Grain Exercise Trial - Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss

NCT01208558 | Completed Phase 2

• 1 other identifier: LU2010/332
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this 2-year lifestyle experiment for waist loss is twofold:

1. 1.to compare whole grains and no grains as part of a healthy diet,
2. 2.to determine if an 8-week exercise program, led by physiotherapists, is more efficient than brief counseling and follow-up.

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

Outcome Measures

Primary Outcomes (1)

• Change of waist circumference

  Waist circumference (at elbow level) will be measured at baseline and after 3, 6, 12 and 24 months.

  2 years

Secondary Outcomes (7)

• Change of systolic and diastolic blood pressure

  2 years

• Change of body fat percentage

  2 years

• Change of plasma non-HDL cholesterol

  2 years

• Change of physical activity level

  2 years

• Change of glycated hemoglobin

  2 years

Study Arms (5)

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.

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

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

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

Behavioral: Diet B

Control

NO INTERVENTION

Only follow-up. No intervention.

Interventions

Diet A BEHAVIORAL

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.

Also known as: No grains

Diet A and physiotherapy; Diet A only

Diet B BEHAVIORAL

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.

Also known as: Whole grains

Diet B and physiotherapy; Diet B only

Physiotherapy BEHAVIORAL

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.

Also known as: Exercise

Diet A and physiotherapy; Diet B and physiotherapy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• Region Skane: collaborator

Study Sites (1)

Center for Primary Health Care Research, CRC, Lund University, Sweden

Lund, Skåne County, Sweden

Location

Related Publications (5)

• 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.

  PMID: 17583796 BACKGROUND

• 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.

  PMID: 19604407 BACKGROUND

• 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.

  PMID: 17983356 BACKGROUND

• 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.

  PMID: 16336696 BACKGROUND

• Rydhog 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.

  PMID: 41039470 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Hypertension; Overweight; Glucose Intolerance; Stroke; Weight Loss

Interventions

Whole Grains; Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

Obesity; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Hyperglycemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Body Weight Changes

Intervention Hierarchy (Ancestors)

Edible Grain; Crops, Agricultural; Food; Diet, Food, and Nutrition; Physiological Phenomena; Seeds; Food and Beverages; Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Staffan Lindeberg, MD PhD

  Center for Primary Health Care research, CRC, Lund University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 24, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

SE (1)