Trial Outcomes & Findings for Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically? (NCT NCT00700804)

Results Overview

Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

17 weeks

Results posted on

2018-07-02

Participant Flow

Post menopausal women willing to eat controlled diet at United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center for 14 weeks

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.

Participant milestones

Participant milestones
Measure	High Calcium Diet Women consumed diets containing 1500 milligrams of calcium daily	Low Calcium Diet Women consumed diets containing 600 milligrams of calcium daily
Overall Study STARTED	17	17
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	High Calcium Diet Women consumed diets containing 1500 milligrams of calcium daily	Low Calcium Diet Women consumed diets containing 600 milligrams of calcium daily
Overall Study Withdrawal by Subject	1	2
Overall Study Protocol Violation	1	1
Overall Study Loose Stools	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Calcium Diet n=17 Participants Women consumed diets containing 1500 milligrams of calcium daily	Low Calcium Diet n=17 Participants Women consumed diets containing 600 milligrams of calcium daily	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	14 Participants n=4 Participants	30 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Age, Continuous	57 years STANDARD_DEVIATION 5 • n=93 Participants	58 years STANDARD_DEVIATION 6 • n=4 Participants	57 years STANDARD_DEVIATION 5 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	17 Participants n=4 Participants	34 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 17 weeks

Population: Only participants which completed both protein diet periods were included in the statistical analysis

Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time

Outcome measures

Outcome measures
Measure	High Calcium Diet n=14 Participants Women consumed diets containing 1500 milligrams of calcium daily	Low Calcium Diet n=13 Participants Women consumed diets containing 600 milligrams of calcium daily
Calcium Absorption High Protein Diet	18.1 percentage of Calcium absorbed Standard Deviation 2.5	29.5 percentage of Calcium absorbed Standard Deviation 2.5
Calcium Absorption Low Protein Diet	18.0 percentage of Calcium absorbed Standard Deviation 2.5	26 percentage of Calcium absorbed Standard Deviation 2.5

SECONDARY outcome

Timeframe: 7 weeks

Outcome measures

Outcome measures
Measure	High Calcium Diet n=14 Participants Women consumed diets containing 1500 milligrams of calcium daily	Low Calcium Diet n=13 Participants Women consumed diets containing 600 milligrams of calcium daily
Serum Insulin-like Growth Factor 1 (IGF-1) High Protein Diet	5.23 nanomoles per liter (nmols/L) Standard Error 0.12	5.07 nanomoles per liter (nmols/L) Standard Error 0.12
Serum Insulin-like Growth Factor 1 (IGF-1) Low Protein Diet	4.96 nanomoles per liter (nmols/L) Standard Error 0.12	4.87 nanomoles per liter (nmols/L) Standard Error 0.12

Adverse Events

High Calcium Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Calcium Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Janet Hunt, PhD

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

Phone: 701-795-8353

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place