Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- change in glucose metabolism
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals at a high risk for Type 2 diabetes:
- •positive family history of type 2 diabetes,
- •presence of metabolic syndrome,
- •body mass index (BMI) > 27 kg/m2,
- •diagnosis of impaired glucose tolerance (IGT)
- •previous diagnosis of gestational diabetes diabetes
Exclusion Criteria
- •Main exclusion criteria
- •diagnosis of type 1 or 2 diabetes mellitus
- •BMI >45 kg/m²
- •presence of serious illness such as cardiovascular, malignant or psychiatric disease.
Arms & Interventions
Caloric restriction (control)
daily reduction of caloric intake aimed at 400 kcal/day
Intervention: Caloric restriction (Behavioral)
No red meat
daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake
Intervention: no red meat (Behavioral)
Increased fiber intake
daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day)
Intervention: Increased fiber intake (Behavioral)
Outcomes
Primary Outcomes
change in glucose metabolism
Time Frame: baseline and six months
glucose metabolism measured during the oral glucose tolerance test (OGTT)
Secondary Outcomes
- Insulin secretion(baseline and six months)
- liver fat(baseline and six months)
- body composition(baseline and six months)
- liver iron content(baseline and six months)
Investigators
andreas fritsche
Professor
University Hospital Tuebingen
