Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?

This study has been completed.

Sponsor:

Collaborator:

National Cattlemen's Beef Association

Information provided by:

USDA Grand Forks Human Nutrition Research Center

ClinicalTrials.gov Identifier:

NCT00700804

First received: June 18, 2008

Last updated: May 31, 2011

Last verified: May 2011

History of Changes

Results First Received: December 30, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-availability Study; Intervention Model: Factorial Assignment; Masking: Open Label; Primary Purpose: Basic Science
Condition:	Dietary Proteins
Interventions:	Behavioral: High Protein Diet Behavioral: Low Protein Diet

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Post menopausal women willing to eat controlled diet at United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center for 14 weeks

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were assigned to either the High or Low Calcium diets. The subjects then consumed the high and low protein diets in random order, i.e. half of the subjects consumed high protein, then low protein while the other half consumed low protein, then the high protein diet. Drop-outs were replaced.

Reporting Groups

	Description
High Calcium Diet	Women consumed diets containing 1500 milligrams of calcium daily
Low Calcium Diet	Women consumed diets containing 600 milligrams of calcium daily

Participant Flow: Overall Study

	High Calcium Diet	Low Calcium Diet
STARTED	17	17
COMPLETED	14	13
NOT COMPLETED	3	4
Withdrawal by Subject	1	2
Protocol Violation	1	1
Loose Stools	1	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
High Calcium Diet	Women consumed diets containing 1500 milligrams of calcium daily
Low Calcium Diet	Women consumed diets containing 600 milligrams of calcium daily
Total	Total of all reporting groups

Baseline Measures

	High Calcium Diet	Low Calcium Diet	Total
Number of Participants [units: participants]	17	17	34
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	16	14	30
>=65 years	1	3	4
Age [units: years] Mean ± Standard Deviation	57 ± 5	58 ± 6	57 ± 5
Gender [units: participants]
Female	17	17	34
Male	0	0	0

Outcome Measures

Show All Outcome Measures

1. Primary:

Calcium Absorption [ Time Frame: 17 weeks ]

Show Outcome Measure 1

2. Secondary:

Serum Insulin-like Growth Factor 1 (IGF-1) [ Time Frame: 7 weeks ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Janet Hunt, PhD
Organization: United States Department of Agriculture (USDA) Grand Forks Human Nutrition Reserch Center
phone: 701-795-8353
e-mail: janetrhunt@gmail.com

No publications provided

Responsible Party:	Janet R Hunt, PhD, Research Nutritionist, United States Department of Agriculture (USDA) Grand Forks Human Nutriton Research Center
ClinicalTrials.gov Identifier:	NCT00700804 History of Changes
Other Study ID Numbers:	GFHNRC064, IRB-200307-010
Study First Received:	June 18, 2008
Results First Received:	December 30, 2008
Last Updated:	May 31, 2011
Health Authority:	United States: Federal Government United States: Institutional Review Board United States: Food and Drug Administration

To Top