ObesityFATFUNCNCT01750021
Effects of Fat and Carbohydrates in Obese Men
A study testing High fat low carbohydrate diet and Low fat high carbohydrate diet in people with Obesity and Steatosis, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Obesity has become a global epidemic, and treating and preventing obesity appears to be one of the world's greatest challenges. The disorder is associated with a wide range of metabolic and hormonal changes, including the development of insulin resistance, changes in adipose tissue function, increased levels of blood… Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- What is being tested?
- High fat low carbohydrate diet and Low fat high carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2012to Dec 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 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men.
- BMI 30-40.
- Fasting blood glucose < 7 mM.
- Stable body weight last 2 months.
Who cannot join
- High intake of alcohol.
- Medication affecting glucose or lipid metabolism.
- Allergy towards important food items in the diet.
- Inflammatory bowel disease.
- Surgery or use of antibiotics last 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Weight Reducing Diets in Obese Men
Obesity has become a global epidemic, and treating and preventing obesity appears to be one of the world's greatest challenges. The disorder is associated with a wide range of metabolic and hormonal changes, including the development of insulin resistance, changes in adipose tissue function, increased levels of blood lipids, cardiovascular disease and obesity induced fatty liver. Obesity is characterized by inflammation in adipose tissue, altered fat storage capacity and increased exchange of lipids between adipose tissue and blood, and increased secretion of cytokines from adipose tissue. Cytokines are believed to play a central role in the regulation of adipose tissue, the size of adipocytes and other metabolic conditions.
The hepatic synthesis of lipoproteins and interaction with adipose tissue is essential for the body's energy storages. The central role of the liver in energy supply, fat storage and normalization of blood values implies the importance of investigating the interaction between adipose tissue and liver to increase knowledge about the morbidity of obesity. Central obesity and insulin resistance are clear risk factors for the development of fatty liver, but the importance of diet is unclear. The common perception is that fatty liver condition can be improved by a reduction in dietary fat and cholesterols, but the relationship is unclear, and contradictory findings occur in epidemiological studies. It is therefore necessary to better understand the impact of the different macro-nutrients.
The purpose of this study is to determine whether two weight reducing diets with equal calorie levels that contain high or low fat differentially affects the adipose tissue function, distribution of body fat, as well as tissue, blood and urine levels of inflammatory markers, lipids, vitamins, hormones and other substances that may be related to metabolically health.
- Being tested
- High fat low carbohydrate diet, Low fat high carbohydrate diet
- Medical subject headings
- Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat low carbohydrate dietDietary supplement
70E% fat, 20E% protein, 10E% carbohydrates
Low fat high carbohydrate dietDietary supplement
20E% fat, 20E% protein, 60E% carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| High fat low carbohydrate diet | Experimental | High fat low carbohydrate diet Receives: Dietary Supplement: High fat low carbohydrate diet |
| Low fat high carbohydrate diet | Experimental | Low fat high carbohydrate diet Receives: Dietary Supplement: Low fat high carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in adipose tissue
CT, body composition, molecular analyses of adipose tissue
Measured: Baseline and 3 months and 6 months
Secondary outcomes (6)
Changes in metabolic parameters
Molecular and biochemical analyses of tissue, blood and urine
Measured: Baseline and 3 months and 6 months
Changes in inflammatory parameters
Molecular and biochemical analyses of tissue, blood and urine
Measured: Baseline and 3 months and 6 months
Changes in endocrine parameters
Molecular and biochemical analyses of tissue, blood and urine
Measured: Baseline and 3 months and 6 months
Changes in metabolic health
Clinical and biochemical data
Measured: Baseline and 3 months and 6 months
Changes in adipose tissue distribution
Evaluation of adipose tissue distribution by CT
Measured: Baseline and 3 months and 6 months
Changes in steatosis
Evaluation by CT
Measured: Baseline and 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionDec 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 ObesityStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Gunnar Mellgren, MD PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750021
- Sponsor's protocol ID
- 2011/2282
- Acronym
- FATFUNC
- Status last verified
- Nov 2017
- First submitted
- 10 Dec 2012
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Veum VL, Laupsa-Borge J, Eng O, Rostrup E, Larsen TH, Nordrehaug JE, Nygard OK, Sagen JV, Gudbrandsen OA, Dankel SN, Mellgren G. Visceral adiposity and metabolic syndrome after very high-fat and low-fat isocaloric diets: a randomized controlled trial. Am J Clin Nutr. 2017 Jan;105(1):85-99. doi: 10.3945/ajcn.115.123463. Epub 2016 Nov 30.
