search
Back to results

Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women (LCHF)

Primary Purpose

Insulin Sensitivity, Weight

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
LCHF diet and a bout of exercise
Sponsored by
Atlantis Medical University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Sensitivity focused on measuring Insulin sensitivity, Lipid profile, Body composition, Weight

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Norwegian School of Sport Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LCHF diet and a bout of exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

Area under the curve glucose (0, 15, 30, 45, 60, 90 and 120 min)
performed by oral glucose tolerance test, 75 g glucose, 300 ml water

Secondary Outcome Measures

Full Information

First Posted
December 4, 2013
Last Updated
December 6, 2013
Sponsor
Atlantis Medical University College
Collaborators
Norwegian School of Sport Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02005224
Brief Title
Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women
Acronym
LCHF
Official Title
Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atlantis Medical University College
Collaborators
Norwegian School of Sport Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Weight
Keywords
Insulin sensitivity, Lipid profile, Body composition, Weight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCHF diet and a bout of exercise
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
LCHF diet and a bout of exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Area under the curve glucose (0, 15, 30, 45, 60, 90 and 120 min)
Description
performed by oral glucose tolerance test, 75 g glucose, 300 ml water
Time Frame
-1 week, 3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorgen Jensen, PhD
Organizational Affiliation
Norwegian School of Sport Sciences - Department of Physical Performance
Official's Role
Study Director
Facility Information:
Facility Name
Norwegian School of Sport Sciences
City
Oslo
ZIP/Postal Code
0806
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women

We'll reach out to this number within 24 hrs