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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02888405
Other study ID # 805223-2
Secondary ID
Status Completed
Phase N/A
First received August 19, 2016
Last updated August 30, 2016
Start date November 2015
Est. completion date February 2016

Study information

Verified date August 2016
Source Baylor University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
High-carbohydrate diet

Low-carbohydrate diet


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Baylor University

Outcome

Type Measure Description Time frame Safety issue
Primary Dual-energy X-ray Absorptiometry Output Measures of lean soft tissue and fat mass obtained from dual-energy x-ray absorptiometry. 2 days No
Primary Bioelectrical Impedance Analysis Output Measures of fat-free mass and fat mass obtained from bioelectrical impedance analysis. 2 days No
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