OverweightNCT00274729
Mono Unsaturated Fatty Acids in Obesity - Weight Maintenance and Prevention of Lifestyle Diseases in Obese Subjects.
A study testing Mono Unsaturated Fatty Acids in Obesity in people with Overweight and Obesity, run by University of Copenhagen.
Trial summary
The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Mono Unsaturated Fatty Acids in Obesity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jun 2008
- 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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 16-35 years
- Body mass index (kg/m2): 28-36
Who cannot join
- Body weight fluctuations > 3 kg over the previous 2 months
- Smoking
- Presence of:
- Cardiovascular diseases, cancer tumours, kidney or lever diseases, infections or endocrinological diseases, malabsorption disorders
- Systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg
- Hypercholesterolemia with changes in pharmacological treatment within the last 2 months
- Regular use of medicine other than birth pills, any psychological disorders, known or presumed abuse of alcohol, allergies to any food, special diets (eg. vegetarian) or particular dislikes
- Pregnancy, lactating or planning pregnancy within 18 month from enrolment
About this study
Official title: MUFObes: MonoUnsaturated Fatty Acids in Obesity - a Comparison Between 3 Different Diets in Weight Maintenance and the Prevention of Lifestyle Diseases in Obese Subjects. A Randomised, Long-term Intervention Study.
The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.
Read the detailed description
The obesity epidemic has raised concerns, because of complications such as type 2 diabetes, cardiovascular disease and certain types of cancer. Much conflict and confusion about the optimal diet for weight control exists among the public.
The current dietary recommendations aim at reducing the total fat in the diet to less than 30% of calories, increasing carbohydrates to 55-60%, and protein from lean meat and dairy products to 15-20%, and to keep the intake of sugar sweetened soft-drinks limited. There is good evidence from meta-analyses of intervention studies that a low fat diet can prevent weight gain in normal weight individuals, induce a small but clinically relevant weight loss in overweight individuals, and also reduce the risk of cardiovascular disease and type 2 diabetes.
However this recommended diet may not be of the optimal composition in preventing the progressive increase in obesity and lifestyle diseases. The traditional dietary recommendation has been challenged by the epidemiologist Walter Willett, Harvard Medical School in Boston. He claims that dietary fat is less important for the development of obesity, and that the fat content of the diet can be 40-45% of the energy providing from mainly mono- and polyunsaturated fatty acids. Based on mainly large-scale observational studies ('Nurses Health Study') he has developed new dietary guidelines, expressed as a new diet pyramid. In contrast to the current guidelines, more plant oils and plant foods, limited animal products, such as meat and dairy products (even lean products), and increased intake of olive oil, nuts, etc., e.g. guidelines closer to the "Mediterranean Diet".
There is circumstantial evidence to support that this moderate fat, MUFA-rich diet will have a beneficial effect on some of the traditional risk factors for cardiovascular disease and type-2 diabetes. However, there is also growing concern that the increased total fat content will lead to weight gain and increased risk of obesity, and secondary to this, type-2 diabetes and cardiovascular disease. This debate has now been taken up by some of the finest scientific journals. To test this hypothesis the largest and longest dietary intervention trial in Denmark is carried out at the Department of Human Nutrition.
The objective is to identify the diet and diet components most effective for protection against weight gain, weight regain and prevention of life-style diseases in obese subjects. The three diets tested are according to:
- Willetts new dietary recommendations. High in mono unsaturated fat and low in glycemic index (50 subjects).
- The traditional dietary recommendations. Low in fat and medium in glycemic index (50 subjects).
- The average Danish diet (Control). High in fat and high in glycemic index (25 subjects).
The diets are ad libitum (i.e. no restriction in calorie intake), but very strict in dietary composition.
