Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults
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|ClinicalTrials.gov Identifier: NCT03372733|
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : January 13, 2020
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.
To study how oil enriched with palmitoleic acid (Omega-7 oil) affects metabolism.
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
Participants will be screened with questions about their health, medical history, and medicines they take.
Participants will have 4 visits over 24 30 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. 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
- Appetite and satiety test. Participants will fast the night before, then answer questions about appetite and feeling full. They will get a light breakfast and then a light lunch.
- 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
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Drug: control olive oil (COO) Drug: palmitoleate-rich oil (PLO)||Phase 2|
Serum cholesterol is transported by lipoproteins, such as VLDL, LDL and HDL, which vary in their relationship to cardiovascular disease risk. LDL, for example, is proatherogenic, whereas HDL is cardio-protective. Palmitoleic acid (cis-C16:1 n-7), an omega-7 fatty acid with 16 carbons in length with a single double bound in the n-7 position, have been shown in mice and human to decrease proatherogenic lipoproteins, such as LDL, and reduce cardiovascular risk factors. This study will test the hypothesis that palmitoleate supplementation in humans will favorably alter the lipoprotein lipid profile in regard to cardiovascular disease risk. We will also assess other parameters related to lipoprotein composition and function, as well as other biomarkers related to coagulation and inflammation, which have previously been shown to be possibly affected by supplementation with omega-7 fatty acid. In addition, previous animal studies have indicated the palmitoleate induced satiety and suppressed bodyweight gain, possibly through enhancement of the release of satiety hormones. In this clinical trial, we, therefore will also examine the effect of concentrated palmitoleate on satiety.
This clinical research project is designed as a pilot, randomized, double-blinded, crossover study that will investigate the effect of concentrated oil enriched with palmitoleate on lipoprotein metabolism and satiety. Subjects will either receive control olive oil enriched in oleic acid, a longer-chain monounsaturated fatty acid (cis-C18:1 n-9), or a concentrate oil supplement produced from pollock fish (rich in palmitoleate) for approximately 8-10 weeks, with a wash out period of 8-10 weeks between the two arms of the study. The study consists of 4 outpatient visits when laboratory or research samples and CAVI tests will be performed. A 7-day food diary, pill count, and red cell membrane fatty acid levels will be monitored to assess compliance. The effect of the supplement on satiety will be assessed at each visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults|
|Actual Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Experimental: Group 1
Subjects randomized to the control olive oil armwill take the equivalant to 3g of control /day in twodivided doses (4 capsules a day) for 8 +/- 2 weeks andcross-over to the palmitoleate-rich oil
Drug: control olive oil (COO)
2 capsules, 2 times a day after meals in a total of 4 capsules a day
Experimental: Group 2
Subjects randomized to the Subjects randomizedto the control olive oil arm will take the equivalant to3g of control /day in two divided doses (4 capsulesa day) for 8 +/- 2 weeks and cross-over to thepalmitoleate-rich oil arm will take the equivalant to3g of control /day in two divided doses (4 capsulesa day) for 8 +/- 2 weeks and cross-over to the contrololive oil
Drug: palmitoleate-rich oil (PLO)
2 capsules, 2 times a day after meals in a total of 4 capsules a day
- Changes in the LDL-cholesterol levels [ Time Frame: 24 weeks ]The primary outcome measures of this study will be changes in the LDL- cholesterol levels. Secondary outcome measurements will be changes in TC, TG, HDL-C, and other lipids, lipoprotein particle number, HDL functional test (i.e. efflux study) composition and size, changes in appetite and/or satiety. Each subject will serve as their own control.
- Changes in TC, TG, HDL-C, and other lipids, lipoprotein particle number, HDL functional test (i.e. efflux study) composition and size,changes in apetite and/or satiety [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372733
|Contact: OPR Office of Patient Recruitment||Not Listedemail@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Marcelo J Amar, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|