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Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes
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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
University of Tuebingen
Tübingen, Germany
Start Date
February 1, 2009
Primary Completion Date
June 30, 2012
Completion Date
July 31, 2016
Last Updated
July 27, 2017
132
ACTUAL participants
Caloric restriction
BEHAVIORAL
no red meat
BEHAVIORAL
Increased fiber intake
BEHAVIORAL
Lead Sponsor
University Hospital Tuebingen
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04943861