Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?

NCT ID: NCT00883038

Last Updated: 2009-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-03-31

Brief Summary

The aim of the study is to evaluate the effect of experimental (vegetarian) diet compared to conventional diet with similar caloric restriction on insulin resistance, body weight and body composition in type 2 diabetic patients after 3 month diet program and additional 3 month diet program combined with intensive exercise.

Hypothesis: Greater improvement in insulin resistance, greater weight loss without compromising the body composition (subjects will lose fat preferentially to lean body mass) and differences in the fatty tissue metabolism will be found in the experimental (vegetarian) group compared to the control (conventional diet) group despite the similar advise on caloric restriction in both diets. The differences between the two groups will increase after an intensive physical exercise program.

Detailed Description

Open randomized study. Individuals with type 2 diabetes (n=60) will be recruited through newspaper advertisements and through advertisements in the hospital. They will be randomly assigned to a low-fat vegetarian diet or a diet following the guidelines of the Study Group on Diabetes and Nutrition of the European Association for the Study of Diabetes (DNSG) (21) with similar caloric restriction (-500 kcal/d). The participants will be followed for 12 weeks and then for another 12 weeks with the addition of intensive physical exercise. All meals during the 6 months will be provided.

Conditions

Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Active Comparator

Diabetic diet following the DNSG guidelines

Group Type: ACTIVE_COMPARATOR

diabetic diet following the DNSG guidelines

Intervention Type: OTHER

The DNSG diet consists of 15-20% protein, ≤7% saturated fat, 60-70% carbohydrate and monounsaturated fats, cholesterol ≤200 mg/day, fiber content 20-30g/day.

Experimental

Low-fat vegetarian diet

Group Type: EXPERIMENTAL

low-fat vegetarian diet

Intervention Type: OTHER

The low-fat vegetarian diet (\~10% of energy from fat, 15% protein, and 75% carbohydrate, fiber content 40-50 g/day) consists of vegetables, fruits, grains, legumes and small amounts of nuts. Participants will be asked to avoid animal products and added fats and to favor low-glycemic index foods, such as beans and green vegetables.

Interventions

diabetic diet following the DNSG guidelines

The DNSG diet consists of 15-20% protein, ≤7% saturated fat, 60-70% carbohydrate and monounsaturated fats, cholesterol ≤200 mg/day, fiber content 20-30g/day.

Intervention Type: OTHER

low-fat vegetarian diet

The low-fat vegetarian diet (\~10% of energy from fat, 15% protein, and 75% carbohydrate, fiber content 40-50 g/day) consists of vegetables, fruits, grains, legumes and small amounts of nuts. Participants will be asked to avoid animal products and added fats and to favor low-glycemic index foods, such as beans and green vegetables.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Individuals with type 2 diabetes as defined by the criteria of the American Diabetes Association and recognized by WHO, Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (19,20)

2. Concurrent T2 DM therapy: The use of oral hypoglycemic medication stable for the last 3 months

3. HbA1c ≥ 4 and ≤ 9.0 % (IFCC) ~ ≥ 6.0 and ≤ 11 % (DCCT)

4. Men and women who are 30 to 70 years of age

5. Body Mass Index (kg/m2) between 25 and 53

6. Informed Consent: a signed and dated written consent obtained from the subject before any procedures are performed

7. Willing to change dietary habits and to follow the prescribed diet and exercise program

Exclusion Criteria

1. Current alcohol or drug abuse

2. Pregnancy, lactating

3. Unstable medical status

4. Diagnosis of Type 1 diabetes mellitus

5. Significant weight gain or loss (defined as ≥ 10% of total body weight) within the past 3 months prior to screening.

6. Pacemaker or metal in the body.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Institute for Clinical and Experimental Medicine

Principal Investigators

Terezie Pelikanova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Head of the Diabetes Center

Locations

Institute for Clinical and Experimental Medicine

Prague, , Czechia

Countries

Czechia

References

Kahleova H, Tonstad S, Rosmus J, Fisar P, Mari A, Hill M, Pelikanova T. The effect of a vegetarian versus conventional hypocaloric diet on serum concentrations of persistent organic pollutants in patients with type 2 diabetes. Nutr Metab Cardiovasc Dis. 2016 May;26(5):430-8. doi: 10.1016/j.numecd.2016.01.008. Epub 2016 Jan 28.

Reference Type: DERIVED

PMID: 27107842 (View on PubMed)

Kahleova H, Matoulek M, Malinska H, Oliyarnik O, Kazdova L, Neskudla T, Skoch A, Hajek M, Hill M, Kahle M, Pelikanova T. Vegetarian diet improves insulin resistance and oxidative stress markers more than conventional diet in subjects with Type 2 diabetes. Diabet Med. 2011 May;28(5):549-59. doi: 10.1111/j.1464-5491.2010.03209.x.

Reference Type: DERIVED

PMID: 21480966 (View on PubMed)

Other Identifiers

785206

Identifier Type: -

Identifier Source: org_study_id