- Conditions
- Overweight, Obesity
- Being tested
- Mono Unsaturated Fatty Acids in Obesity
- Keywords
- Dietary intervention, High-carbohydrate diet, High-fat diet, Moderate-fat diet, Obesity, Weight maintenance, Body composition, Glucose metabolism, Cardiovascular disease, Appetite regulation, Energy expenditure
- Medical subject headings
- Overweight, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mono Unsaturated Fatty Acids in ObesityBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
Weight loss maintenance efficacy (>5% and >10%)
Body composition (whole body DEXA-scanning)
Drop-out rate
Glucose metabolism (Oral Glucose Tolerance Test)
Endothelium function (flow-mediated vasodilatation, FMD)
Secondary outcomes (13)
Changes in:
Blood lipids
Blood glucose
HbA1c
Insulin
Blood coagulation factors
Waist
Waist/hip-ratio
Blood pressure
Appetite & diet palatability
Appetite regulating hormones (during meal test)
Visual analogue scale (VAS) (during meal test)
Energy expenditure (24 hour whole body indirect calorimetry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startJan 2004
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, University Hospital, Gentofte, Copenhagen, Copenhagen University Hospital, Rigshospitalet, Technical University of Denmark, Harvard School of Public Health (HSPH), Boston Children's Hospital, Danish Meat Research Institute, Danisco, The Danish Dairy Research Foundation, Denmark, Various FOOD sponsors have provided groceries for the dietary intervention
- Investigators
- Arne Astrup, MD DMSC, Principal investigator, Department of Human Nutrition, The Royal Veterinary & Agricultural University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274729
- Sponsor's protocol ID
- KF 01-172/03
- Status last verified
- Jan 2006
- First submitted
- 10 Jan 2006
- Last updated
- 25 Mar 2010
- Results posted
- No
Publications
Hjorth MF, Due A, Larsen TM, Astrup A. Pretreatment Fasting Plasma Glucose Modifies Dietary Weight Loss Maintenance Success: Results from a Stratified RCT. Obesity (Silver Spring). 2017 Dec;25(12):2045-2048. doi: 10.1002/oby.22004. Epub 2017 Oct 6.
PubMed 28985039Due A, Larsen TM, Mu H, Hermansen K, Stender S, Astrup A. Comparison of 3 ad libitum diets for weight-loss maintenance, risk of cardiovascular disease, and diabetes: a 6-mo randomized, controlled trial. Am J Clin Nutr. 2008 Nov;88(5):1232-41. doi: 10.3945/ajcn.2007.25695.
PubMed 18996857Due A, Larsen TM, Hermansen K, Stender S, Holst JJ, Toubro S, Martinussen T, Astrup A. Comparison of the effects on insulin resistance and glucose tolerance of 6-mo high-monounsaturated-fat, low-fat, and control diets. Am J Clin Nutr. 2008 Apr;87(4):855-62. doi: 10.1093/ajcn/87.4.855.
PubMed 18400707
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUFObes: MonoUnsaturated Fatty Acids in Obesity - a Comparison Between 3 Different Diets in Weight Maintenance and the Prevention of Lifestyle Diseases in Obese Subjects. A Randomised, Long-term Intervention Study.
- ClinicalTrials.gov ID
- NCT00274729
- Acronym / sponsor ID
- KF 01-172/03
- Conditions
- Overweight, Obesity
- Keywords
- Dietary intervention, High-carbohydrate diet, High-fat diet, Moderate-fat diet, Obesity, Weight maintenance, Body composition, Glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University Hospital, Gentofte, Copenhagen, Copenhagen University Hospital, Rigshospitalet, Technical University of Denmark, Harvard School of Public Health (HSPH), Boston Children's Hospital, Danish Meat Research Institute, Danisco, The Danish Dairy Research Foundation, Denmark, Various FOOD sponsors have provided groceries for the dietary intervention
- Study start
- Jan 2004
- Study completion
- Jun 2008
- First posted
- 11 Jan 2006 (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.
The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.
Detailed description
The obesity epidemic has raised concerns, because of complications such as type 2 diabetes, cardiovascular disease and certain types of cancer. Much conflict and confusion about the optimal diet for weight control exists among the public.
The current dietary recommendations aim at reducing the total fat in the diet to less than 30% of calories, increasing carbohydrates to 55-60%, and protein from lean meat and dairy products to 15-20%, and to keep the intake of sugar sweetened soft-drinks limited. There is good evidence from meta-analyses of intervention studies that a low fat diet can prevent weight gain in normal weight individuals, induce a small but clinically relevant weight loss in overweight individuals, and also reduce the risk of cardiovascular disease and type 2 diabetes.
