ObesityNCT00230919
Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Diet Compared With a Standard Diet
A study testing Diet counseling in people with Obesity and Metabolic Syndrome, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
Overweight and obesity is increasing in most countries, including Norway, and the optimal diet for reducing weight is under discussion. The present study in overweight and moderate obese individuals compares a low glycemic load diet with a standard low-fat diet (as recommended from the National Nutrition Council) in… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Diet counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2004to Nov 2006
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women age 30-65,
- BMI in the range 28-35 kg/m2 for women and 28-40kg/m2 for men.
- At least one of the following components of the metabolic syndrome; fasting triglycerides > 1,7, fasting glucose 6,0-6,9, HDL-cholesterol <1,03 (males) or <1,29 (females), Blood pressure >130/85 (with or without treatment), diet-treated diabetes mellitus or drug treated hypertension.
- Stable weight range of 4 kg or less the last 12 weeks,
- No major change in physical activity the last 12 weeks
Who cannot join
- Any symptomatic cardiovascular disease
- Diabetes requiring drug treatment
- Currently on special diet
- Hepatic/renal dysfunction
- Hypothyroidism (unstable)
- GI disorder impairing compliance with diet recommendation,
Show all 16Show fewer
- History of unstable psychiatric or medical disorder,
- Need of lipid lowering drug,
- Alcohol or drug abuse,
- Participation in drug trial the last 30 days,
- Use of drugs for weight reduction last 12 weeks, pregnancy or planned pregnancy,
- Obesity of known endocrine origin, history of obesity surgery,
- Uncontrolled hypertension (>160/100),
- Previous participation in >3 weight reduction programs, or within last 12 months,
- Not willing to be randomized,
- Individual judged to be unable to follow instructions and procedures of the study
Trial locations and contacts
1 site in 1 country.
Norway1 site
Ulleval University Hospital, dep. of preventive cardiology
Oslo, Oslo, N-0407
About this study
Official title: Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Load Diet Compared With a Standard National Nutrition Council-recommended Diet: a Randomized Trial
Overweight and obesity is increasing in most countries, including Norway, and the optimal diet for reducing weight is under discussion. The present study in overweight and moderate obese individuals compares a low glycemic load diet with a standard low-fat diet (as recommended from the National Nutrition Council) in an open, randomized trial over 12 months, with changes in weight loss and changes in cardiovascular risk markers as endpoints.
Read the detailed description
Overweight and obesity is rapidly increasing in most countries, including Norway, and at present there is controversy regarding what diet should be recommended for reducing weight and the complications of obesity.
The present study is performed in in 200 overweight and moderate obese individuals, that is in men with body mass index (BMI) from 28 to 40, and women with BMI 28-35. To be included, the participants should also have at least one component of the metabolic syndrome.
After a medical examination and check for inclusion and exclusion criteria, the participants are randomized to one the two following diets: 1) A low-glycemic load diet aiming at a macronutrient composition with 25-30% of energy from protein, 35-40% from fat and 30-35% from carbohydrate or 2) A low-fat diet aiming at a macronutrient composition with 15% of energy from protein, 25-30% from fat and 55-60% from carbohydrate.
Each group will have 9 dietary counselling sessions in the course of the study; baseline, week 2, month 1,3,4,5,6 and 9. Recommended total energy intake will be individualized based on the metabolic rate at rest for each subject, and using a physical activity level of 1,4. A 500 kcal/day deficit relative to the daily energy requirements will be recommended.
The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
As secondary objectives the study will compare the consequences of the two strategies with respect to 3, 6, and 12 months development of the variables glucose/insulin, insulin sensitivity index, number of metabolic syndrome factors, high sensitive C-reactive protein, lipids, lipoprotein B and anthropometric indices (waist /hip ratio). Serum will be frozen for additional parameters as leptin, adiponectin, ghrelin and ICAM. Also to be studied is an additional weight at 18 months follow-up, when no more advice is given past the 9-month visit.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Diet counseling
- Keywords
- Obesity,, weight loss,, diet counseling, low-glycemic load
- Medical subject headings
- Obesity, Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet counselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
Secondary outcomes (9)
Compare the consequences of the two strategies with respect to 3, 6, and 12 months development of the variables; glucose/insulin,
insulin sensitivity index,
number of metabolic syndrome factors,
high sensitive C-reactive protein,
lipids and lipoprotein B and
anthropometric indices (waist /hip ratio)
Fat cell hormones (leptin, adiponectin, ghrelin)
Inflammation markers (ICAM).
Weight at 18 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startApr 2004
- Primary completionJun 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway
- Investigators
- Tor Ole Klemsdal, MD, Ph.D, Principal investigator, Ullevaal University Hospital, preventive medicine clinicSerena Tonstad, MD, Ph.D, Study chair, Ullevaal University Hospital, preventive medicine clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230919
- Sponsor's protocol ID
- 161327/V50
- Status last verified
- Feb 2004
- First submitted
- 30 Sep 2005
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Klemsdal TO, Holme I, Nerland H, Pedersen TR, Tonstad S. Effects of a low glycemic load diet versus a low-fat diet in subjects with and without the metabolic syndrome. Nutr Metab Cardiovasc Dis. 2010 Mar;20(3):195-201. doi: 10.1016/j.numecd.2009.03.010. Epub 2009 Jun 6.
PubMed 19502017Heggen E, Klemsdal TO, Haugen F, Holme I, Tonstad S. Effect of a low-fat versus a low-gycemic-load diet on inflammatory biomarker and adipokine concentrations. Metab Syndr Relat Disord. 2012 Dec;10(6):437-42. doi: 10.1089/met.2012.0012. Epub 2012 Aug 13.
PubMed 22889406
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Load Diet Compared With a Standard National Nutrition Council-recommended Diet: a Randomized Trial
- ClinicalTrials.gov ID
- NCT00230919
- Acronym / sponsor ID
- 161327/V50
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- Obesity,, weight loss,, diet counseling, low-glycemic load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway
- Study start
- Apr 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 3 Oct 2005 (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.
Overweight and obesity is increasing in most countries, including Norway, and the optimal diet for reducing weight is under discussion. The present study in overweight and moderate obese individuals compares a low glycemic load diet with a standard low-fat diet (as recommended from the National Nutrition Council) in an open, randomized trial over 12 months, with changes in weight loss and changes in cardiovascular risk markers as endpoints.
Detailed description
Overweight and obesity is rapidly increasing in most countries, including Norway, and at present there is controversy regarding what diet should be recommended for reducing weight and the complications of obesity.
The present study is performed in in 200 overweight and moderate obese individuals, that is in men with body mass index (BMI) from 28 to 40, and women with BMI 28-35. To be included, the participants should also have at least one component of the metabolic syndrome.
After a medical examination and check for inclusion and exclusion criteria, the participants are randomized to one the two following diets: 1) A low-glycemic load diet aiming at a macronutrient composition with 25-30% of energy from protein, 35-40% from fat and 30-35% from carbohydrate or 2) A low-fat diet aiming at a macronutrient composition with 15% of energy from protein, 25-30% from fat and 55-60% from carbohydrate.
Each group will have 9 dietary counselling sessions in the course of the study; baseline, week 2, month 1,3,4,5,6 and 9. Recommended total energy intake will be individualized based on the metabolic rate at rest for each subject, and using a physical activity level of 1,4. A 500 kcal/day deficit relative to the daily energy requirements will be recommended.
The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
As secondary objectives the study will compare the consequences of the two strategies with respect to 3, 6, and 12 months development of the variables glucose/insulin, insulin sensitivity index, number of metabolic syndrome factors, high sensitive C-reactive protein, lipids, lipoprotein B and anthropometric indices (waist /hip ratio). Serum will be frozen for additional parameters as leptin, adiponectin, ghrelin and ICAM. Also to be studied is an additional weight at 18 months follow-up, when no more advice is given past the 9-month visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women age 30-65,
- BMI in the range 28-35 kg/m2 for women and 28-40kg/m2 for men.
- At least one of the following components of the metabolic syndrome; fasting triglycerides > 1,7, fasting glucose 6,0-6,9, HDL-cholesterol <1,03 (males) or <1,29 (females), Blood pressure >130/85 (with or without treatment), diet-treated diabetes mellitus or drug treated hypertension.
- Stable weight range of 4 kg or less the last 12 weeks,
- No major change in physical activity the last 12 weeks
Key exclusion criteria (16 listed)
- Any symptomatic cardiovascular disease
- Diabetes requiring drug treatment
- Currently on special diet
- Hepatic/renal dysfunction
- Hypothyroidism (unstable)
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 |
|---|---|---|
| Diet counseling | Behavioural | – |
Primary outcome
The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
9 secondary outcomes
Compare the consequences of the two strategies with respect to 3, 6, and 12 months development of the variables; glucose/insulin,
insulin sensitivity index,
number of metabolic syndrome factors,
high sensitive C-reactive protein,
lipids and lipoprotein B and
anthropometric indices (waist /hip ratio)
Fat cell hormones (leptin, adiponectin, ghrelin)
Inflammation markers (ICAM).
Weight at 18 months follow-up.
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 1 Jul 2011.
- Results publication: PubMed 19502017Klemsdal TO, Holme I, Nerland H, Pedersen TR, Tonstad S. Effects of a low glycemic load diet versus a low-fat diet in subjects with and without the metabolic syndrome. Nutr Metab Cardiovasc Dis. 2010 Mar;20(3):195-201. doi: 10.1016/j.numecd.2009.03.010. Epub 2009 Jun 6.
- Derived from this study: PubMed 22889406Heggen E, Klemsdal TO, Haugen F, Holme I, Tonstad S. Effect of a low-fat versus a low-gycemic-load diet on inflammatory biomarker and adipokine concentrations. Metab Syndr Relat Disord. 2012 Dec;10(6):437-42. doi: 10.1089/met.2012.0012. Epub 2012 Aug 13.
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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.
Tor Ole Klemsdal, MD, Ph.D principal investigator
Ullevaal University Hospital, preventive medicine clinic
Serena Tonstad, MD, Ph.D study chair
Ullevaal University Hospital, preventive medicine clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet counseling in people with Obesity and Metabolic Syndrome, run by Ullevaal 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 5 inclusion and 16 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 1 Jul 2011. 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?
The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.. 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 NCT00230919, which also lists 2 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 1 Jul 2011.