Abdominal ObesityPhase 2/3GETNCT01208558
Grain Exercise Trial - Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss
A Phase 2/3 study testing Diet A, Diet B and Physiotherapy in people with Abdominal Obesity and Cardiovascular Diseases, run by Lund University at 1 site in Sweden.
Trial summary
The main purpose of this 2-year lifestyle experiment for waist loss is twofold: 1. to compare whole grains and no grains as part of a healthy diet, 2. to determine if an 8-week exercise program, led by physiotherapists, is more efficient than brief counseling and follow-up. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity, Cardiovascular Diseases, Diabetes Type 2
- What is being tested?
- Diet A, Diet B and Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2010to Nov 2014
- Phase
- Phase 2/3
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- increased waist circumference (≥84 cm in women and ≥98 cm in men)
- AND at least one additional cardiovascular risk factor: hypertension, diabetes type 2, prior coronary heart disease, prior stroke/TIA, peripheral arterial disease, impaired glucose tolerance, prior gestational diabetes, heredity or smoking
Who cannot join
- dependence on walking aids
- difficulty to understand Swedish (written or spoken)
- BMI >40 kg/m2
- cognitive impairment
- pronounced hearing loss
- aphasia
- continuous treatment with warfarin or prednisolone
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Center for Primary Health Care Research, CRC, Lund University, Sweden
Lund, Skåne County
About this study
Official title: Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss
The main purpose of this 2-year lifestyle experiment for waist loss is twofold:
- to compare whole grains and no grains as part of a healthy diet,
- to determine if an 8-week exercise program, led by physiotherapists, is more efficient than brief counseling and follow-up.
People with abdominal overweight (≥84 cm in women and ≥98 cm in men) and at least one additional cardiovascular risk factor, (typically hypertension, diabetes type 2 or prior cardiovascular disease) are randomly assigned to receive Diet A or Diet B, with or without a structured exercise program at the department of physiotherapy, or to a control group receiving usual care. Diet A and B both include fruit, vegetables, fish, meat, and low-fat dairy products, and differ only in that Diet A recommends exchange of cereal grains for more potatoes, root vegetables, fruit and other carbohydrate-rich foods, while Diet B recommends exchange of regular cereal grains for whole grains. The primary outcome (most important follow-up variable) is change in waist circumference during 2 years. Secondary outcome measures include blood pressure, blood lipids, level of physical activity and, in subjects with diabetes, glycated hemoglobin and fasting blood sugar.
Read the detailed description
This is a randomized controlled trial with 5 parallel groups of approximately equal size. Two hundred subjects with increased waist circumference (≥84 cm in women and ≥98 cm in men) and at least one additional cardiovascular risk factor will be included.
Four of the 5 groups will receive dietary advice (A or B) and 2 of them will be allocated to physiotherapy. A fifth control group will only receive usual care in addition to follow-up. Randomization will be performed by use of an internet-based random number generator from the School of Computer Science and Statistics, Trinity College, Dublin (www.random.org). randomly assigned to receive Diet A or Diet B, with or without a structured exercise program at the department of physiotherapy, or to a control group receiving usual care.
In addition to primary (waist loss) and secondary outcome measures as given below, a health questionnaire will be performed at baseline and after 12 and 24 months with questions about general health, self-reported quality of life, medication use, living habits, physical activity, nutrition, tobacco, alcohol, personal motivation and perceived ability to change lifestyle. Furthermore, serum creatinine will be measured at baseline, and after 3, 6, 12 and 24 months.
