ObesityKNOTANCT00692536
Diet Composition - Metabolic Regulation and Long-term Compliance
A study testing NNR (Nordic Nutrition Recommendations) and MPD (Modified paleolithic diet) in people with Obesity, run by Umeå University at 1 site in Sweden.
Trial summary
This study will compare a high-protein/low-carbohydrate diet (modified paleolithic diet, MPD) with a diet high in slow carbohydrates (Nordic Nutrition Recommendations, NNR). The diets will be compared with respect effects on weight reduction, metabolic regulation, and long-term compliance to the diet regimes. Read more about this study
- Who is it for?
- Ages Up to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- NNR (Nordic Nutrition Recommendations) and MPD (Modified paleolithic diet)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to Jun 2010
- 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 Up to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female
- Postmenopausal
- BMI>28
Who cannot join
- Disease
- Gravidity
- Smoking
- Prescribed medication
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare a high-protein/low-carbohydrate diet (modified paleolithic diet, MPD) with a diet high in slow carbohydrates (Nordic Nutrition Recommendations, NNR). The diets will be compared with respect effects on weight reduction, metabolic regulation, and long-term compliance to the diet regimes. Seventy-two postmenopausal overweight healthy women have been recruited and will be followed for two years.
The following variables will be studied:
- Anthropometry
- DEXA
- OGTT
- Liver fat content measured with 1H-MRS
- Hepatic 11β-HSD1 activity, measured with cortisone/cortisol conversion test
- Conditions
- Obesity
- Being tested
- NNR (Nordic Nutrition Recommendations), MPD (Modified paleolithic diet)
- Keywords
- Obesity, Postmenopausal, Diet intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNR (Nordic Nutrition Recommendations)Behavioural
Also called Nordic Nutrition recommendations
Diet with equal amounts of fat, protein and carbohydrates
MPD (Modified paleolithic diet)Behavioural
Also called Modified paleolithic diet
A diet high in protein and fat, but low in carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | NNR Receives: Behavioral: NNR (Nordic Nutrition Recommendations) |
| 2 | Active comparator | MPD Receives: Behavioral: MPD (Modified paleolithic diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat
Measured: Sept 2008
Secondary outcomes (2)
Body weight
Measured: Sept 2008
Apnea-Hypopnea Index (AHI)
Measured: Sept 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mats Ryberg, Umeå University
- Investigators
- Mats Ryberg, PhD, MD, Principal investigator, Umeå University, Umeå, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692536
- Sponsor's protocol ID
- Um dnr 07-034M
- Acronym
- KNOTA
- Status last verified
- Sep 2015
- First submitted
- 4 Jun 2008
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Franklin KA, Lindberg E, Svensson J, Larsson C, Lindahl B, Mellberg C, Sahlin C, Olsson T, Ryberg M. Effects of a palaeolithic diet on obstructive sleep apnoea occurring in females who are overweight after menopause-a randomised controlled trial. Int J Obes (Lond). 2022 Oct;46(10):1833-1839. doi: 10.1038/s41366-022-01182-4. Epub 2022 Jul 25.
PubMed 35879528Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 Aug 21;8(8):CD011737. doi: 10.1002/14651858.CD011737.pub3.
PubMed 32827219Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.
PubMed 32428300Manousou S, Stal M, Larsson C, Mellberg C, Lindahl B, Eggertsen R, Hulthen L, Olsson T, Ryberg M, Sandberg S, Nystrom HF. A Paleolithic-type diet results in iodine deficiency: a 2-year randomized trial in postmenopausal obese women. Eur J Clin Nutr. 2018 Jan;72(1):124-129. doi: 10.1038/ejcn.2017.134. Epub 2017 Sep 13.
PubMed 28901333Blomquist C, Alvehus M, Buren J, Ryberg M, Larsson C, Lindahl B, Mellberg C, Soderstrom I, Chorell E, Olsson T. Attenuated Low-Grade Inflammation Following Long-Term Dietary Intervention in Postmenopausal Women with Obesity. Obesity (Silver Spring). 2017 May;25(5):892-900. doi: 10.1002/oby.21815.
PubMed 28440046Boraxbekk CJ, Stomby A, Ryberg M, Lindahl B, Larsson C, Nyberg L, Olsson T. Diet-Induced Weight Loss Alters Functional Brain Responses during an Episodic Memory Task. Obes Facts. 2015;8(4):261-72. doi: 10.1159/000437157. Epub 2015 Jul 1.
PubMed 26139105Hammarstrom A, Wiklund AF, Lindahl B, Larsson C, Ahlgren C. Experiences of barriers and facilitators to weight-loss in a diet intervention - a qualitative study of women in northern Sweden. BMC Womens Health. 2014 Apr 16;14:59. doi: 10.1186/1472-6874-14-59.
