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ObesityNCT00059254

Differential Metabolism of Dietary Fatty Acids

A study testing Oleic acid (OA) and Palmitic Acid (PA) in people with Obesity and Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Diabetes, Hyperlipidemia
What is being tested?
Oleic acid (OA) and Palmitic Acid (PA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
Sep 2000to Apr 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Utmb Gcrc

    Galveston, Texas, 77555

Other trials in United States

About this study

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. 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. 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.
Read the detailed description

Our Preliminary Data indicate that the rate of oleic acid (OA) oxidation (amount/unit time) is 21% increased compared to palmitic acid (PA) when both fatty acids are fed to the same person at the same intake. We hypothesize that if the ratio of OA to PA in the diet were to increase, the rate of total fatty acid oxidation in the fed state also would increase under the same metabolic conditions. If our principal hypothesis is correct, overall daily fat balance might be decreased in humans fed diets enriched in OA. This would have potential significance to the treatment and prevention of obesity.

In order to address this hypothesis, we propose the following double-masked, randomized control trial. Indirect calorimetry will be performed in the fed and fasting state in young, healthy adults who will be studied under two conditions: after a 30-day, supervised, solid food diet and then again after a 30-day formula diet. The subjects will be randomized to receive either a Control Formula Diet of the same macronutrient and fatty acid composition as the solid food diet (OA=PA=16.4% total kcal) or a High Oleic Acid Formula Diet (OA=31.4% total kcal and PA=1.7% total kcal). The Control Diets (solid and liquid) provide amounts (per kcal) of total fat, saturated fat, and OA that are similar to the to the 50-75th percentile of intake of young adult Americans but above the intake of total fat and saturated fat that is recommended for optimal long-term health. The High OA Formula Diet is designed to simulate the fat source of the Mediterranean Diet. The High OA diet will result in a 167% increase in the intake/kcal of OA in the sn-1 and sn-3 positions of the dietary triacylglycerol. Using dual-energy x-ray absorptiometry (DEXA), we will monitor body composition before and after each diet, while adjusting energy intake to maintain constant body weight. The following Specific Aims will be addressed:

  1. To determine if a higher intake of oleic acid (and a reciprocally lower intake of palmitic acid) is associated with a higher rate of fat oxidation. We hypothesize that the rate of fat oxidation (g/hr) in the fed state, adjusted for the covariate effect of the rate of fat oxidation on the solid food diet, will be higher (>30%) in those subjects randomized to the OA-enriched diet compared to controls. Furthermore, we hypothesize that fat oxidation will not be higher when expressed as a proportion of energy expenditure in the OA-enriched formula group. That is, we expect energy expenditure in the fed state to be higher in those fed the OA-enriched diet.
  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 a higher rate of fat oxidation on the high OA diet will be associated with a higher energy intake required to maintain constant body weight.
  3. To compare fat oxidation on the liquid formula diet with that observed on the solid food diet. We hypothesize that fat oxidation will increase in those fed the OA-enriched diet.
  4. To measure the thermic effect of feeding during both the solid food and formula diet periods. We hypothesize that the high OA feeding will be associated with a higher thermic effect of feeding.
Being tested
Oleic acid (OA), Palmitic Acid (PA)
Keywords
fatty acids, oleic acid, palmitic acid, fat oxidation, energy expenditure, body composition, monounsaturated fat, human
Medical subject headings
Obesity, Diabetes Mellitus, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oleic acid (OA)Dietary supplement

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

  • Palmitic Acid (PA)Dietary supplement

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

Study groups in NCT00059254
Study groupRoleWhat they receive
Oleic acid (OA)ExperimentalNot described
Receives: Dietary Supplement: Oleic acid (OA)
Palmitic acid (PA)ExperimentalNot described
Receives: Dietary Supplement: Palmitic Acid (PA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygen consumption

    Measured: Day 29

Secondary outcomes (3)
  1. Carbon dioxide production

    Measured: Day 29

  2. Respiratory quotient

    Measured: Day 29

  3. excess Post exercise oxygen consumption (EPOC)

    Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2003 (estimated)
  2. Study startSep 2000
  3. Primary completionApr 2005
  4. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00059254
Sponsor's protocol ID
DMDFA (COMPLETED)
Other IDs
R01DK055384
Status last verified
Oct 2017
First submitted
22 Apr 2003
Last updated
12 Oct 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 10588958
  • 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.

    PubMed 16919541

Questions about this trial

What is this clinical trial studying?

A study testing Oleic acid (OA) and Palmitic Acid (PA) in people with Obesity and Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen consumption (time frame: Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00059254, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.

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