NCT03231839

Nutritional Prevention of Diabetes Mellitus Type 2

Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the influence of red meat and fibers on glucose metabolism and body fat composition in subjects at increased risk for type 2 diabetes.

Detailed description

The epidemiologic evidence for increased red meat intake and decreased fiber intake as risk factors for T2D is solid. However, few intervention studies have been performed in order to investigate the role of whole-grain intake or the consumption of red meat in glycemic control and prevention of diabetes, yielding contradicting results. Thus, in order to prove causality, further identify potential underlying mechanisms and be able to improve lifestyle modification programs, we performed a randomized, controlled intervention study over six months. The participants are individuals at increased risk for tyoe 2 diabetes. They were randomised to 3 interventions groups: 1) caloric restriction of 400 kcal/day (control group), 2) caloric restriction plus no red meat consumption 3) caloric restriction and increase in fiber intake. Subjects where thoroughly phenotyped by anthropometric parameters, oral glucose tolerance tests, and MRI measurements of body fat composition and iron content in the liver. In this study, we want to compare the effectiveness of reduced caloric intake only versus reduced caloric intake with an additional modification of diet composition in terms of red meat and fiber consumption.

Conditions

• Type 2 Diabetes Mellitus
• Nutritional and Metabolic Diseases
• Liver Fat
• Insulin Sensitivity

Interventions

Type	Name	Description
BEHAVIORAL	Caloric restriction	After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
BEHAVIORAL	no red meat	After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
BEHAVIORAL	Increased fiber intake	After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-06-30
• Completion: 2016-07-31
• First posted: 2017-07-27
• Last updated: 2017-07-27

Locations

1 site across 1 country: Germany