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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG012161 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to determine the effect of weight loss on bone health in men.
This pilot study of the effect of weight loss on bone health in men is being undertaken in conjunction with studies of the effect of weight loss on bone health in women for comparison purposes. See NCT00473031, NCT00472680, and NCT00472654. This information is important for determining optimal nutrient requirements during weight loss.
Participants will be recruited for both weight loss and weight maintenance. All participants will be asked to take a daily vitamin/mineral supplement and, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Weight loss participants will attend regular counseling sessions (about 45 minutes each) with a dietitian for approximately 6 months; they will be asked to attend 6 sessions but will be given the opportunity to attend 13 sessions. Body composition will be measured by a dual-energy x-ray absorptiometry (DXA) machine, ultrasound, and peripheral quantitative computer tomography (pQCT) before and after 6 months of weight loss. Bone, mineral, protein and lipid markers, and hormones that influence bones will also be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WL | Experimental | weight loss (WL) with nutrition/behavior modification counseling |
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| WM | Active Comparator | Weight Maintenance (WM) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss | Behavioral | Weight loss participants will consume a reduced calorie diet based on their individual caloric needs to lose 1.5-2 lbs/week, and will attend regular counseling sessions (for about 45 minutes each) with a dietitian for 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bone density and quality | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue Shapses, PhD, RD | 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 |
| D001168 | Arthritis |
| D010024 | Osteoporosis |
| 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 |
|---|---|
| D000068959 | Body Weight Maintenance |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D049628 | Body Size |
| D006128 | Growth |
| D048788 | Growth and Development |
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| Weight Maintenance | Behavioral | Diet for weight maintenance for 6 months |
|
| 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. |
| 25733651 | Result | Pop LC, Sukumar D, Tomaino K, Schlussel Y, Schneider SH, Gordon CL, Wang X, Shapses SA. Moderate weight loss in obese and overweight men preserves bone quality. Am J Clin Nutr. 2015 Mar;101(3):659-67. doi: 10.3945/ajcn.114.088534. Epub 2015 Jan 7. |
| 35538903 | Derived | 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. |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010829 |
| Physiological Phenomena |