PubMed 24739099
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Composition - Metabolic Regulation and Long-term Compliance
- ClinicalTrials.gov ID
- NCT00692536
- Acronym / sponsor ID
- KNOTA / Um dnr 07-034M
- Conditions
- Obesity
- Keywords
- Obesity, Postmenopausal, Diet intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Jun 2008 (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.
This study will compare a high-protein/low-carbohydrate diet (modified paleolithic diet, MPD) with a diet high in slow carbohydrates (Nordic Nutrition Recommendations, NNR). The diets will be compared with respect effects on weight reduction, metabolic regulation, and long-term compliance to the diet regimes. Seventy-two postmenopausal overweight healthy women have been recruited and will be followed for two years.
The following variables will be studied:
- Anthropometry
- DEXA
- OGTT
- Liver fat content measured with 1H-MRS
- Hepatic 11β-HSD1 activity, measured with cortisone/cortisol conversion test
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: NNR (Nordic Nutrition Recommendations)NNR |
| 2 | Active comparator | Behavioral: MPD (Modified paleolithic diet)MPD |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Postmenopausal
- BMI>28
Key exclusion criteria (4 listed)
- Disease
- Gravidity
- Smoking
- Prescribed medication
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 |
|---|---|---|
| NNR (Nordic Nutrition Recommendations)Also: Nordic Nutrition recommendationsDiet with equal amounts of fat, protein and carbohydrates | Behavioural | 1 |
| MPD (Modified paleolithic diet)Also: Modified paleolithic dietA diet high in protein and fat, but low in carbohydrates | Behavioural | 2 |
Primary outcome
Liver fat
Time frame: Sept 2008
2 secondary outcomes
Body weight
Time frame: Sept 2008
Apnea-Hypopnea Index (AHI)
Time frame: Sept 2008
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 3 Sep 2015.
- Derived from this study: PubMed 35879528Franklin KA, Lindberg E, Svensson J, Larsson C, Lindahl B, Mellberg C, Sahlin C, Olsson T, Ryberg M. Effects of a palaeolithic diet on obstructive sleep apnoea occurring in females who are overweight after menopause-a randomised controlled trial. Int J Obes (Lond). 2022 Oct;46(10):1833-1839. doi: 10.1038/s41366-022-01182-4. Epub 2022 Jul 25.
- Derived from this study: PubMed 32827219Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 Aug 21;8(8):CD011737. doi: 10.1002/14651858.CD011737.pub3.
- Derived from this study: PubMed 32428300Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.
- Derived from this study: PubMed 28901333Manousou S, Stal M, Larsson C, Mellberg C, Lindahl B, Eggertsen R, Hulthen L, Olsson T, Ryberg M, Sandberg S, Nystrom HF. A Paleolithic-type diet results in iodine deficiency: a 2-year randomized trial in postmenopausal obese women. Eur J Clin Nutr. 2018 Jan;72(1):124-129. doi: 10.1038/ejcn.2017.134. Epub 2017 Sep 13.
- Derived from this study: PubMed 28440046Blomquist C, Alvehus M, Buren J, Ryberg M, Larsson C, Lindahl B, Mellberg C, Soderstrom I, Chorell E, Olsson T. Attenuated Low-Grade Inflammation Following Long-Term Dietary Intervention in Postmenopausal Women with Obesity. Obesity (Silver Spring). 2017 May;25(5):892-900. doi: 10.1002/oby.21815.
- Derived from this study: PubMed 26139105Boraxbekk CJ, Stomby A, Ryberg M, Lindahl B, Larsson C, Nyberg L, Olsson T. Diet-Induced Weight Loss Alters Functional Brain Responses during an Episodic Memory Task. Obes Facts. 2015;8(4):261-72. doi: 10.1159/000437157. Epub 2015 Jul 1.
- Derived from this study: PubMed 24739099Hammarstrom A, Wiklund AF, Lindahl B, Larsson C, Ahlgren C. Experiences of barriers and facilitators to weight-loss in a diet intervention - a qualitative study of women in northern Sweden. BMC Womens Health. 2014 Apr 16;14:59. doi: 10.1186/1472-6874-14-59.
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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.
Mats Ryberg, PhD, MD principal investigator
Umeå University, Umeå, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NNR (Nordic Nutrition Recommendations) and MPD (Modified paleolithic diet) in people with Obesity, run by Umeå University at 1 site in Sweden.
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 3 inclusion and 4 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 3 Sep 2015. 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 Sweden. 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?
Liver fat (time frame: Sept 2008). 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 NCT00692536, which also lists 7 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 3 Sep 2015.