There are few randomized controlled trials comparing the effect of different lifestyle interventions on physical activity level or weight loss in overweight people at high risk of cardiovascular disease. There is no such study of the possible effect of a structured exercise program with group training led by physiotherapists, with the exception of rehabilitation programs after myocardial infarction. In addition, the possible unique effect of cereal grains on satiety and energy intake has not been addressed in randomized controlled trials. In two earlier studies in glucose intolerance and diabetes type 2, we have applied a dietary model (Paleolithic diet) based on root vegetables, fruit, vegetables, meat and fish, partly at the expense of cereal grains (Lindeberg et al., 2007; Jönsson et al., 2009). The results showed a more beneficial effect on waist circumference than from traditional dietary advice. In one of the studies in 29 overweight men with coronary heart disease and impaired glucose tolerance, the decrease of waist circumference was 2.7 cm greater (p=0,03) in the intervention group (-5.6 cm; 95% confidence interval [CI] -7.2;-3.9) than in the control group (-2.9, CI -4.8;-1.1) during 3 months of follow-up (Lindeberg et al., 2007). In the second study, where the same dietary model was applied in cross-over design among 13 subjects with diabetes type 2, waist circumference decreased 4 cm more (p=0,02) during the intervention diet than during the control diet (Jönsson et al., 2009). There is some evidence to suggest that cereal grains may interfere with leptin receptor activity in a way that could hypothetically suppress satiety (Jönsson et al., 2005; Kamikubo et al., 2008).
- Being tested
- Diet A, Diet B, Physiotherapy
- Keywords
- Blood pressure, Cereals, Diet Therapy, Dietary carbohydrates, Dietary fiber, Exercise Therapy, Food, Glucose intolerance, Lifestyle, Physiotherapy, Stroke, TIA, Waist circumference, Weight loss
- Medical subject headings
- Obesity, Abdominal, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension, Overweight, Glucose Intolerance, Stroke, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet ABehavioural
Also called No grains
Prudent diet without grains. Written advice and 17-20 group sessions. Subjects are advised to avoid cereal grains as much as possible. Apart from that, the recommendation is to follow Nordic Nutrition Recommendations (NNR) for overweight people (www.slv.se), i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid candy, ice cream, snacks, cakes, pastries, chocolate, potato chips, beer, soft drinks and juice. In order to match carbohydrate intake between the intervention arms, a high intake of potatoes, root vegetables, fruit and other carbohydrate-rich foods is recommended.
Guideline: 200-400 g of potatoes, 300-500 g of root crops, 400-600 g of vegetables, 200-300 g of beans, peas and corn, and 600 g of fruit and berries per day.
Diet BBehavioural
Also called Whole grains
Prudent diet with whole grains. Written advice and 17-20 group sessions. An exchange of regular cereal grains for whole grains is recommended. A daily intake of 7-8 portions of whole grain products is recommended, and a list of recommended cereal products (brands, names) is provided. Apart from that, the recommendation is identical to Diet A: to follow Nordic Nutrition Recommendations (NNR) for overweight people (www.slv.se; in Swedish), i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid candy, ice cream, snacks, cakes, pastries, chocolate, potato chips, beer, soft drinks and juice. The goal is that carbohydrate intake, as a proportion of total energy intake, should not differ between the groups.
PhysiotherapyBehavioural
Also called Exercise
Twelve physiotherapy-led, charged, 2-hour sessions of structured group training for increased cardiorespiratory fitness. A pedometer sold at the start. Physical activity on prescription (FaR) at the end.
| Study group | Role | What they receive |
|---|---|---|
| Diet A and physiotherapy | Active comparator | Behavioral: Diet A Prudent diet without grains. Written advice and 17-20 group sessions. Subjects are advised to avoid cereal grains. Apart from that, the recommendation is to follow Nordic Nutrition Recommendations (NNR) for overweight people, i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid junk food and juice. In order to match carbohydrate intake between the arms, a high intake of potatoes, root vegetables, fruit and other carbohydrate-rich foods is recommended.
Behavioral: Physiotherapy Twelve physiotherapy-led, charged, 2-hour sessions of structured group training for increased cardiorespiratory fitness. A pedometer sold at the start. Physical activity on prescription (FaR) at the end. Receives: Behavioral: Diet A; Behavioral: Physiotherapy |
| Diet B and physiotherapy | Active comparator | Behavioral: Diet B Prudent diet with whole grains. Written advice and 17-20 group sessions. An exchange of regular cereal grains for whole grains is recommended. A daily intake of 7-8 portions of whole grain products is recommended, and a list of recommended cereal products (brands, names) is provided. Apart from that, the recommendation is identical to Diet A.