However this recommended diet may not be of the optimal composition in preventing the progressive increase in obesity and lifestyle diseases. The traditional dietary recommendation has been challenged by the epidemiologist Walter Willett, Harvard Medical School in Boston. He claims that dietary fat is less important for the development of obesity, and that the fat content of the diet can be 40-45% of the energy providing from mainly mono- and polyunsaturated fatty acids. Based on mainly large-scale observational studies ('Nurses Health Study') he has developed new dietary guidelines, expressed as a new diet pyramid. In contrast to the current guidelines, more plant oils and plant foods, limited animal products, such as meat and dairy products (even lean products), and increased intake of olive oil, nuts, etc., e.g. guidelines closer to the "Mediterranean Diet".
There is circumstantial evidence to support that this moderate fat, MUFA-rich diet will have a beneficial effect on some of the traditional risk factors for cardiovascular disease and type-2 diabetes. However, there is also growing concern that the increased total fat content will lead to weight gain and increased risk of obesity, and secondary to this, type-2 diabetes and cardiovascular disease. This debate has now been taken up by some of the finest scientific journals. To test this hypothesis the largest and longest dietary intervention trial in Denmark is carried out at the Department of Human Nutrition.
The objective is to identify the diet and diet components most effective for protection against weight gain, weight regain and prevention of life-style diseases in obese subjects. The three diets tested are according to:
- Willetts new dietary recommendations. High in mono unsaturated fat and low in glycemic index (50 subjects).
- The traditional dietary recommendations. Low in fat and medium in glycemic index (50 subjects).
- The average Danish diet (Control). High in fat and high in glycemic index (25 subjects).
The diets are ad libitum (i.e. no restriction in calorie intake), but very strict in dietary composition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age: 16-35 years
- Body mass index (kg/m2): 28-36
Key exclusion criteria (8 listed)
- Body weight fluctuations > 3 kg over the previous 2 months
- Smoking
- Cardiovascular diseases, cancer tumours, kidney or lever diseases, infections or endocrinological diseases, malabsorption disorders
- Systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg
- Hypercholesterolemia with changes in pharmacological treatment within the 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 |
|---|---|---|
| Mono Unsaturated Fatty Acids in Obesity | Behavioural | – |
Primary outcome
Changes in body weight
Weight loss maintenance efficacy (>5% and >10%)
Body composition (whole body DEXA-scanning)
Drop-out rate
Glucose metabolism (Oral Glucose Tolerance Test)
Endothelium function (flow-mediated vasodilatation, FMD)
13 secondary outcomes
Changes in:
Blood lipids
Blood glucose
HbA1c
Insulin
Blood coagulation factors
Waist
Waist/hip-ratio
Blood pressure
Appetite & diet palatability
Appetite regulating hormones (during meal test)
Visual analogue scale (VAS) (during meal test)
Energy expenditure (24 hour whole body indirect calorimetry)
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 25 Mar 2010.
- Derived from this study: PubMed 28985039Hjorth MF, Due A, Larsen TM, Astrup A. Pretreatment Fasting Plasma Glucose Modifies Dietary Weight Loss Maintenance Success: Results from a Stratified RCT. Obesity (Silver Spring). 2017 Dec;25(12):2045-2048. doi: 10.1002/oby.22004. Epub 2017 Oct 6.
- Derived from this study: PubMed 18996857Due A, Larsen TM, Mu H, Hermansen K, Stender S, Astrup A. Comparison of 3 ad libitum diets for weight-loss maintenance, risk of cardiovascular disease, and diabetes: a 6-mo randomized, controlled trial. Am J Clin Nutr. 2008 Nov;88(5):1232-41. doi: 10.3945/ajcn.2007.25695.
- Derived from this study: PubMed 18400707Due A, Larsen TM, Hermansen K, Stender S, Holst JJ, Toubro S, Martinussen T, Astrup A. Comparison of the effects on insulin resistance and glucose tolerance of 6-mo high-monounsaturated-fat, low-fat, and control diets. Am J Clin Nutr. 2008 Apr;87(4):855-62. doi: 10.1093/ajcn/87.4.855.
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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.
Arne Astrup, MD DMSC principal investigator
Department of Human Nutrition, The Royal Veterinary & Agricultural University
Questions about this trial
What is this clinical trial studying?
A study testing Mono Unsaturated Fatty Acids in Obesity in people with Overweight and Obesity, run by University of Copenhagen.
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 2 inclusion and 8 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 25 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
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 body weight. The study lists 6 primary outcomes in all. 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 NCT00274729, which also lists 3 linked publications.
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 25 Mar 2010.