The Effect of Severe Weight Loss and Protein Intake on Bone

NCT00472680 | Terminated DMC

• 2 other identifiers: AG00825R01AG012161
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn whether the amount of dietary protein can influence bone health during the weight loss after weight loss surgery.

Conditions

Weight Loss

Keywords

bone mass; calcium absorption; bone quality; fracture risk

Outcome Measures

Primary Outcomes (1)

• Changes in Bone mineral density and quality

  one year

Secondary Outcomes (1)

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

  one year

Study Arms (2)

1

EXPERIMENTAL

High Dietary Protein

Behavioral: Caloric restriction, high protein; Behavioral: Nutrition Education

2

ACTIVE COMPARATOR

Normal Dietary Protein

Behavioral: Caloric restriction; normal protein; Behavioral: Nutrition Education

Interventions

Caloric restriction, high protein BEHAVIORAL

Weight loss with higher protein (35%) intake

1

Caloric restriction; normal protein BEHAVIORAL

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

2

Nutrition Education BEHAVIORAL

Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ages 18 to 70 who are undergoing gastric bypass surgery
• 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 (6)

• 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

• 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

• Riedt CS, Brolin RE, Sherrell RM, Field MP, Shapses SA. True fractional calcium absorption is decreased after Roux-en-Y gastric bypass surgery. Obesity (Silver Spring). 2006 Nov;14(11):1940-8. doi: 10.1038/oby.2006.226.

  PMID: 17135609 BACKGROUND

• 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 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 DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Caloric Restriction; Nutrition Assessment

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; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Sue A. Shapses, PhD, RD

  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, 2010
• Primary Completion: May 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

US (1)