Other Name: Whole grains Behavioral: Physiotherapy Twelve physiotherapy-led, charged, 2-hour sessions of structured group training for increased cardiorespiratory fitness. A pedometer sold at the start. Physical activity on prescription (FaR) at the end.
Other Name: Exercise Receives: Behavioral: Diet B; Behavioral: Physiotherapy |
| Diet A only | Active comparator | Behavioral: Diet A Prudent diet without grains. Written advice and 17-20 group sessions. Subjects are advised to avoid cereal grains as much as possible. Apart from that, the recommendation is to follow Nordic Nutrition Recommendations (NNR) for overweight people (www.slv.se; in Swedish), i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid candy, ice cream, snacks, cakes, pastries, chocolate, potato chips, beer, soft drinks and juice. In order to match carbohydrate intake between the intervention arms, a high intake of potatoes, root vegetables, fruit and other carbohydrate-rich foods is recommended.
Other Name: No grains Receives: Behavioral: Diet A |
| Diet B only | Active comparator | Behavioral: Diet B Prudent diet with whole grains. Written advice and 17-20 group sessions. An exchange of regular cereal grains for whole grains is recommended. A daily intake of 7-8 portions of whole grain products is recommended, and a list of recommended cereal products (brands, names) is provided. Apart from that, the recommendation is identical to Diet A. The goal is that carbohydrate intake, as a proportion of total energy intake, should not differ between the groups.
Other Name: Whole grains Receives: Behavioral: Diet B |
| Control | No intervention | Only follow-up. No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of waist circumference
Waist circumference (at elbow level) will be measured at baseline and after 3, 6, 12 and 24 months.
Measured: 2 years
Secondary outcomes (7)
Change of systolic and diastolic blood pressure
At baseline and after 3, 6, 12 and 24 months, sitting blood pressure will be measured twice at heart level with an automated device.
Measured: 2 years
Change of body fat percentage
At baseline and after 12 and 24 months, total body fat percentage will be assessed by use of a Tanita hand-foot-BIA. Thickness of subcutaneous fat will be assessed by use of a Harpenden skinfold caliper at four sites (biceps, triceps, suprailiac and subscapular).
Measured: 2 years
Change of plasma non-HDL cholesterol
Non-fasting plasma total and HDL cholesterol will be measured at baseline and after 3, 6, 12 and 24 months. HDL cholesterol will be subtracted from total cholesterol.
Measured: 2 years
Change of physical activity level
A hip-mounted ActiGraph accelerometer will be worn daytime for six days at baseline and after 12 and 24 months for continuous monitoring of physical activity.
Measured: 2 years
Change of glycated hemoglobin
Only in subjects with diabetes
Measured: 2 years
Change of fasting blood sugar
Only in subjects with diabetes
Measured: 2 years
Change of quantity and dosage of blood sugar-lowering drugs
All subjects will be analyzed.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by Lund 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Principal investigator, TJonsson, Lund University
- Investigators
- Staffan Lindeberg, MD PhD, Study chair, Center for Primary Health Care research, CRC, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208558
- Sponsor's protocol ID
- LU2010/332
- Acronym
- GET
- Status last verified
- Jun 2017
- First submitted
- 23 Sep 2010
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.
PubMed 17583796Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.
PubMed 19604407Kamikubo Y, Dellas C, Loskutoff DJ, Quigley JP, Ruggeri ZM. Contribution of leptin receptor N-linked glycans to leptin binding. Biochem J. 2008 Mar 15;410(3):595-604. doi: 10.1042/BJ20071137.
PubMed 17983356Jonsson T, Olsson S, Ahren B, Bog-Hansen TC, Dole A, Lindeberg S. Agrarian diet and diseases of affluence--do evolutionary novel dietary lectins cause leptin resistance? BMC Endocr Disord. 2005 Dec 10;5:10. doi: 10.1186/1472-6823-5-10.
