Trial Outcomes & Findings for Effects of a Supplement Derived From Palm Oil on Cholesterol Levels in the Blood (NCT NCT02634606)

Results Overview

Mixed-effects regression models will be used to evaluate the change in LDL cholesterol over time between the 3 groups

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

13 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2019-02-12

Participant Flow

The enrollment period was 3/22/2011 - 11/13/2015 and took place in a private setting the clinic located at the site.

Thirteen subjects with cholesterol level (\>180 mg/dl), aged 37-64, taking statins drug at the time were to be assigned to the low dose arm (TRF 63 mg), high dose arm (RTF 127 mg) or control (sugar pill) for 12 weeks. Randomization was not performed due to limited subjects recruited.

Participant milestones

Participant milestones
Measure	Pre-Randomization Thirteen enrolled subjects were to be assigned to the low dose arm (TRF 63 mg), high dose arm (RTF 127 mg) or control (sugar pill). Randomization was not performed prior to study termination.
Overall Study STARTED	13
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Pre-Randomization Thirteen enrolled subjects were to be assigned to the low dose arm (TRF 63 mg), high dose arm (RTF 127 mg) or control (sugar pill). Randomization was not performed prior to study termination.
Overall Study unable to obtain the drug at start	13

Baseline Characteristics

Effects of a Supplement Derived From Palm Oil on Cholesterol Levels in the Blood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-Randomization n=13 Participants Thirteen enrolled subjects were to be assigned to the low dose arm (TRF 63 mg), high dose arm (RTF 127 mg) or control (sugar pill). Randomization was not performed prior to study termination.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Randomization was not performed prior to study termination

Mixed-effects regression models will be used to evaluate the change in LDL cholesterol over time between the 3 groups

Outcome measures

Outcome data not reported

Adverse Events

Gamma Delta Tocotrienols - Low Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gamma Delta Tocotrienols - High Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

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

Zhaoping Li, Professor

UCLA Department of Medicine/Center for Human Nutrition

Phone: 310-206-1987

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place