Insulin SensitivityLCHFNCT02005224
Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women
A study testing LCHF diet and a bout of exercise in people with Insulin Sensitivity and Weight, run by Atlantis Medical University College at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Weight
- What is being tested?
- LCHF diet and a bout of exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females
- Normal weight
- BMI between 18.5 and 25
- Moderately trained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Insulin Sensitivity, Weight
- Being tested
- LCHF diet and a bout of exercise
- Keywords
- Insulin sensitivity, Lipid profile, Body composition, Weight
- Medical subject headings
- Insulin Resistance, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCHF diet and a bout of exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: LCHF diet and a bout of exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: -1 week, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantis Medical University College
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Responsible party
- Sponsor
- Investigators
- Jorgen Jensen, PhD, Study director, Norwegian School of Sport Sciences - Department of Physical Performance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005224
- Sponsor's protocol ID
- AMUC-NIH-LCHF-P1-2012
- Acronym
- LCHF
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women
- ClinicalTrials.gov ID
- NCT02005224
- Acronym / sponsor ID
- LCHF / AMUC-NIH-LCHF-P1-2012
- Conditions
- Insulin Sensitivity, Weight
- Keywords
- Insulin sensitivity, Lipid profile, Body composition, Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Atlantis Medical University CollegeUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCHF diet and a bout of exercise | Other | Other: LCHF diet and a bout of exerciseLCHF 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females
- Normal weight
- BMI between 18.5 and 25
- Moderately trained
Key exclusion criteria (6 listed)
- Smokers/tobacco users
- pregnancy
- familial cardio-vascular-disease
- diabetes or reduced glucose tolerance
- under- or overweight (BMI under 18.5 or over 25)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCHF diet and a bout of exerciseLow-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. | Other | LCHF diet and a bout of exercise |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorgen Jensen, PhD study director
Norwegian School of Sport Sciences - Department of Physical Performance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCHF diet and a bout of exercise in people with Insulin Sensitivity and Weight, run by Atlantis Medical University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve glucose (0, 15, 30, 45, 60, 90 and 120 min) (time frame: -1 week, 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.