Saturated Fat Versus Monounsaturated Fat and Insulin Action
Palmitate Metabolism and Insulin Resistance
1 other identifier
interventional
70
1 country
1
Brief Summary
High intakes of saturated fat are associated with diabetes. Our work has shown that the two most common fatty acids in the North American diet, palmitic acid (saturated fat) and oleic acid (monounsaturated fat) are metabolized differently and have opposite effects on fat burning. The proposed study will examine biochemical and molecular mechanisms for how a high saturated fat diet versus a low saturated fat/high monounsaturated fat diet alters the action of the hormone, insulin, in skeletal muscle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Apr 2010
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 29, 2012
CompletedFirst Posted
Study publicly available on registry
June 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 2, 2015
November 1, 2015
5.6 years
May 29, 2012
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Whether increased palmitate balance (as measured by intake and the rate of [1-13C]-PA oxidation) causes increased insulin resistance and increased inflammatory signaling by peripheral blood mononuclear cells
Insulin sensitivity, inflammatory signaling, palmitate balance, and incomplete oxidation of palmitate in lean and obese young adults.
up to 4 yr
Secondary Outcomes (1)
We will examine the link between palmitate intake and balance and oxidative stress measured using muscle and peripheral blood markers of oxidative stress and antioxidant responses.
up to 4 yr
Study Arms (2)
High palmitate or high oleate diet.
EXPERIMENTALThis is a solid food diet in which vegetable oils are used to create a dietary fat composition similar to the average American/Western diet in which palmitic and oleic acid are ingested in approximately equal amounts (high palmitate diet) or a composition similar to the Mediterranean Diet (low palmitate, high oleate, using hazelnut oil as the source of fat). There are no interventions other than the diet itself.
high palmitate or high oleate diet
EXPERIMENTALThis is a solid food diet in which vegetable oils are used to create a dietary fat composition similar to the average American/Western diet in which palmitic and oleic acid are ingested in approximately equal amounts (high palmitate diet) or a composition similar to the Mediterranean Diet (low palmitate, high oleate, using hazelnut oil as the source of fat). There are no interventions other than the diet itself.
Interventions
High palmitate diet composition: Fat, 40.4% kcal; palmitic acid, 16.0% kcal; oleic acid,16.2% kcal. High oleate diet composition: Fat, 40.1% kcal; palmitic acid, 2.4% kcal; oleic acid, 28.8% kcal
Eligibility Criteria
You may qualify if:
- healthy young adults,
- years of age
You may not qualify if:
- regular aerobic exercise training,
- dyslipidemia, and
- type 2 diabetes or insulin resistance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Unversity of Vermont Clinical Research Center at Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Related Publications (6)
Kien CL, Everingham KI, D Stevens R, Fukagawa NK, Muoio DM. Short-term effects of dietary fatty acids on muscle lipid composition and serum acylcarnitine profile in human subjects. Obesity (Silver Spring). 2011 Feb;19(2):305-11. doi: 10.1038/oby.2010.135. Epub 2010 Jun 17.
PMID: 20559306BACKGROUNDKien CL, Bunn JY, Stevens R, Bain J, Ikayeva O, Crain K, Koves TR, Muoio DM. Dietary intake of palmitate and oleate has broad impact on systemic and tissue lipid profiles in humans. Am J Clin Nutr. 2014 Mar;99(3):436-45. doi: 10.3945/ajcn.113.070557. Epub 2014 Jan 15.
PMID: 24429541BACKGROUNDKien CL, Bunn JY, Tompkins CL, Dumas JA, Crain KI, Ebenstein DB, Koves TR, Muoio DM. Substituting dietary monounsaturated fat for saturated fat is associated with increased daily physical activity and resting energy expenditure and with changes in mood. Am J Clin Nutr. 2013 Apr;97(4):689-97. doi: 10.3945/ajcn.112.051730. Epub 2013 Feb 27.
PMID: 23446891RESULTKien CL, Bunn JY, Poynter ME, Stevens R, Bain J, Ikayeva O, Fukagawa NK, Champagne CM, Crain KI, Koves TR, Muoio DM. A lipidomics analysis of the relationship between dietary fatty acid composition and insulin sensitivity in young adults. Diabetes. 2013 Apr;62(4):1054-63. doi: 10.2337/db12-0363. Epub 2012 Dec 13.
PMID: 23238293RESULTKien CL, Matthews DE, Poynter ME, Bunn JY, Fukagawa NK, Crain KI, Ebenstein DB, Tarleton EK, Stevens RD, Koves TR, Muoio DM. Increased palmitate intake: higher acylcarnitine concentrations without impaired progression of beta-oxidation. J Lipid Res. 2015 Sep;56(9):1795-807. doi: 10.1194/jlr.M060137. Epub 2015 Jul 8.
PMID: 26156077RESULTKien CL, Bunn JY, Fukagawa NK, Anathy V, Matthews DE, Crain KI, Ebenstein DB, Tarleton EK, Pratley RE, Poynter ME. Lipidomic evidence that lowering the typical dietary palmitate to oleate ratio in humans decreases the leukocyte production of proinflammatory cytokines and muscle expression of redox-sensitive genes. J Nutr Biochem. 2015 Dec;26(12):1599-606. doi: 10.1016/j.jnutbio.2015.07.014. Epub 2015 Aug 1.
PMID: 26324406RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Craig L. Kien, M.D, Ph.D.
The University of Vermont
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The Mary Kay Davignon Green and Gold Professor, Depts. of Pediatrics and Medicine
Study Record Dates
First Submitted
May 29, 2012
First Posted
June 5, 2012
Study Start
April 1, 2010
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
December 2, 2015
Record last verified: 2015-11