NCT01612234

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

5.6 years

First QC Date

May 29, 2012

Last Update Submit

November 30, 2015

Conditions

Keywords

humansleanobesesaturated fatmonounsaturated fatinsulin sensitivityinflammationoxidant stress

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.

EXPERIMENTAL

This 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.

Dietary Supplement: High palmitate or high oleate diet.

high palmitate or high oleate diet

EXPERIMENTAL

This 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.

Dietary Supplement: High palmitate or high oleate diet.

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

High palmitate or high oleate diet.high palmitate or high oleate diet

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 20559306BACKGROUND
  • Kien 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: 24429541BACKGROUND
  • Kien 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.

  • Kien 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.

  • Kien 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.

  • Kien 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.

Related Links

MeSH Terms

Conditions

ObesityInsulin ResistanceInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesPathologic Processes

Study Officials

  • Craig L. Kien, M.D, Ph.D.

    The University of Vermont

    PRINCIPAL INVESTIGATOR

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

Locations