Insulin Sensitivity, Liver Fat, Nutritional and Metabolic Diseases, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
BEHAVIORALCaloric 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).
BEHAVIORALno 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).
BEHAVIORALIncreased 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).
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in glucose metabolism | baseline and six months | glucose metabolism measured during the oral glucose tolerance test (OGTT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin secretion | baseline and six months | Disposition index (insulin sensitivity (Matsuda) x insulinogenic index (IGI)) |
| liver fat | baseline and six months | measured by magnetic resonance spectroscopy |
| liver iron content | baseline and six months | measured by magnetic resonance imaging |
| body composition | baseline and six months | measured by magnetic resonance imaging |
Countries
Germany
Outcome results
None listed