Trial Outcomes & Findings for Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia (NCT NCT01034540)

Last Updated: 2024-05-30

Results Overview

Liquid meal tolerance test (LMTT) = two 8 oz servings of Ensure (Abbott Nutrition) + study product followed by blood sample collection at -5, -1, 30, 60, 90, 120, 180, and 240 min, where t = 0 was start of liquid meal consumption. MISI calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin)

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)

Results posted on

2024-05-30

Participant Flow

Recruitment was conducted using the research clinic database and print advertisements. First subject screened in May 2010 and screening ended in August 2010.

Participant milestones

Participant milestones
Measure	Prescription Omega-3 Acid Ethyl Esters/Placebo Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the first six weeks of treatment. Placebo (corn oil 4 g/d) for the second six weeks of treatment	Placebo/Prescription Omega-3 Acid Ethyl Esters Placebo (corn oil 4 g/d) for the first six weeks of treatment. Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the second six weeks of treatment
Overall Study STARTED	11	12
Overall Study Completed 1st Treatment Intervention	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Prescription Omega-3 Acid Ethyl Esters/Placebo Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the first six weeks of treatment. Placebo (corn oil 4 g/d) for the second six weeks of treatment	Placebo/Prescription Omega-3 Acid Ethyl Esters Placebo (corn oil 4 g/d) for the first six weeks of treatment. Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the second six weeks of treatment
Overall Study Adverse Event	0	1

Baseline Characteristics

Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prescription Omega-3 Acid Ethyl Esters (POM3)/Placebo n=11 Participants POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment	Placebo/Prescription Omega-3 Acid Ethyl Esters (POM3) n=12 Participants Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment	Total n=23 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	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Age, Continuous	47.9 years STANDARD_DEVIATION 5.0 • n=93 Participants	60.0 years STANDARD_DEVIATION 1.7 • n=4 Participants	54.2 years STANDARD_DEVIATION 2.8 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	8 Participants n=4 Participants	11 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment United States	11 participants n=93 Participants	12 participants n=4 Participants	23 participants n=27 Participants

PRIMARY outcome

Timeframe: End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)

Population: Per protocol population in which subjects with poor compliance, protocol violations, and without at least one post-randomization outcome data point during each treatment intervention period were removed.

Outcome measures

Outcome measures
Measure	Control n=19 Participants Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.	Prescription Omega-3 Acid Ethyl Esters n=19 Participants Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).	3.2 Index value Interval 1.9 to 7.1	3.3 Index value Interval 2.0 to 7.4

SECONDARY outcome

Timeframe: End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)

Population: Per protocol population excluding subjects with poor compliance and protocol violations.

Insulin secretion index = total area under the curve from 0 to 120 min post-meal for plasma insulin divided by total area under the curve from 0 to 120 min post-meal for plasma glucose. Disposition index = MISI x insulin secretion index

Outcome measures

Outcome measures
Measure	Control n=19 Participants Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.	Prescription Omega-3 Acid Ethyl Esters n=19 Participants Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. Disposition index	2.4 Index value Standard Error 0.25	2.1 Index value Standard Error 0.20
Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. Insulin secretion index	0.73 Index value Standard Error 0.09	0.66 Index value Standard Error 0.09

Adverse Events

POM3

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

John Marshall, General Manager

Biofortis Clinical Research (formerly Provident)

Phone: 630-748-5339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	POM3 n=23 participants at risk Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.	Placebo n=23 participants at risk Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
General disorders Allergy aggravated	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Nervous system disorders Headache	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Gastrointestinal disorders Diarrhea	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Gastrointestinal disorders Gastroesophageal reflux	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Hepatobiliary disorders SGOT Increased	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Hepatobiliary disorders SGPT Increased	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	13.0% 3/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Blood and lymphatic system disorders Purpura	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Infections and infestations Bronchitis	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Infections and infestations Pharyngitis	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Infections and infestations Sinusitis	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	8.7% 2/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Injury, poisoning and procedural complications Decubitus Ulcer	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Injury, poisoning and procedural complications Laceration	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)
Eye disorders Ocular Hemorrhage	0.00% 0/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)	4.3% 1/23 • 14 weeks Adverse event analyses reported for safety population (all randomized subjects who consumed at least 1 dose of study product)