PubMed 27903520
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Weight Reducing Diets in Obese Men
- ClinicalTrials.gov ID
- NCT01750021
- Acronym / sponsor ID
- FATFUNC / 2011/2282
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Dec 2012 (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.
Obesity has become a global epidemic, and treating and preventing obesity appears to be one of the world's greatest challenges. The disorder is associated with a wide range of metabolic and hormonal changes, including the development of insulin resistance, changes in adipose tissue function, increased levels of blood lipids, cardiovascular disease and obesity induced fatty liver. Obesity is characterized by inflammation in adipose tissue, altered fat storage capacity and increased exchange of lipids between adipose tissue and blood, and increased secretion of cytokines from adipose tissue. Cytokines are believed to play a central role in the regulation of adipose tissue, the size of adipocytes and other metabolic conditions.
The hepatic synthesis of lipoproteins and interaction with adipose tissue is essential for the body's energy storages. The central role of the liver in energy supply, fat storage and normalization of blood values implies the importance of investigating the interaction between adipose tissue and liver to increase knowledge about the morbidity of obesity. Central obesity and insulin resistance are clear risk factors for the development of fatty liver, but the importance of diet is unclear. The common perception is that fatty liver condition can be improved by a reduction in dietary fat and cholesterols, but the relationship is unclear, and contradictory findings occur in epidemiological studies. It is therefore necessary to better understand the impact of the different macro-nutrients.
The purpose of this study is to determine whether two weight reducing diets with equal calorie levels that contain high or low fat differentially affects the adipose tissue function, distribution of body fat, as well as tissue, blood and urine levels of inflammatory markers, lipids, vitamins, hormones and other substances that may be related to metabolically health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat low carbohydrate diet | Experimental | Dietary Supplement: High fat low carbohydrate dietHigh fat low carbohydrate diet |
| Low fat high carbohydrate diet | Experimental | Dietary Supplement: Low fat high carbohydrate dietLow fat high carbohydrate diet |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men.
- BMI 30-40.
- Fasting blood glucose < 7 mM.
- Stable body weight last 2 months.
Key exclusion criteria (5 listed)
- High intake of alcohol.
- Medication affecting glucose or lipid metabolism.
- Allergy towards important food items in the diet.
- Inflammatory bowel disease.
- Surgery or use of antibiotics last 2 months.
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 |
|---|---|---|
| High fat low carbohydrate diet70E% fat, 20E% protein, 10E% carbohydrates | Dietary supplement | High fat low carbohydrate diet |
| Low fat high carbohydrate diet20E% fat, 20E% protein, 60E% carbohydrates | Dietary supplement | Low fat high carbohydrate diet |
Primary outcome
Changes in adipose tissue
Time frame: Baseline and 3 months and 6 months
CT, body composition, molecular analyses of adipose tissue
6 secondary outcomes
Changes in metabolic parameters
Time frame: Baseline and 3 months and 6 months
Changes in inflammatory parameters
Time frame: Baseline and 3 months and 6 months
Changes in endocrine parameters
Time frame: Baseline and 3 months and 6 months
Changes in metabolic health
Time frame: Baseline and 3 months and 6 months
Changes in adipose tissue distribution
Time frame: Baseline and 3 months and 6 months
Changes in steatosis
Time frame: Baseline and 3 months and 6 months
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 2017.
- Results publication: PubMed 27903520Veum VL, Laupsa-Borge J, Eng O, Rostrup E, Larsen TH, Nordrehaug JE, Nygard OK, Sagen JV, Gudbrandsen OA, Dankel SN, Mellgren G. Visceral adiposity and metabolic syndrome after very high-fat and low-fat isocaloric diets: a randomized controlled trial. Am J Clin Nutr. 2017 Jan;105(1):85-99. doi: 10.3945/ajcn.115.123463. Epub 2016 Nov 30.
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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.
Gunnar Mellgren, MD PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fat low carbohydrate diet and Low fat high carbohydrate diet in people with Obesity and Steatosis, run by Haukeland University Hospital 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 5 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 2017. 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?
Changes in adipose tissue (time frame: Baseline and 3 months and 6 months). 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 NCT01750021, 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 2017.