The Effect of Weight Loss and Dietary Protein Intake on Bone

NCT00473031 | Completed DMC

• 3 other identifiers: AG0079R01AG012161FP00011588
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weight Loss; Bone Density

Keywords

bone mass; calcium absorption; bone quality; fracture risk

Outcome Measures

Primary Outcomes (1)

• Changes in Bone density and quality

  one year

Secondary Outcomes (2)

• Changes in serum and urine bone markers, hormones, and proteins

  one year

• Nutrient Adequacy & Diet Quality with normal & higher protein intake

  one year

Other Outcomes (1)

• Glomerular Filtration Rate with two levels of protein intake

  one year

Study Arms (2)

1

EXPERIMENTAL

High Protein

Behavioral: Caloric restriction, high protein; Behavioral: Counseling

2

ACTIVE COMPARATOR

Normal Protein

Behavioral: Caloric restriction; normal protein; Behavioral: Counseling

Interventions

Caloric restriction, high protein BEHAVIORAL

Weight loss with higher protein (35%) intake

1

Caloric restriction; normal protein BEHAVIORAL

Weight loss with recommended level of protein (18%)intake

2

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.

1; 2

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women who are more than 2 years since last menses
• Obese or overweight
• Must live in the geographic vicinity of Rutgers University

You may not qualify if:

• Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease \[i.e., heart attack or stroke in the past 6 months., abnormal EKG\], active malignancy or cancer therapy within the past year)
• History of kidney stones
• Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
• Participation in other investigational studies during the 12-month study period
• Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)

Sponsors & Collaborators

• Rutgers University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (9)

• 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.

  PMID: 16702302 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.

  PMID: 15746990 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.

  PMID: 15213038 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.

  PMID: 14742841 BACKGROUND

• 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.

  PMID: 35538903 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.

  PMID: 34338883 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.

  PMID: 21611972 RESULT

• 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.

  PMID: 24598154 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.

  PMID: 23364004 DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Caloric Restriction; Counseling

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sue A. Shapses, PhD

  Rutgers University, Nutritional Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 14, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)