- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02888405
Effects of Acute Dietary Changes on Estimates of Body Composition
August 30, 2016 updated by: Baylor University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High-carbohydrate diet
Single day of 9 g/kg body weight consumption of carbohydrate.
Isocaloric to very low-carbohydrate condition.
|
|
Experimental: Very low-carbohydrate diet
Single day of 1 - 1.5 g/kg body weight consumption of carbohydrate.
Isocaloric to high-carbohydrate condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 days
|
Bioelectrical Impedance Analysis Output
Time Frame: 2 days
|
Measures of fat-free mass and fat mass obtained from bioelectrical impedance analysis.
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
August 19, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (Estimate)
September 5, 2016
Study Record Updates
Last Update Posted (Estimate)
September 5, 2016
Last Update Submitted That Met QC Criteria
August 30, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 805223-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsNot yet recruitingOverweight and Obesity | Overweight, Childhood | Overweight, Infant
-
Children's Hospital Los AngelesUniversity of Southern California; Tufts Medical CenterRecruitingOverweight and Obesity | Overweight AdolescentsUnited States
-
University of AarhusThe Danish Dairy Research Foundation, Denmark; Sygekassernes HelsefondCompletedOverweight and Obesity | Overweight Adolescents | Metabolic DiseaseDenmark
-
Memorial Sloan Kettering Cancer CenterRecruitingObesity | Overweight | Overweight and Obesity | Obese | Overweight or ObesityUnited States
-
University Hospital Bispebjerg and FrederiksbergUniversity of CopenhagenCompleted
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Khyber Medical University PeshawarRecruitingObesity, OverweightPakistan
-
National Taiwan University HospitalCompleted
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
Children's Hospital SrebrnjakBelupo; Podravka d.d.RecruitingBody Weight | Overweight and ObesityCroatia
Clinical Trials on High-carbohydrate diet
-
Uppsala UniversityCompleted
-
UCSF Benioff Children's Hospital OaklandNational Cattlemen's Beef AssociationCompletedHealthy | Cardiovascular Disease | Atherogenic DyslipidemiaUnited States
-
Brigham and Women's HospitalBoston Children's Hospital; Boston Medical Center; Nutrition Science Initiative; New Balance Foundation and other collaboratorsCompleted
-
Haukeland University HospitalUniversity of BergenCompleted
-
Vårdcentralen LyckornaCompleted
-
National University of SingaporeActive, not recruitingPersonalized NutritionSingapore
-
Kaiser PermanenteNational Center for Complementary and Integrative Health (NCCIH)CompletedHypertension | ObesityUnited States
-
University of Alabama at BirminghamGeneral MillsCompletedObesity | PreDiabetesUnited States
-
Hvidovre University HospitalCompletedType 1 DiabetesDenmark
-
University of NottinghamMars, Inc.Completed