Clinical trial NCT01208558: Grain Exercise Trial - Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss
Official title: Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Abdominal Obesity
Cardiovascular Diseases
Diabetes Type 2
Hypertension
Overweight
Keywords: Blood pressure
Cereals
Diet Therapy
Dietary carbohydrates
Dietary fiber
Exercise Therapy
Food
Glucose intolerance
Lifestyle
Physiotherapy
Stroke
TIA
Waist circumference
Weight loss
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Region Skane
First posted: 2010-09-24
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of waist circumference
timeFrame: 2 years
Secondary outcomes:
measure: Change of systolic and diastolic blood pressure
timeFrame: 2 years
measure: Change of body fat percentage
timeFrame: 2 years
measure: Change of plasma non-HDL cholesterol
timeFrame: 2 years
measure: Change of physical activity level
timeFrame: 2 years
measure: Change of glycated hemoglobin
timeFrame: 2 years
measure: Change of fasting blood sugar
timeFrame: 2 years
measure: Change of quantity and dosage of blood sugar-lowering drugs
timeFrame: 2 years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Center for Primary Health Care Research, CRC, Lund University, Sweden
state: Skane
Study officials:
affiliation: Center for Primary Health Care research, CRC, Lund University
name: Staffan Lindeberg, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Jonsson 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.
citation: Kamikubo 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.
citation: Jonsson 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.