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| Name | Class |
|---|---|
| Arla Foods | INDUSTRY |
| Nupo A/S, Denmark | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein supplement | Active Comparator | Whey protein |
|
| Whey protein enriched with calcium supplement | Active Comparator | Whey protein enriched with calcium |
|
| Soy protein supplement | Active Comparator | Soy protein |
|
| Control supplement | Placebo Comparator | Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | 45g protein/d; Dosage 3x15g protein daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in body weight and composition during the weight maintenance period | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in fasting blood lipid profile during the weight maintenance period. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
smoking
use of cholesterol-lowering medications or other medications considered to be of importance for participation in the trial
use of special diets (eg. Atkins, vegetarian) within 2 months before the start of the project.
elite athletes or if subjecct is planning to become elite athlete (e.g. Planning major changes in physical activity during the experiment).
When starting on a weight maintenance period:
• persons during weight loss period, loss of <8% of their initial body weight
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| Name | Affiliation | Role |
|---|---|---|
| Arne Astrup, Prof., MD | Department of Human Nutrition, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Human Nutrition, University of Copenhagen | Frederiksberg, Copenhagen | 1958 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29643928 | Derived | Geiker NRW, Veller M, Kjoelbaek L, Jakobsen J, Ritz C, Raben A, Astrup A, Lorenzen JK, Larsen LH, Bugel S. Effect of low energy diet for eight weeks to adults with overweight or obesity on folate, retinol, vitamin B12, D and E status and the degree of inflammation: a post hoc analysis of a randomized intervention trial. Nutr Metab (Lond). 2018 Apr 10;15:24. doi: 10.1186/s12986-018-0263-1. eCollection 2018. | |
| 28679554 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D002118 | Calcium |
| D030262 | Soybean Proteins |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| Whey protein enriched with calcium |
| Dietary Supplement |
45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily |
|
| Soy protein | Dietary Supplement | 45g soy protein/d; dosage 15g soy protein x 3 daily |
|
| Maltodextrin | Dietary Supplement | 48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily |
|
| 24 weeks |
| Difference in resting blood pressure and pulse during the weight maintenance period. | 24 weeks |
| Difference in intestinal flora during the weight maintenance period. | 24 weeks |
| Nutrigenomics (NMR) analysis. | 24 weeks |
| Difference in energy intake (EI) and macronutrient intake from the diet during the weight maintenance period. | 24 weeks |
| Difference in acute- and long-term effet on diet induced thermogenesis and substrate oxidation. | 24 weeks. |
| Difference in acute- and long-term effect on postprandial appetite regulation (measured via VAS, appetite regulating hormones and energy intake) | 24 weeks |
| Difference in acute- and long-term effect on postprandial response in insulin, glucose, C-peptide, and glucagon. | 24 weeks |
| Difference in appetite regulating hormones (ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)) during weight maintenance period. | 24 weeks |
| Change in body weight and composition during the weight loss period | 8 weeks |
| Change in blood lipid profile during the weight loss period | 8 weeks |
| Change in fasting insulin, glucose ect. during the weight loss period | 8 weeks |
| Change in intestinal flora during the weight loss period. | 8 weeks |
| Derived |
| Kjolbaek L, Sorensen LB, Sondertoft NB, Rasmussen CK, Lorenzen JK, Serena A, Astrup A, Larsen LH. Protein supplements after weight loss do not improve weight maintenance compared with recommended dietary protein intake despite beneficial effects on appetite sensation and energy expenditure: a randomized, controlled, double-blinded trial. Am J Clin Nutr. 2017 Aug;106(2):684-697. doi: 10.3945/ajcn.115.129528. Epub 2017 Jul 5. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D010940 | Plant Proteins |
| D014674 | Plant Proteins, Dietary |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |