- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02005224
Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women (LCHF)
December 6, 2013 updated by: Atlantis Medical University College
Intervention studying the effect of a low-carbohydrate/high-fat (LCHF) diet as well as on bout of exercise in combination with either a normal diet or a LCHF diet, in relation to glucose metabolism, insulin sensitivity, lipid profile and body composition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oslo, Norway, 0806
- Norwegian School of Sport Sciences
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-
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
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Females
- Normal weight
- BMI between 18.5 and 25
- Moderately trained
Exclusion Criteria:
- Smokers/tobacco users
- pregnancy
- familial cardio-vascular-disease
- diabetes or reduced glucose tolerance
- under- or overweight (BMI under 18.5 or over 25)
- top athletes
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
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: LCHF diet and a bout of exercise
LCHF diet for 3 weeks, where E% 70 fat, E% 20-25 proteins and 20g or less carbohydrates.
Oral glucose tolerance test on the morning of day 21 followed by a bout of exercise in the afternoon (indoor bicycle, 60min at 75% HFpeak).
The following morning (day 22) a new oral glucose tolerance test.
Oral glucose tolerance test results from pre-tests used to determine the effect of LCHF and a bout of exercise on insulin sensitivity.
|
Low-carbohydrate/high-fat diet; effect on insulin sensitivity, lipid profile, weight and body composition.
Participants ingested LCHF diet for three weeks before undergoing an oral glucose tolerance test.
The same afternoon the participated in an one hour indoor bicycle training at 75% at HFpeak.
The following morning they underwent a new oral glucose tolerance test.
Body composition and weight were measured before and after the intervention.
Oral glucose tolerance test was also performed before the intervention for baseline.
Blood samples were collected before and after the intervention for lipid profile analyses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve glucose (0, 15, 30, 45, 60, 90 and 120 min)
Time Frame: -1 week, 3 weeks
|
performed by oral glucose tolerance test, 75 g glucose, 300 ml water
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-1 week, 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Jorgen Jensen, PhD, Norwegian School of Sport Sciences - Department of Physical Performance
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
August 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
December 4, 2013
First Submitted That Met QC Criteria
December 6, 2013
First Posted (Estimate)
December 9, 2013
Study Record Updates
Last Update Posted (Estimate)
December 9, 2013
Last Update Submitted That Met QC Criteria
December 6, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMUC-NIH-LCHF-P1-2012
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.
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