PubMed 16336696Rydhog B, Carrera-Bastos P, Granfeldt Y, Sundquist K, Jonsson T. Paleolithic diet fraction and score in post hoc data analysis of a randomized controlled trial with lifestyle interventions for abdominal obesity. BMC Nutr. 2025 Oct 2;11(1):180. doi: 10.1186/s40795-025-01165-4.
PubMed 41039470Carrera-Bastos P, Rydhog B, Fontes-Villalba M, Arvidsson D, Granfeldt Y, Sundquist K, Jonsson T. Randomised controlled trial of lifestyle interventions for abdominal obesity in primary health care. Prim Health Care Res Dev. 2024 Apr 19;25:e19. doi: 10.1017/S1463423624000069.
PubMed 38639002
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss
- ClinicalTrials.gov ID
- NCT01208558
- Acronym / sponsor ID
- GET / LU2010/332
- Keywords
- Blood pressure, Cereals, Diet Therapy, Dietary carbohydrates, Dietary fiber, Exercise Therapy, Food, Glucose intolerance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- Aug 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Sep 2010 (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 main purpose of this 2-year lifestyle experiment for waist loss is twofold:
- to compare whole grains and no grains as part of a healthy diet,
- to determine if an 8-week exercise program, led by physiotherapists, is more efficient than brief counseling and follow-up.
People with abdominal overweight (≥84 cm in women and ≥98 cm in men) and at least one additional cardiovascular risk factor, (typically hypertension, diabetes type 2 or prior cardiovascular disease) are randomly assigned to receive Diet A or Diet B, with or without a structured exercise program at the department of physiotherapy, or to a control group receiving usual care. Diet A and B both include fruit, vegetables, fish, meat, and low-fat dairy products, and differ only in that Diet A recommends exchange of cereal grains for more potatoes, root vegetables, fruit and other carbohydrate-rich foods, while Diet B recommends exchange of regular cereal grains for whole grains. The primary outcome (most important follow-up variable) is change in waist circumference during 2 years. Secondary outcome measures include blood pressure, blood lipids, level of physical activity and, in subjects with diabetes, glycated hemoglobin and fasting blood sugar.
Detailed description
This is a randomized controlled trial with 5 parallel groups of approximately equal size. Two hundred subjects with increased waist circumference (≥84 cm in women and ≥98 cm in men) and at least one additional cardiovascular risk factor will be included.
Four of the 5 groups will receive dietary advice (A or B) and 2 of them will be allocated to physiotherapy. A fifth control group will only receive usual care in addition to follow-up. Randomization will be performed by use of an internet-based random number generator from the School of Computer Science and Statistics, Trinity College, Dublin (www.random.org). randomly assigned to receive Diet A or Diet B, with or without a structured exercise program at the department of physiotherapy, or to a control group receiving usual care.
In addition to primary (waist loss) and secondary outcome measures as given below, a health questionnaire will be performed at baseline and after 12 and 24 months with questions about general health, self-reported quality of life, medication use, living habits, physical activity, nutrition, tobacco, alcohol, personal motivation and perceived ability to change lifestyle. Furthermore, serum creatinine will be measured at baseline, and after 3, 6, 12 and 24 months.
