Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults

StatusCompleted
PhasePhase 2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 292 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Final enrollment: 94 participants (planned 110)
    • Primary completion date changed from estimate of Jul 31, 2027 to Mar 24, 2026
    • Eligibility criteria expanded, about 22 words
  2. 5 versions Re-verified since Aug 14, 2026, no change to tracked fieldsv287-v291
  3. Primary and study completion pushed from Jul 31, 2026 to Jul 31, 2027v286
  4. 12 versions Re-verified since Aug 30, 2025, no change to tracked fieldsv274-v285
  5. Primary and study completion dates: Jul 31, 2025 to Jul 31, 2026v273
Show 30 earlier versionsHide 30 earlier versions
  1. 9 versions Re-verified since Apr 15, 2025, no change to tracked fieldsv264-v272
  2. Study description revisedv263
  3. 4 versions Re-verified since Mar 22, 2025, no change to tracked fieldsv259-v262
  4. Study Status, Study Description, Eligibilityv258
  5. 15 versions Re-verified since Sep 7, 2024, no change to tracked fieldsv243-v257
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Omega-7 fatty acids are found in the oil extracted from certain fish and nuts like macadamia. Palmitoleic acid is one of the most common omega-7 fatty acids. Many studies suggest that this oil is good for heart health. Researchers want to find out more about these potential benefits. Objective: To study how oil enriched with palmitoleic acid (Omega-7 oil) affects metabolism. Eligibility: Healthy adults at least 18 years old with no known history of cardiovascular disease. Subjects not allergic to fish oil and fish products Females that are not pregnant and are not planning a pregnancy during the length of the study Design: Participants will be screened with questions about their health, medical history, and medicines they take. Participants will have 4 visits over 24 weeks. The visits may include: * Blood drawn from a vein in the arm by a needle stick. Sometimes participants will have to fast before the blood draw. * Vital signs (blood pressure, heart rate, and temperature) taken * Body mass index measured * Cardio-Ankle Vascular Index test may be performed. The stiffness of the participant s arteries will be measured by reading blood pressure in the arms and legs and monitoring the heart. * Optional stool samples * Pregnancy test * A short review of participants physical activity and diet * A supply of dietary supplements to take between visits. Participants will take 4 gel capsules a day. Participants will keep a food and exercise journal Compensation will be provided to subjects that complete the study Check your eligibility for this study by clicking here: https://www.surveymonkey.com/r/DietaryOmega
Trial Details
NCT Number NCT03372733
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Cardiovascular Disease
Related terms Cardiovascular Diseases
Enrollment 94 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov