over past 6 months (in females only)
Key exclusion criteria (5 listed)
- Failure to meet inclusion criteria
- Commencement or cessation of taking the dietary supplement creatine within the past month
- Pregnant or may become pregnant during the study
- Known or suspected food allergy to any items used in study
- Presence of medical condition that could reasonably be negatively affected by participation
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 |
|---|---|---|
| High-carbohydrate diet | Other | High-carbohydrate diet |
| Low-carbohydrate diet | Other | Very low-carbohydrate diet |
Primary outcome
Dual-energy X-ray Absorptiometry Output
Time frame: 2 days
Measures of lean soft tissue and fat mass obtained from dual-energy x-ray absorptiometry.
Bioelectrical Impedance Analysis Output
Time frame: 2 days
Measures of fat-free mass and fat mass obtained from bioelectrical impedance analysis.
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 5 Sep 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High-carbohydrate diet and Low-carbohydrate diet in people with Overweight, run by Baylor University.
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 3 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 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Dual-energy X-ray Absorptiometry Output (time frame: 2 days). 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 5 Sep 2016.