There are few randomized controlled trials comparing the effect of different lifestyle interventions on physical activity level or weight loss in overweight people at high risk of cardiovascular disease. There is no such study of the possible effect of a structured exercise program with group training led by physiotherapists, with the exception of rehabilitation programs after myocardial infarction. In addition, the possible unique effect of cereal grains on satiety and energy intake has not been addressed in randomized controlled trials. In two earlier studies in glucose intolerance and diabetes type 2, we have applied a dietary model (Paleolithic diet) based on root vegetables, fruit, vegetables, meat and fish, partly at the expense of cereal grains (Lindeberg et al., 2007; Jönsson et al., 2009). The results showed a more beneficial effect on waist circumference than from traditional dietary advice. In one of the studies in 29 overweight men with coronary heart disease and impaired glucose tolerance, the decrease of waist circumference was 2.7 cm greater (p=0,03) in the intervention group (-5.6 cm; 95% confidence interval [CI] -7.2;-3.9) than in the control group (-2.9, CI -4.8;-1.1) during 3 months of follow-up (Lindeberg et al., 2007). In the second study, where the same dietary model was applied in cross-over design among 13 subjects with diabetes type 2, waist circumference decreased 4 cm more (p=0,02) during the intervention diet than during the control diet (Jönsson et al., 2009). There is some evidence to suggest that cereal grains may interfere with leptin receptor activity in a way that could hypothetically suppress satiety (Jönsson et al., 2005; Kamikubo et al., 2008).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Diet A and physiotherapy | Active comparator | Behavioral: Diet A, Behavioral: PhysiotherapyBehavioral: Diet A Prudent diet without grains. Written advice and 17-20 group sessions. Subjects are advised to avoid cereal grains. Apart from that, the recommendation is to follow Nordic Nutrition Recommendations (NNR) for overweight people, i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid junk food and juice. In order to match carbohydrate intake between the arms, a high intake of potatoes, root vegetables, fruit and other carbohydrate-rich foods is recommended. Behavioral: Physiotherapy Twelve physiotherapy-led, charged, 2-hour sessions of structured group training for increased cardiorespiratory fitness. A pedometer sold at the start. Physical activity on prescription (FaR) at the end. |
| Diet B and physiotherapy | Active comparator | Behavioral: Diet B, Behavioral: PhysiotherapyBehavioral: Diet B Prudent diet with whole grains. Written advice and 17-20 group sessions. An exchange of regular cereal grains for whole grains is recommended. A daily intake of 7-8 portions of whole grain products is recommended, and a list of recommended cereal products (brands, names) is provided. Apart from that, the recommendation is identical to Diet A. Other Name: Whole grains Behavioral: Physiotherapy Twelve physiotherapy-led, charged, 2-hour sessions of structured group training for increased cardiorespiratory fitness. A pedometer sold at the start. Physical activity on prescription (FaR) at the end. Other Name: Exercise |
| Diet A only | Active comparator | Behavioral: Diet ABehavioral: Diet A Prudent diet without grains. Written advice and 17-20 group sessions. Subjects are advised to avoid cereal grains as much as possible. Apart from that, the recommendation is to follow Nordic Nutrition Recommendations (NNR) for overweight people (www.slv.se; in Swedish), i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid candy, ice cream, snacks, cakes, pastries, chocolate, potato chips, beer, soft drinks and juice. In order to match carbohydrate intake between the intervention arms, a high intake of potatoes, root vegetables, fruit and other carbohydrate-rich foods is recommended. Other Name: No grains |
| Diet B only | Active comparator | Behavioral: Diet BBehavioral: Diet B Prudent diet with whole grains. Written advice and 17-20 group sessions. An exchange of regular cereal grains for whole grains is recommended. A daily intake of 7-8 portions of whole grain products is recommended, and a list of recommended cereal products (brands, names) is provided. Apart from that, the recommendation is identical to Diet A. The goal is that carbohydrate intake, as a proportion of total energy intake, should not differ between the groups. Other Name: Whole grains |
| Control | No intervention | –Only follow-up. No intervention. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- increased waist circumference (≥84 cm in women and ≥98 cm in men)
- AND at least one additional cardiovascular risk factor: hypertension, diabetes type 2, prior coronary heart disease, prior stroke/TIA, peripheral arterial disease, impaired glucose tolerance, prior gestational diabetes, heredity or smoking
