Effect of a proprietary potato protease inhibitor on satiety, cholecystokinin concentration, weight loss and cognitive status in overweight individuals with increased waist circumference.
- Conditions
- E66Obesity
- Registration Number
- DRKS00015821
- Lead Sponsor
- Herbalife Nutrition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 52
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
BMI > 40 kg/m². Body weight fluctuations of > 2% in the last month.
Estimated energy requirement / day < 1500 kcal
Adherence to a diet with < 800 Kcal/d longer than 4 months in the last 12 months. Weight loss of > 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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Satiety - after 0, 10 and 20 weeks <br>Measuring instrument is a questionnaire according to Flint<br>(Int J Obes Relat Metab Disord 2000;24(1):38-48)
- Secondary Outcome Measures
Name Time Method Cholecystokinin, glucagon-like peptide 1, ghrelin,<br>insulin. <br>Methods: Radioimmunoassay, Elisa Kit<br><br>Time of measurement: <br>Day 1, week 0 and day 1, 10th week, both before and after taking a test meal.<br> <br>Anthropometric measurement:<br>Percentage change in weight, waist circumference (scale and tape measure), blood pressure (blood pressure monitor measurement), triglycerides, HDL cholesterol (routine clinical chemistry methods).<br>Time week 0,10, 20 <br>