The Effect of Severe Weight Loss and Protein Intake on Bone

Weight Loss Clinical Trial

Official title:

Nutritional Regulation of Bone - Aim 2

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00472680
• Other study ID #: AG0082
• Secondary ID: 5R01AG012161
• Status: Terminated
• Phase: N/A
• Start date: March 2010
• Est. completion date: January 2016

Study information

• Verified date: January 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

It is unclear whether the amount of protein in the diet during caloric restriction influences bone density. This information is important for determining optimal nutrient requirements during weight loss. This study will examine usual and higher dietary protein intake during severe weight loss following weight loss surgery on bone turnover, mass and quality in women, with the hypothesis that higher protein intake will reduce bone turnover and loss, and/or prevent the changes in bone quality associated with severe weight loss in women ages 18 to 70 years.

Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended level of protein intake, or B) weight loss with higher protein intake. A dietitian will provide instructions for a reduced calorie, well balanced diet throughout the 12-month study using a nutrition-education behavior- modification program. Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month. In addition they 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. 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

• Must live in the geographic vicinity of Rutgers University

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Weight Loss

Intervention

Behavioral:
• Caloric restriction, high protein
Weight loss with higher protein (35%) intake
• Caloric restriction; normal protein
Weight loss with normal level of protein (18%) intake
• Nutrition Education
Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month

Locations

Country	Name	City	State
United States	Rutgers University	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Epub 2004 Nov 29. — View Citation

Shapses SA, Riedt CS. Bone, body weight, and weight reduction: what are the concerns? J Nutr. 2006 Jun;136(6):1453-6. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Bone mineral density and quality		one year
Secondary	Changes in serum and urine bone markers, hormones, and proteins		one year