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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG012161 | U.S. NIH Grant/Contract | View source | |
| FP00011588 | Other Grant/Funding Number | Institute for the Advancement of Food and Nutrition Sciences |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to learn how the amount of protein during moderate weight loss influences bone health. We will also examine how two levels of protein intake affects diet quality.
It is unclear whether protein intake during dieting influences bone density. This information is important for determining optimal nutrient requirements during weight loss. This study will compare the effects of weight loss with a lower-carbohydrate, high-protein (HP) diet to a high-carbohydrate, moderate protein (HC) diet on bone mass and quality in postmenopausal women (ages 50-70 years) with the hypothesis that bone turnover and loss of bone will be reduced on the HP compared to the HC weight loss diet. In a secondary aim, we will examine bone markers, hormones and the impact of protein intake on diet quality.
Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended level of protein intake, and B) weight loss with higher protein intake. All participants will attend regular counseling sessions (about 50 minutes per session) with a dietitian for approximately 1 year, and will be asked to take a daily vitamin/mineral supplement. Also, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Bone, mineral, protein and lipid markers, and hormones that influence bones will be measured. These measurements will provide information about body composition (fat, muscle mass, and bone mineral density). Participants will be asked to attend 8 diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions during the year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | High Protein |
|
| 2 | Active Comparator | Normal Protein |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caloric restriction, high protein | Behavioral | Weight loss with higher protein (35%) intake |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Bone density and quality | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum and urine bone markers, hormones, and proteins | one year | |
| Nutrient Adequacy & Diet Quality with normal & higher protein intake | healthy eating index score | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular Filtration Rate with two levels of protein intake | GFR | one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue A. Shapses, PhD | Rutgers University, Nutritional Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16702302 | Background | Shapses SA, Riedt CS. Bone, body weight, and weight reduction: what are the concerns? J Nutr. 2006 Jun;136(6):1453-6. doi: 10.1093/jn/136.6.1453. | |
| 15746990 | Background | Riedt CS, Cifuentes M, Stahl T, Chowdhury HA, Schlussel Y, Shapses SA. Overweight postmenopausal women lose bone with moderate weight reduction and 1 g/day calcium intake. J Bone Miner Res. 2005 Mar;20(3):455-63. doi: 10.1359/JBMR.041132. Epub 2004 Nov 29. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Caloric restriction; normal protein |
| Behavioral |
Weight loss with recommended level of protein (18%)intake |
|
| Counseling | Behavioral | Participants will be asked to attend eight 50-minute diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions, during the year. |
|
| 15213038 | Background | Cifuentes M, Riedt CS, Brolin RE, Field MP, Sherrell RM, Shapses SA. Weight loss and calcium intake influence calcium absorption in overweight postmenopausal women. Am J Clin Nutr. 2004 Jul;80(1):123-30. doi: 10.1093/ajcn/80.1.123. |
| 14742841 | Background | Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7. doi: 10.1038/oby.2004.7. |
| 35538903 | Result | Ogilvie AR, Schlussel Y, Sukumar D, Meng L, Shapses SA. Higher protein intake during caloric restriction improves diet quality and attenuates loss of lean body mass. Obesity (Silver Spring). 2022 Jul;30(7):1411-1419. doi: 10.1002/oby.23428. Epub 2022 May 11. |
| 34338883 | Result | Ogilvie AR, Watford M, Wu G, Sukumar D, Kwon J, Shapses SA. Decreased fasting serum glucogenic amino acids with a higher compared to normal protein diet during energy restriction in women: a randomized controlled trial. Amino Acids. 2021 Sep;53(9):1467-1472. doi: 10.1007/s00726-021-03053-0. Epub 2021 Aug 2. |
| 21611972 | Result | Sukumar D, Ambia-Sobhan H, Zurfluh R, Schlussel Y, Stahl TJ, Gordon CL, Shapses SA. Areal and volumetric bone mineral density and geometry at two levels of protein intake during caloric restriction: a randomized, controlled trial. J Bone Miner Res. 2011 Jun;26(6):1339-48. doi: 10.1002/jbmr.318. |
| 24598154 | Derived | Green CO, Badaloo AV, Hsu JW, Taylor-Bryan C, Reid M, Forrester T, Jahoor F. Effects of randomized supplementation of methionine or alanine on cysteine and glutathione production during the early phase of treatment of children with edematous malnutrition. Am J Clin Nutr. 2014 May;99(5):1052-8. doi: 10.3945/ajcn.113.062729. Epub 2014 Mar 5. |
| 23364004 | Derived | Shapses SA, Sukumar D, Schneider SH, Schlussel Y, Sherrell RM, Field MP, Ambia-Sobhan H. Vitamin D supplementation and calcium absorption during caloric restriction: a randomized double-blind trial. Am J Clin Nutr. 2013 Mar;97(3):637-45. doi: 10.3945/ajcn.112.044909. Epub 2013 Jan 30. |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |