NCT02005224

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

August 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

December 4, 2013

Last Update Submit

December 6, 2013

Conditions

Keywords

Insulin sensitivityLipid profileBody compositionWeight

Outcome Measures

Primary Outcomes (1)

  • 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

    -1 week, 3 weeks

Study Arms (1)

LCHF diet and a bout of exercise

OTHER

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.

Other: LCHF diet and a bout of exercise

Interventions

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.

LCHF diet and a bout of exercise

Eligibility Criteria

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

You may qualify if:

  • Females
  • Normal weight
  • BMI between 18.5 and 25
  • Moderately trained

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, 0806, Norway

Location

MeSH Terms

Conditions

Insulin ResistanceBody Weight

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jorgen Jensen, PhD

    Norwegian School of Sport Sciences - Department of Physical Performance

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 9, 2013

Study Start

August 1, 2012

Primary Completion

November 1, 2012

Study Completion

March 1, 2013

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations