Overweight and ObesityNCT04100356
The Effect of Exercise and/or Diet on Health Related Parameters
A study testing Exercise, Normal Diet and LCHF Diet in people with Overweight and Obesity, run by Atlantis Medical University College at 1 site in Norway.
Trial summary
The study evaluates the effect of exercise and/or diet during on body weight, body composition and health related blood parameters. Participants are overweight sedentary females, allocated to four different groups: Normal diet, Low-carb-high-fat diet, Normal diet + exercise, Low-carb-high-fat diet + exercise. Read more about this study
- Who is it for?
- Ages 33 to 47 years, women only
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Exercise, Normal Diet and LCHF Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteNorway
- Study dates
- 21 Jan 2014to 23 Apr 2014
- 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 33 to 47 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women
- Sedentary
- Premenopausal
- Caucasian
- BMI 26.9 - 36.1
- Age 33-4
- Living close to, or in Oslo.
Who cannot join
- Pregnancy
- Breast-feeding
- Smoking or tobacco use
- Previous medical history of cardio-vascular disease (CVD)
- Previous medical history of diabetes
- Previous medical history of endocrine disorder
Show all 9Show fewer
- Previous medical history of kidney disease
- Use of lipid lowering medication
- Use of diabetes medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise and/or Diet Body Composition, Cardiorespiratory Fitness and Blood Parameters Related to Improved Health in Overweight Females.
The study evaluates the effect of exercise and/or diet during on body weight, body composition and health related blood parameters. Participants are overweight sedentary females, allocated to four different groups: Normal diet, Low-carb-high-fat diet, Normal diet + exercise, Low-carb-high-fat diet + exercise.
Read the detailed description
Diet and exercise can both be efficient tools to reduce bodyweight, get healthier body composition and improve many different health related blood parameters such as cholesterol and glucose tolerance.
Exercise has superior effect on skeletal muscle in the context of glucose tolerance, but adherence to exercise program can be a huge challenge for overweight individuals. While exercise has profound effect on metabolic health, diet has been superior when it comes to weight reduction. Previous studies have shown that 5-7% weight loss can improve glucose tolerance, measured as reduced fasting glucose and reduced 2-hour post prandial glucose.
We wish to see if the combination exercise and diet is superior to diet only when it comes to over all health.
- Conditions
- Overweight and Obesity
- Being tested
- Exercise, Normal Diet, LCHF Diet
- Keywords
- Low-carbohydrate-high-fat diet (LCHF), Low-density-lipoprotein (LDL), High-density-lipoprotein (HDL), Triglycerides (TG), Lipids, Glucose tolerance (GT), Insulin resistance (IR), Body composition, Weight
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise program - indoor bicycle interval exercise, duration 60 min 3x week
Normal DietOther
Normal diet recommended by the health authorities
LCHF DietOther
LCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Normal diet | Experimental | The group ingests normal diet, recommended by the health authorities Receives: Other: Normal Diet |
| LCHF diet | Experimental | The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat Receives: Other: LCHF Diet |
| Normal diet + exercise | Experimental | The group ingests normal diet, recommended by the health authorities in addition to exercise program 3x week. Receives: Other: Exercise; Other: Normal Diet |
| LCHF diet + exercise | Experimental | The group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat, in addition to exercise program 3x week. Receives: Other: Exercise; Other: LCHF Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) glucose
AUC glucose measured during an OGTT
Measured: Change from baseline AUC glucose at 10 weeks
Secondary outcomes (3)
Lipid profile
Measurements of total cholesterol, LDL, HDL, TG
Measured: Change from Baseline lipids at 10 weeks
Body composition
Measurement of lean body mass, fat free mass, fat mass, visceral fat, bone mass
Measured: Change from baseline values at 10 weeks
Cardiorespiratory fitness
Measurement of peak oxygen uptake
Measured: Change from baseline values at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start21 Jan 2014
- Primary completion4 Apr 2014
- Study completion23 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Diet and exercise, or diet only
- Masking
- None (open label)
- Enrolment
- 57 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
- Jørgen Jensen, Professor, Principal investigator, Norwegian School of Sport Sciences, Section of Physical Performance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100356
- Sponsor's protocol ID
- AMUC-NIH-LCHF-P3-2014
- Status last verified
- Nov 2020
- First submitted
- 13 Sep 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valsdottir TD, Ovrebo B, Kornfeldt TM, Litleskare S, Johansen EI, Henriksen C, Jensen J. Effect of aerobic exercise and low-carbohydrate high-fat diet on glucose tolerance and android/gynoid fat in overweight/obese women: A randomized controlled trial. Front Physiol. 2023 Jan 24;14:1056296. doi: 10.3389/fphys.2023.1056296. eCollection 2023.
PubMed 36760521
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise and/or Diet Body Composition, Cardiorespiratory Fitness and Blood Parameters Related to Improved Health in Overweight Females.
- ClinicalTrials.gov ID
- NCT04100356
- Acronym / sponsor ID
- AMUC-NIH-LCHF-P3-2014
- Conditions
- Overweight and Obesity
- Keywords
- Low-carbohydrate-high-fat diet (LCHF), Low-density-lipoprotein (LDL), High-density-lipoprotein (HDL), Triglycerides (TG), Lipids, Glucose tolerance (GT), Insulin resistance (IR), Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Atlantis Medical University CollegeUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Study start
- 21 Jan 2014 (actual)
- Primary completion
- 4 Apr 2014 (actual)
- Study completion
- 23 Apr 2014 (actual)
- First posted
- 24 Sep 2019 (actual)
- 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.
The study evaluates the effect of exercise and/or diet during on body weight, body composition and health related blood parameters. Participants are overweight sedentary females, allocated to four different groups: Normal diet, Low-carb-high-fat diet, Normal diet + exercise, Low-carb-high-fat diet + exercise.
Detailed description
Diet and exercise can both be efficient tools to reduce bodyweight, get healthier body composition and improve many different health related blood parameters such as cholesterol and glucose tolerance.
Exercise has superior effect on skeletal muscle in the context of glucose tolerance, but adherence to exercise program can be a huge challenge for overweight individuals. While exercise has profound effect on metabolic health, diet has been superior when it comes to weight reduction. Previous studies have shown that 5-7% weight loss can improve glucose tolerance, measured as reduced fasting glucose and reduced 2-hour post prandial glucose.
We wish to see if the combination exercise and diet is superior to diet only when it comes to over all health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Diet and exercise, or diet only
| Arm | Type | Receives |
|---|---|---|
| Normal diet | Experimental | Other: Normal DietThe group ingests normal diet, recommended by the health authorities |
| LCHF diet | Experimental | Other: LCHF DietThe group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat |
| Normal diet + exercise | Experimental | Other: Exercise, Other: Normal DietThe group ingests normal diet, recommended by the health authorities in addition to exercise program 3x week. |
| LCHF diet + exercise | Experimental | Other: Exercise, Other: LCHF DietThe group ingests LCHF diet, a modified Atkins diet with 70 energy percentage fat, in addition to exercise program 3x week. |
Who may qualify
- Ages
- 33 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women
- Sedentary
- Premenopausal
- Caucasian
- BMI 26.9 - 36.1
Key exclusion criteria (9 listed)
- Pregnancy
- Breast-feeding
- Smoking or tobacco use
- Previous medical history of cardio-vascular disease (CVD)
- Previous medical history of diabetes
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 |
|---|---|---|
| ExerciseExercise program - indoor bicycle interval exercise, duration 60 min 3x week | Other | LCHF diet + exercise, Normal diet + exercise |
| Normal DietNormal diet recommended by the health authorities | Other | Normal diet, Normal diet + exercise |
| LCHF DietLCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates | Other | LCHF diet, LCHF diet + exercise |
Primary outcome
Area under curve (AUC) glucose
Time frame: Change from baseline AUC glucose at 10 weeks
AUC glucose measured during an OGTT
3 secondary outcomes
Lipid profile
Time frame: Change from Baseline lipids at 10 weeks
Body composition
Time frame: Change from baseline values at 10 weeks
Cardiorespiratory fitness
Time frame: Change from baseline values at 10 weeks
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 30 Nov 2020.
- Derived from this study: PubMed 36760521Valsdottir TD, Ovrebo B, Kornfeldt TM, Litleskare S, Johansen EI, Henriksen C, Jensen J. Effect of aerobic exercise and low-carbohydrate high-fat diet on glucose tolerance and android/gynoid fat in overweight/obese women: A randomized controlled trial. Front Physiol. 2023 Jan 24;14:1056296. doi: 10.3389/fphys.2023.1056296. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Jørgen Jensen, Professor principal investigator
Norwegian School of Sport Sciences, Section 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 Exercise, Normal Diet and LCHF Diet in people with Overweight and Obesity, 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 7 inclusion and 9 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 30 Nov 2020. 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 curve (AUC) glucose (time frame: Change from baseline AUC glucose at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04100356, which also lists 1 linked publication.
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 30 Nov 2020.