NCT00059254

Brief Summary

Differences in how diet fats are converted to energy could explain some of the reported differences in health effects among different classes of dietary fat (e.g. monounsaturated vs. saturated). Recently, this laboratory showed that monounsaturated fats are turned into energy more readily than saturated fats. These results may mean that if one feeds more monounsaturated fatty acids (MUFA) and less saturated fatty acids (SFA) in the diet, body fat might accumulate at a lower rate. This could affect the risk of obesity and Type 2 Diabetes. This project has two principal Specific Aims which will be assessed in healthy young adults who are fed liquid formulas containing either an approximately equal amount of MUFA and SFA (controls) or a much greater amount of MUFA and much less SFA:

  1. 1.To determine if a higher intake of MUFA and a reciprocally lower intake of SFA is associated with a higher rate of fat oxidation. We hypothesize that the rate of fat oxidation after eating will be higher in those subjects randomized to the MUFA-enriched diet compared to controls.
  2. 2.To measure energy intake required to maintain constant body weight during each diet and to measure fat-free mass and fat mass, before and after each dietary change. We hypothesize that those on the high MUFA diet will need a higher energy intake required to maintain constant body weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2000

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

September 1, 2000

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

4.6 years

First QC Date

April 22, 2003

Last Update Submit

October 11, 2017

Conditions

ObesityDiabetesHyperlipidemia

Keywords

fatty acidsoleic acidpalmitic acidfat oxidationenergy expenditurebody compositionmonounsaturated fathuman

Outcome Measures

Primary Outcomes (1)

  • Oxygen consumption

    Day 29

Secondary Outcomes (3)

  • Carbon dioxide production

    Day 29

  • Respiratory quotient

    Day 29

  • excess Post exercise oxygen consumption (EPOC)

    Day 29

Study Arms (2)

Oleic acid (OA)

EXPERIMENTAL
Dietary Supplement: Oleic acid (OA)

Palmitic acid (PA)

EXPERIMENTAL
Dietary Supplement: Palmitic Acid (PA)

Interventions

Oleic acid (OA)DIETARY_SUPPLEMENT

OA-enriched (HI OA; fat, 40%; PA, 1.7%; OA, 31.4%)

Oleic acid (OA)
Palmitic Acid (PA)DIETARY_SUPPLEMENT

PA-enriched (HI PA; fat, 40% of energy; PA, 16.8%; OA, 16.4%)

Palmitic acid (PA)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
* Healthy young adults, ages 18-35 yr. .: Generally, this means that the subject is not being continually treated with medication (possible exceptions include thyroid replacement therapy and some allergy treatments). * Must avoid pregnancy during the study duration (we will test for this as part of the protocol). * Must avoid use of drugs that may affect lipid metabolism, including caffeine and nicotine.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Utmb Gcrc

Galveston, Texas, 77555, United States

Location

Related Publications (2)

  • Schmidt DE, Allred JB, Kien CL. Fractional oxidation of chylomicron-derived oleate is greater than that of palmitate in healthy adults fed frequent small meals. J Lipid Res. 1999 Dec;40(12):2322-32.

    PMID: 10588958BACKGROUND

  • Borsheim E, Kien CL, Pearl WM. Differential effects of dietary intake of palmitic acid and oleic acid on oxygen consumption during and after exercise. Metabolism. 2006 Sep;55(9):1215-21. doi: 10.1016/j.metabol.2006.05.005.

    PMID: 16919541RESULT

MeSH Terms

Conditions

ObesityDiabetes MellitusHyperlipidemias

Interventions

Oleic AcidPalmitic Acid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Oleic AcidsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipidsPalmitic Acids

Study Officials

  • Craig L Kein, MD, PhD

    The University of Texas Medical Branch, Galveston

    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
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2003

First Posted

April 23, 2003

Study Start

September 1, 2000

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

US(1)