Key exclusion criteria (7 listed)
- dependence on walking aids
- difficulty to understand Swedish (written or spoken)
- BMI >40 kg/m2
- cognitive impairment
- pronounced hearing loss
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 AAlso: No grainsPrudent diet without grains. Written advice and 17-20 group sessions. Subjects are advised to avoid cereal grains as much as possible. Apart from that, the recommendation is to follow Nordic Nutrition Recommendations (NNR) for overweight people (www.slv.se), i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid candy, ice cream, snacks, cakes, pastries, chocolate, potato chips, beer, soft drinks and juice. In order to match carbohydrate intake between the intervention arms, a high intake of potatoes, root vegetables, fruit and other carbohydrate-rich foods is recommended. Guideline: 200-400 g of potatoes, 300-500 g of root crops, 400-600 g of vegetables, 200-300 g of beans, peas and corn, and 600 g of fruit and berries per day. | Behavioural | Diet A and physiotherapy, Diet A only |
| Diet BAlso: Whole grainsPrudent diet with whole grains. Written advice and 17-20 group sessions. An exchange of regular cereal grains for whole grains is recommended. A daily intake of 7-8 portions of whole grain products is recommended, and a list of recommended cereal products (brands, names) is provided. Apart from that, the recommendation is identical to Diet A: to follow Nordic Nutrition Recommendations (NNR) for overweight people (www.slv.se; in Swedish), i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid candy, ice cream, snacks, cakes, pastries, chocolate, potato chips, beer, soft drinks and juice. The goal is that carbohydrate intake, as a proportion of total energy intake, should not differ between the groups. | Behavioural | Diet B and physiotherapy, Diet B only |
| PhysiotherapyAlso: ExerciseTwelve physiotherapy-led, charged, 2-hour sessions of structured group training for increased cardiorespiratory fitness. A pedometer sold at the start. Physical activity on prescription (FaR) at the end. | Behavioural | Diet A and physiotherapy, Diet B and physiotherapy |
Primary outcome
Change of waist circumference
Time frame: 2 years
Waist circumference (at elbow level) will be measured at baseline and after 3, 6, 12 and 24 months.
7 secondary outcomes
Change of systolic and diastolic blood pressure
Time frame: 2 years
Change of body fat percentage
Time frame: 2 years
Change of plasma non-HDL cholesterol
Time frame: 2 years
Change of physical activity level
Time frame: 2 years
Change of glycated hemoglobin
Time frame: 2 years
Change of fasting blood sugar
Time frame: 2 years
Change of quantity and dosage of blood sugar-lowering drugs
Time frame: 2 years
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 20 Jun 2017.
- Background: PubMed 17583796Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.
- Background: PubMed 19604407Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.
- Background: PubMed 17983356Kamikubo Y, Dellas C, Loskutoff DJ, Quigley JP, Ruggeri ZM. Contribution of leptin receptor N-linked glycans to leptin binding. Biochem J. 2008 Mar 15;410(3):595-604. doi: 10.1042/BJ20071137.
- Background: PubMed 16336696Jonsson T, Olsson S, Ahren B, Bog-Hansen TC, Dole A, Lindeberg S. Agrarian diet and diseases of affluence--do evolutionary novel dietary lectins cause leptin resistance? BMC Endocr Disord. 2005 Dec 10;5:10. doi: 10.1186/1472-6823-5-10.
- Derived from this study: PubMed 41039470Rydhog B, Carrera-Bastos P, Granfeldt Y, Sundquist K, Jonsson T. Paleolithic diet fraction and score in post hoc data analysis of a randomized controlled trial with lifestyle interventions for abdominal obesity. BMC Nutr. 2025 Oct 2;11(1):180. doi: 10.1186/s40795-025-01165-4.
- Derived from this study: PubMed 38639002Carrera-Bastos P, Rydhog B, Fontes-Villalba M, Arvidsson D, Granfeldt Y, Sundquist K, Jonsson T. Randomised controlled trial of lifestyle interventions for abdominal obesity in primary health care. Prim Health Care Res Dev. 2024 Apr 19;25:e19. doi: 10.1017/S1463423624000069.
- Individual participant dataSharing planned: Undecided
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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.
Staffan Lindeberg, MD PhD study chair
Center for Primary Health Care research, CRC, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Diet A, Diet B and Physiotherapy in people with Abdominal Obesity and Cardiovascular Diseases, run by Lund 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 2 inclusion and 7 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 20 Jun 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of waist circumference (time frame: 2 years). 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 NCT01208558, which also lists 6 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 20 Jun 2017.