Trial Outcomes & Findings for The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet (NCT NCT00138645)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

April 2005 to May 2006

Results posted on

2016-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	MicroDiet MicroDiet	Healthy Diet Healthy Diet
Overall Study STARTED	30	30
Overall Study COMPLETED	24	23
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MicroDiet n=30 Participants MicroDiet	Healthy Diet n=30 Participants Healthy Diet	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40 years STANDARD_DEVIATION 11.4 • n=5 Participants	43 years STANDARD_DEVIATION 11.4 • n=7 Participants	42 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: April 2005 to May 2006

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 weeks

Percent change in body weight from baseline to week 24(completers).

Outcome measures

Outcome measures
Measure	MicroDiet n=24 Participants MicroDiet	Healthy Diet n=23 Participants Healthy Diet
Percent Change in Body Weight (Completers).	7.3 change in percent:baseline body weight Standard Error 1.3	7.0 change in percent:baseline body weight Standard Error 1.3

SECONDARY outcome

Timeframe: April 2005 to May 2006

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: April 2005 to May 2006

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: April 2005 to May 2006

Outcome measures

Outcome data not reported

Adverse Events

MicroDiet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy 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

Corby K. Martin, Ph.D.; Assistant Professor

Pennington Biomedical Research Center

Phone: 225-763-2585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place