Trial Outcomes & Findings for Supplements for Controlling Resistance to Insulin (NCT NCT00699413)

Results Overview

Change in Body Mass Index measurement at baseline and 12 weeks

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

measured at baseline and 12 weeks

Results posted on

2024-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Arm nutrition education plus active supplement	Control Arm nutrition education plus inactive supplement
Overall Study STARTED	4	4
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Arm nutrition education plus active supplement	Control Arm nutrition education plus inactive supplement
Overall Study Withdrawal by Subject	0	2
Overall Study Study terminated by sponsor	4	2

Baseline Characteristics

Supplements for Controlling Resistance to Insulin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=4 Participants nutrition education plus active supplement	Control Arm n=2 Participants nutrition education plus inactive supplement	Total n=6 Participants Total of all reporting groups
Age, Continuous	15 years STANDARD_DEVIATION 1.41 • n=5 Participants	14 years STANDARD_DEVIATION 1 • n=7 Participants	14.6 years STANDARD_DEVIATION 1.37 • n=5 Participants
Age, Customized <=18 years	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: measured at baseline and 12 weeks

Population: Data were not collected. Previously reported data were incorrect and do not reflect a change in BMI from baseline to 12 weeks. Only basic demographic information was collected at baseline and no outcome measures were captured. The study was terminated prior to the 12 week intervention end and no data were collected at the second time point.

Change in Body Mass Index measurement at baseline and 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline and 12 weeks

Population: Data were not collected

Change in insulin activity measured at baseline and 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline and 12 weeks

Population: Data were not collected

Change in percent body fat measured at baseline and 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline and 12 weeks

Population: Data were not collected

Change in hunger score using Likert scale measured at baseline and 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

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

Michael Goran

USC

Phone: 323.442.3027

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place