NCT00620763

Brief Summary

The impact of protein sources such as beef as part of Western diet on calcium retention remains controversial. We propose to test the hypothesis that the positive effect of high protein intake (especially from meat protein) can offset the negative effect of protein-induced net acid load on bone metabolism and the retention of body calcium. Healthy postmenopausal women recruited from the community will consume two diets differing in meat protein and acid load for 7 weeks. Calcium retention from diets will be determined using a highly sensitive measurement of whole body retention of a calcium isotope added to the diet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 3, 2009

Completed
Last Updated

July 2, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

January 18, 2008

Results QC Date

December 31, 2008

Last Update Submit

May 24, 2018

Conditions

Healthy

Keywords

Meat proteinacid loadcalcium retentionpostmenopausal women

Outcome Measures

Primary Outcomes (1)

  • Calcium Absorption

    After 3 weeks equilibration to the diet, the 2-day menu was extrinsically labeled with Calcium-47 radiotracer and retention was monitored for 28 days by whole body scintillation counting. Percent Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic plot of percent Calcium-47 retained vs time.

    18 weeks

Study Arms (2)

A

EXPERIMENTAL

Dietary Intervention: High meat and high acid load diet followed by low meat and low acid load diet

Other: High Meat - High Potential Renal Acid Load (PRAL) dietOther: Low Protein - Low Potential Renal Acid Load (PRAL) diet

B

EXPERIMENTAL

Dietary Intervention: Low meat and low acid load diet followed by high meat and high acid load diet

Other: High Meat - High Potential Renal Acid Load (PRAL) dietOther: Low Protein - Low Potential Renal Acid Load (PRAL) diet

Interventions

High Meat - High Potential Renal Acid Load (PRAL) dietOTHER

Menu high in meat protein

AB
Low Protein - Low Potential Renal Acid Load (PRAL) dietOTHER

Menu low in meat protein

AB

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Average body mass index
  • Normal blood work
  • Normal bone density

You may not qualify if:

  • Chronic disorder
  • Non-traumatic bone fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58202, United States

Location

Related Publications (2)

  • Roughead ZK, Johnson LK, Lykken GI, Hunt JR. Controlled high meat diets do not affect calcium retention or indices of bone status in healthy postmenopausal women. J Nutr. 2003 Apr;133(4):1020-6. doi: 10.1093/jn/133.4.1020.

    PMID: 12672913BACKGROUND

  • Cao JJ, Johnson LK, Hunt JR. A diet high in meat protein and potential renal acid load increases fractional calcium absorption and urinary calcium excretion without affecting markers of bone resorption or formation in postmenopausal women. J Nutr. 2011 Mar;141(3):391-7. doi: 10.3945/jn.110.129361. Epub 2011 Jan 19.

    PMID: 21248199DERIVED

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Results Point of Contact

Title
Brenda Ling
Organization
United States Department of Agriculture Grand Forks Human Nutrition Research Center
brenda.ling@ars.usda.gov
701-795-8300

Study Officials

  • Jay Cao, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2008

First Posted

February 21, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

July 2, 2018

Results First Posted

August 3, 2009

Record last verified: 2018-05

Locations

US(1)