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.
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.
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:
- 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.
- 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:
- 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.
- 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.
- 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.
- 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.
- Conditions
- Obesity, Diabetes, Hyperlipidemia
- 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 group | Role | What they receive |
|---|---|---|
| Oleic acid (OA) | Experimental | Not described Receives: Dietary Supplement: Oleic acid (OA) |
| Palmitic acid (PA) | Experimental | Not described Receives: Dietary Supplement: Palmitic Acid (PA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption
Measured: Day 29
Secondary outcomes (3)
Carbon dioxide production
Measured: Day 29
Respiratory quotient
Measured: Day 29
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.
- First posted23 Apr 2003 (estimated)
- Study startSep 2000
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- The University of Texas Medical Branch, Galveston
- Responsible party
- Sponsor
- Investigators
- Craig L Kein, MD, PhD, Principal investigator, The University of Texas Medical Branch, Galveston
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 10588958Borsheim 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Metabolism of Dietary Fatty Acids
- ClinicalTrials.gov ID
- NCT00059254
- Acronym / sponsor ID
- DMDFA (COMPLETED)
- Conditions
- Obesity, Diabetes, Hyperlipidemia
- Keywords
- fatty acids, oleic acid, palmitic acid, fat oxidation, energy expenditure, body composition, monounsaturated fat, human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- The University of Texas Medical Branch, Galveston
- Study start
- Sep 2000 (actual)
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 23 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
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:
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oleic acid (OA) | Experimental | Dietary Supplement: Oleic acid (OA) |
| Palmitic acid (PA) | Experimental | Dietary Supplement: Palmitic Acid (PA) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oleic acid (OA)OA-enriched (HI OA; fat, 40%; PA, 1.7%; OA, 31.4%) | Dietary supplement | Oleic acid (OA) |
| Palmitic Acid (PA)PA-enriched (HI PA; fat, 40% of energy; PA, 16.8%; OA, 16.4%) | Dietary supplement | Palmitic acid (PA) |
Primary outcome
Oxygen consumption
Time frame: Day 29
3 secondary outcomes
Carbon dioxide production
Time frame: Day 29
Respiratory quotient
Time frame: Day 29
excess Post exercise oxygen consumption (EPOC)
Time frame: Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Background: PubMed 10588958Schmidt 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.
- Results publication: PubMed 16919541Borsheim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig L Kein, MD, PhD principal investigator
The University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
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.