E66
Conditions
Interventions
Group 1: Individually tailored protein-rich reduction diet with 3 main meals over 20 weeks. One capsule (PI2 inhibitor, 150 mg) with 200 ml water is taken one hour before lunch and dinner. The degree
Sponsors
Herbalife Nutrition
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 25 - 55 years, women or men. Negative pregnancy test. Surgical sterilization, menopause for at least 6 months or contraception by spiral or hormones. BMI 25 - 40 kg/m² and waist circumference women > 80 cm, men > 94 cm Health, determined by anamnesis, clinical examination and laboratory tests (blood count, Na, K, Ca, urea, creatinine, uric acid, ALT, AST, AP, GT, bilirubin, basal TSH, triglycerides, total cholesterol, HDL cholesterol, blood sugar, serum insulin, HbA1c and urine status). Stable body weight in the last 3 months (fluctuation <2%). Willingness to complete visual analogue scale (VAS) four times on 5 days and at test meals. Willingness to prepare a diet protocol 4 times on 3 days. Willingness to take blood samples before and after a test meal both at the beginning of the study and after 10 weeks. To have been informed that normal care is provided even if participation in the study is not desired. Tolerance of the test meal. Written consent to participate in the study
Exclusion criteria
Exclusion criteria: BMI > 40 kg/m². Body weight fluctuations of > 2% in the last month. Estimated energy requirement / day 10 kg in the last 6 months. Surgical measures due to obesity. Diabetes mellitus, CVD, kidney or liver disease, psychiatric diseases. Abnormal laboratory parameters (serum creatinine, ALT, AST, bilirubin, TSH, triglycerides > 5.0 mol/l, cholesterol > 9.0 mmol/l). Desire to have children, breastfeeding mothers. Taking medication for weight loss or medication for diseases whose course cannot yet be estimated. Smokers, alcohol consumption > 2 drinks/day Allergies to potatoes, Panax ginseng or roseroot. Drug and medication abuse hypothyroidism that is not already treated with thyroid hormone Patients with pacemakers, metal plates, piercing that cannot be removed. Taking test substances in the last 8 weeks. Intolerance of the test meal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Satiety - after 0, 10 and 20 weeks Measuring instrument is a questionnaire according to Flint (Int J Obes Relat Metab Disord 2000;24(1):38-48) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cholecystokinin, glucagon-like peptide 1, ghrelin, insulin. Methods: Radioimmunoassay, Elisa Kit Time of measurement: Day 1, week 0 and day 1, 10th week, both before and after taking a test meal. Anthropometric measurement: Percentage change in weight, waist circumference (scale and tape measure), blood pressure (blood pressure monitor measurement), triglycerides, HDL cholesterol (routine clinical chemistry methods). Time week 0,10, 20 | — |
Countries
Germany
Contacts
Public ContactMarion Flechtner-Mors
Universitätsklinikum Ulm
Outcome results
None listed