The primary aim is to examine the effect of a high protein intake (from soy or whey protein) on weightmaintenance after weight loss in a group of predisposed (severe) obese persons. Furthermore, to examine short-term and long-term effect of a high protein intake on appetite regulation and diet induced thermogenese (DIT). Finally to examine the effect of calcium on weightmaintence, bloodlipid profilen, appetite regulation and DIT. The study is a parallel RCT with a weight loss (WL) period (8 weeks on very low calorie diet) and a weightmaintence (WM) period (24 weeks daily intake of supplement). 200 overweight/obese subjects will be enrolled into the study and randomized to placebo (maltodextrin), soy protein, whey protein or calcium enriched whey protein supplement. At baseline (week 0), after the WL period (week 8) and after WM period (week 24) body weight and composition will be measured and blood samples will be collected. Meal test will be performed at week 0 and 24 (examining both appetite regulation and DIT). Urine and feces will be collected three times during the study. Subjects will receive dietary counseling (in groups) regularly during the study and body weight will be measured at each visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
223
45g protein/d; Dosage 3x15g protein daily
45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily
45g soy protein/d; dosage 15g soy protein x 3 daily
48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily
Department of Human Nutrition, University of Copenhagen
Frederiksberg, Copenhagen, Denmark
Difference in body weight and composition during the weight maintenance period
Time frame: 24 weeks
Difference in fasting blood lipid profile during the weight maintenance period.
Time frame: 24 weeks
Difference in fasting insulin, glucose, C-peptide, glucagon, insulin-like growth factor 1 (IGF-1), ionized calcium, parathyroideahormone (PTH), and angiopoietin-like protein 4 (Angpt14) during the weight maintenance period.
Time frame: 24 weeks
Difference in resting blood pressure and pulse during the weight maintenance period.
Time frame: 24 weeks
Difference in intestinal flora during the weight maintenance period.
Time frame: 24 weeks
Nutrigenomics (NMR) analysis.
Time frame: 24 weeks
Difference in energy intake (EI) and macronutrient intake from the diet during the weight maintenance period.
Time frame: 24 weeks
Difference in acute- and long-term effet on diet induced thermogenesis and substrate oxidation.
Time frame: 24 weeks.
Difference in acute- and long-term effect on postprandial appetite regulation (measured via VAS, appetite regulating hormones and energy intake)
Time frame: 24 weeks
Difference in acute- and long-term effect on postprandial response in insulin, glucose, C-peptide, and glucagon.
Time frame: 24 weeks
Difference in appetite regulating hormones (ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)) during weight maintenance period.
Time frame: 24 weeks
Change in body weight and composition during the weight loss period
Time frame: 8 weeks
Change in blood lipid profile during the weight loss period
Time frame: 8 weeks
Change in fasting insulin, glucose ect. during the weight loss period
Time frame: 8 weeks
Change in intestinal flora during the weight loss period.
Time frame: 8 weeks
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