NCT02888405

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
Last Updated

September 5, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

August 19, 2016

Last Update Submit

August 30, 2016

Conditions

Keywords

Body Composition

Outcome Measures

Primary Outcomes (2)

  • Dual-energy X-ray Absorptiometry Output

    Measures of lean soft tissue and fat mass obtained from dual-energy x-ray absorptiometry.

    2 days

  • Bioelectrical Impedance Analysis Output

    Measures of fat-free mass and fat mass obtained from bioelectrical impedance analysis.

    2 days

Study Arms (2)

High-carbohydrate diet

EXPERIMENTAL

Single day of 9 g/kg body weight consumption of carbohydrate. Isocaloric to very low-carbohydrate condition.

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.

Other: Low-carbohydrate diet

Interventions

High-carbohydrate diet
Very low-carbohydrate diet

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Overweight

Interventions

Diet, High-Protein Low-CarbohydrateDiet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDiet, High-ProteinDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

September 5, 2016

Study Start

November 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

September 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share