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| Name | Class |
|---|---|
| The Danish Council for Strategic Research | OTHER |
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The aim of this study is to investigate potential metabolic effects of whey protein high in protein and high in leucine(HPHL) compared to soy protein high in protein and low in leucine(HPLL) in osteopenic patients in a randomized controlled intervention study.
The investigator hypothesize that HPHL will increase physical function and the ratio muscle mass / fat mass in this condition.
With an increase in the older population in Denmark and most other countries there is an increase in the rate of patients with age related bone and muscle weakness. Proteins with a high content in ketogenic amino acids e.g. leucine have been investigated in relation to these conditions. Generally acute studies in animals and some in human have been conducted and have demonstrated positive effects in relation to prevention and treatment of bone and muscle weakness. We want to investigate these tendencies with supplementation of proteins in a randomized, blinded, 4 month intervention study with three arms - 1) the control group. 2) soy protein(high protein, low leucine). 3) Whey protein(high protein, high leucine). To increase any possible effect of the supplementation the subjects will complete a resistance training program concurrently. The study will focus on the anabolic properties of the ketogenic amino acids in animal whey protein compared to vegetable soy protein.
The investigator will study changes in:
The perspective in this study is to develop a nutritional supplement with a high content of ketogenic amino acids (e.g. Leucine) that can be useful and beneficial in treatment and prevention of patients with bone and muscle weakness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein (HPHL) | Experimental | Whey protein supplementation and resistance training for four month. |
|
| Soy protein (HPLL) | Experimental | Soy protein supplementation and resistance training for four month. |
|
| Placebo (P) | Placebo Comparator | Maltodextrin supplementation and resistance training for four month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein (HPHL) | Dietary Supplement | The Whey protein group are supplemented 45 gram of whey protein, high protein high leucine (HPHL), every day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 4 meter gait speed | We will measure changes in 4 meter gait speed. | Baseline and 4 months |
| Walk distance | We will measure changes in walk distance with the Six-Minute Walk Test. | Baseline and 4 months |
| Lean body mass(LBM)/Fat mass (FM) ratio. | We will measure changes in the ratio LBM/FM with a DEXA-scanner. | Baseline and 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bjørn Richelsen, Professor | The department of endocrinology, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of endocrinology, Aarhus University hospital | Aarhus C | 8000 | Denmark |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D055948 | Sarcopenia |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D030262 | Soybean Proteins |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| Soy protein (HPLL) | Dietary Supplement | The Soy protein group are supplemented 45 gram of Soy protein, high protein low leucine (HPLL), every day. |
|
| Placebo (P) | Dietary Supplement | Will not be given protein but the same energy content using maltodextrin (in a blended fashion). |
|
| Resistance training | Other | For 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes. |
|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| 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 |
| D010940 | Plant Proteins |
| D014674 | Plant Proteins, Dietary |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |