Decreased Cardovascular Risk, Decreased Risk of Diabetes Mellitus Type II
Conditions
Keywords
triacylglcerides, glucose, HbA1c, body weight
Brief summary
The proposed intervention study addresses the development and validation of nutritional concepts based on menu plans for patients with hypertriglyceridemia (triglycerides \> 1.5 mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose \> 5.6 ≤ 7 mmol/l).
Detailed description
The proposed intervention study addresses the development and validation of nutritional concepts for patients with hypertriglyceridemia (triglycerides \> 1.5 mmol/l) and participants with impaired glucose tolerance (glucose \> 5.6 ≤ 7 mmol/l). The randomized, controlled study will be conducted in a parallel design with four arms. In total, 120 participants (males, females; age: 30 - 80 years) will be randomized to one of the four groups: hypertriglyceridemia concept (group A), hypertriglyceridemia control (group B), prediabetes concept (group C), and prediabetes control (group D). The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (e.g., fish or plant oil, nuts) over the study period of ten weeks. Participants in the control groups B and D are not provided with defined menu plans or study products. Blood samples will be taken at the beginning, regularly every two weeks of the ten-weeks intervention period as well as after the ten-weeks follow-up. Primary endpoints are triglycerides (group A, B), and fasting glucose (group C, D). The study design enables the comparison of the effectiveness of the developed nutritional concepts, which were adapted to the requirements of the target groups.
Interventions
DIETARY_SUPPLEMENTMenu plans
The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (plant oils, nuts mixture etc.) over the study period of 10 weeks.
Sponsors
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Intervention model description
parallel design
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Voluntary participation with documented consent * Willingness and ability to adhere to study protocol * Volunteer test person (m/f) aged ≥ 30 years and ≤ 80 years * BMI: ≥ 20 ≤ 40 kg/m2 * No or moderate alcohol consumption (≤ 2 glasses/week) * non-smoker (if possible) * Group A, B: triglycerides: \> 1.5 mmol/l * Group C, D: Fasting glucose: ≥ 5.6 ≤ 7 mmol/L
Exclusion criteria
Concomitant diseases: * Hypercholesterolemia (genetic defect / familial predisposition) * Diabetes mellitus * Thyroid dysfunction (hyper- or hypothyroidism) * Food intolerances/allergies to ingredients in the study foods * Medications: lipid-lowering drugs, glucocorticoids, oral medication for the treatment of type 1-4 diabetes mellitus, insulin injections * Dietary supplements: especially n-3 fatty acids, vitamin E * Extremely high physical activity (daily) * Alcohol abuse (daily) * (smokers) \[if there are not enough subjects available, at least 7 smokers should be included so that a statistical analysis is possible\] * Uncontrolled organic diseases * Alcohol, medication or drug abuse * Participation in other observational clinical studies during or 4 wk. before starting this study * Severe behavioral, emotional, or psychiatric problems that the investigator determined would result in non-compliance * Pregnancy, lactation and unsafe contraception * Other reasons considered important by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triacylglcerides, mmol/l (group A, B) | Change from baseline after 10 weeks | Cardiovascular risk factor |
| Fasting glucose, mmol/l (group C, D) | Change from baseline after 10 weeks | Diabetes risk factor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin E (µmol/l) | Change from baseline after 10 weeks | Vitamins |
| Transferrin (g/l) | Change from baseline after 10 weeks | Minerals and trace elements |
| Iodine (µmol/l) | Change from baseline after 10 weeks | Minerals and trace elements |
| Selenium (µmol/l) | Change from baseline after 10 weeks | Minerals and trace elements |
| Zinc (µmol/l) | Change from baseline after 10 weeks | Minerals and trace elements |
| Total cholesterol (mmol/l) | Change from baseline after 10 weeks | Cardiovascular risk factor |
| HDL cholesterol (mmol/l) | Change from baseline after 10 weeks | Cardiovascular risk factor |
| LDL cholesterol (mmol/l) | Change from baseline after 10 weeks | Cardiovascular risk factor |
| Systolic pressure (mm Hg) | Change from baseline after 10 weeks | Cardiovascular risk factor |
| Diastolic pressure (mm Hg) | Change from baseline after 10 weeks | Cardiovascular risk factor |
| Insulin (mU/l) | Change from baseline after 10 weeks | Diabetes risk factor |
| HbA1c (%) | Change from baseline after 10 weeks | Diabetes risk factor |
| Body weight (kg) | Change from baseline after 10 weeks | Cardiovascular risk factor |
| Body fat (kg) | Change from baseline after 10 weeks | Cardiovascular risk factor |
| High sensitive c-reactive protein (mg/l) | Change from baseline after 10 weeks | Inflammatory marker |
| Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters) | Change from baseline after 10 weeks | Fatty acid distribution in erythrocyte lipids |
| Vitamin A (mmol/l) | Change from baseline after 10 weeks | Vitamins |
| Vitamin D (nmol/l) | Change from baseline after 10 weeks | Vitamins |
| Vitamin B1 (nmol/l) | Change from baseline after 10 weeks | Vitamins |
| Vitamin B6 (nmol/l) | Change from baseline after 10 weeks | Vitamins |
| Vitamin B12 (pmol/l) | Change from baseline after 10 weeks | Vitamins |
| Holo-transcobalamin (pmol/l) | Change from baseline after 10 weeks | Vitamins |
| Folic acid (µg/l) | Change from baseline after 10 weeks | Vitamins |
| Vitamin H (ng/l) | Change from baseline after 10 weeks | Vitamins |
| Vitamin C (mg/l) | Change from baseline after 10 weeks | Vitamins |
| Potassium (mmol/l) | Change from baseline after 10 weeks | Minerals and trace elements |
| Iron (µmol/l) | Change from baseline after 10 weeks | Minerals and trace elements |
| Ferritin (µg/l) | Change from baseline after 10 weeks | Minerals and trace elements |
Other
| Measure | Time frame | Description |
|---|---|---|
| Zinc (µmol/24 h) | Change from baseline after 10 weeks | Zinc (24 h urine) |
| Albumine (mg/l) | Change from baseline after 10 weeks | Albumine (24 h urine) |
| Creatinine (mmol/l) | Change from baseline after 10 weeks | Creatinine (24 h urine) |
| Selenium (µmol/24 h) | Change from baseline after 10 weeks | Selenmium (24 h urine) |
Countries
Germany
Outcome results
None listed