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

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ClinicalTrials.gov Identifier: NCT02634606
Recruitment Status : Terminated (Unable to obtain supplement for this study. Unable to recruit.)
First Posted : December 18, 2015
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Hypercholesterolemia
Interventions Drug: Gamma Delta Tocotrienols - Low Dose
Drug: Gamma Delta Tocotrienols - High Dose
Drug: Sugar Pill
Enrollment 13
Recruitment Details The enrollment period was 3/22/2011 - 11/13/2015 and took place in a private setting the clinic located at the site.
Pre-assignment Details 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.
Arm/Group Title Pre-Randomization
Hide Arm/Group Description 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.
Period Title: Overall Study
Started [1] 13
Completed 0
Not Completed 13
Reason Not Completed
unable to obtain the drug at start             13
[1]
13 eligible participants enrolled; none were assigned to an intervention prior to termination.
Arm/Group Title Pre-Randomization
Hide Arm/Group Description 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 Number of Baseline Participants 13
Hide Baseline Analysis Population Description
Enrolled subjects were not assigned to an intervention arm prior to study termination.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
8
  61.5%
Male
5
  38.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Change in LDL Cholesterol Over Time Between the 3 Groups
Hide Description Mixed-effects regression models will be used to evaluate the change in LDL cholesterol over time between the 3 groups
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomization was not performed prior to study termination
Arm/Group Title Gamma Delta Tocotrienols - Low Dose Gamma Delta Tocotrienols - High Dose Sugar Pill
Hide Arm/Group Description:

33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (63mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.

Gamma Delta Tocotrienols - Low Dose: 250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.

33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (127mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.

Gamma Delta Tocotrienols - High Dose: 250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.

33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the Placebo arm of the study to evaluate the cholesterol suppressive actions of Placebo. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.

Sugar Pill: 250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not reported/collected because no participants were assigned to an intervention arm prior to study termination
 
Arm/Group Title Gamma Delta Tocotrienols - Low Dose Gamma Delta Tocotrienols - High Dose Sugar Pill
Hide Arm/Group Description

33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (63mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.

Gamma Delta Tocotrienols - Low Dose: 250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.

33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (127mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.

Gamma Delta Tocotrienols - High Dose: 250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.

33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the Placebo arm of the study to evaluate the cholesterol suppressive actions of Placebo. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks.

Sugar Pill: 250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks.

All-Cause Mortality
Gamma Delta Tocotrienols - Low Dose Gamma Delta Tocotrienols - High Dose Sugar Pill
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Gamma Delta Tocotrienols - Low Dose Gamma Delta Tocotrienols - High Dose Sugar Pill
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gamma Delta Tocotrienols - Low Dose Gamma Delta Tocotrienols - High Dose Sugar Pill
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Zhaoping Li, Professor
Organization: UCLA Department of Medicine/Center for Human Nutrition
Phone: 310-206-1987 ext x61987
Responsible Party: Zhaoping Li, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02634606     History of Changes
Other Study ID Numbers: TOCO 11-000665
First Submitted: September 26, 2014
First Posted: December 18, 2015
Results First Submitted: January 23, 2019
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019