InflammationNCT02246933
Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses
A study testing PUFA Diet in people with Inflammation and Obesity, run by University of Georgia at 1 site in United States.
Trial summary
This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation responses. Half of the participants will receive a high polyunsaturated fat diet )50% carbohydrate, 15% protein, and 35% fat. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Obesity
- What is being tested?
- PUFA Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Aug 2015
- 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
Who may be able to join
- Apparently healthy men and women between the ages of 18 and 45y with a normal weight based on body mass index (BMI=18-24.9kg/m2), must be sedentary (perform less than 3 hours per week of structured exercise) and , if participant has fasting total cholesterol >200 gm/dL, high-density lipoprotein <40 mg/dL, low-density lipoprotein cholesterol >100 mg/dL, and/or triglycerides >150 mg/dL (based on fasting blood lipids).
Who cannot join
- Weight loss or gain exceeding 5% of body weight in the past 3 months
- Current participation in a weight loss program
- Any current exercisers (greater than 3h per week)
- Any person who is on a medically prescribed diet
- Any person who is vegan, or any type of vegetarian other than pesco-vegetarian
- Any chronic or metabolic disease, hyperlipidemia, gastrointestinal disorder, or history of medical or surgical events that could affect digestion and absorption of nutrients
Show all 13Show fewer
- Any current supplement use other than a daily multivitamin (this includes fish oil supplements)
- Any current medication use other than birth control (this includes anti-inflammatory NSAID use).
- Anyone who is pregnant, lactating, or planning a pregnancy
- Anyone who has donated blood or plasma in the last 20 days
- Any tobacco users
- Anyone who has allergies to the most common food allergens (milk, eggs, peanuts, almonds, cashews, walnuts, fish, shellfish, soy and wheat) or to any of the food that will provided during the study
- Anyone who has allergies to any of the components of the liquid meals
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Georgia - Department of Foods and Nutrition
Athens, Georgia, 30602
About this study
This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation responses. Half of the participants will receive a high polyunsaturated fat diet )50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50% carbohydrate, 35% fat, and 15% protein. Only, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids.) for 7 days.
Read the detailed description
Eating more saturated fats has been shown to decrease how many calories an individual burns and increase chronic disease risk by increasing inflammation, coagulation (blood clotting) potential, blood pressure, and cholesterol. Conversely, eating more poly-unsaturated fats has been linked to decreased risk of chronic diseases. The goal of this study is to determine whether or not eating a diet containing a lot of poly-unsaturated fats can compensate for the damaging effects of eating occasional high-fat meals that are high in saturated fats. Those damaging effects we are interested in studying include how much fat and calories a person's body burns, and measuring some markers of chronic disease risk in the blood (inflammation markers and blood clotting markers).
- Conditions
- Inflammation, Obesity
- Being tested
- PUFA Diet, Control Diet
- Medical subject headings
- Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUFA DietOther
The 7-day diet will consist of 50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids.
Control DietOther
The 7-day diet will consist of 50% carbohydrate, 35% fat, and 15% protein. Furthermore, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids.
| Study group | Role | What they receive |
|---|---|---|
| PUFA Diet | Experimental | Not described Receives: Other: PUFA Diet |
| Control Diet | Placebo comparator | Not described Receives: Other: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Markers
Change in inflammation and coagulation factors
Measured: Change measures baseline and 9 days
Secondary outcomes (4)
Change in Energy Expenditure
Measured: Change measures baseline and 9 days
Change in Substrate Oxidation
Measured: Change measures baseline and 9 days
Change in Fasting Blood Lipids
Measured: Change measures baseline and 9 days
Change in Systolic Blood Pressure
Measured: Change measures baseline and 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Cooper, University of Georgia
- Investigators
- jamie A Cooper, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246933
- Sponsor's protocol ID
- 503815
- Status last verified
- Oct 2015
- First submitted
- 18 Sep 2014
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaviani S, Taylor CM, Stevenson JL, Cooper JA, Paton CM. A 7-day high-PUFA diet reduces angiopoietin-like protein 3 and 8 responses and postprandial triglyceride levels in healthy females but not males: a randomized control trial. BMC Nutr. 2019 Jan 6;5:1. doi: 10.1186/s40795-018-0262-7. eCollection 2019.
PubMed 32153916
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses
- ClinicalTrials.gov ID
- NCT02246933
- Acronym / sponsor ID
- 503815
- Conditions
- Inflammation, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Sep 2014 (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.
This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation responses. Half of the participants will receive a high polyunsaturated fat diet )50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50% carbohydrate, 35% fat, and 15% protein. Only, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids.) for 7 days.
Detailed description
Eating more saturated fats has been shown to decrease how many calories an individual burns and increase chronic disease risk by increasing inflammation, coagulation (blood clotting) potential, blood pressure, and cholesterol. Conversely, eating more poly-unsaturated fats has been linked to decreased risk of chronic diseases. The goal of this study is to determine whether or not eating a diet containing a lot of poly-unsaturated fats can compensate for the damaging effects of eating occasional high-fat meals that are high in saturated fats. Those damaging effects we are interested in studying include how much fat and calories a person's body burns, and measuring some markers of chronic disease risk in the blood (inflammation markers and blood clotting markers).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PUFA Diet | Experimental | Other: PUFA Diet |
| Control Diet | Placebo comparator | Other: Control Diet |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Apparently healthy men and women between the ages of 18 and 45y with a normal weight based on body mass index (BMI=18-24.9kg/m2), must be sedentary (perform less than 3 hours per week of structured exercise) and , if participant has fasting total cholesterol >200 gm/dL, high-density lipoprotein <40 mg/dL, low-density lipoprotein cholesterol >100 mg/dL, and/or triglycerides >150 mg/dL (based on fasting blood lipids).
Key exclusion criteria (13 listed)
- Weight loss or gain exceeding 5% of body weight in the past 3 months
- Current participation in a weight loss program
- Any current exercisers (greater than 3h per week)
- Any person who is on a medically prescribed diet
- Any person who is vegan, or any type of vegetarian other than pesco-vegetarian
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 |
|---|---|---|
| PUFA DietThe 7-day diet will consist of 50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids. | Other | PUFA Diet |
| Control DietThe 7-day diet will consist of 50% carbohydrate, 35% fat, and 15% protein. Furthermore, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids. | Other | Control Diet |
Primary outcome
Change in Blood Markers
Time frame: Change measures baseline and 9 days
Change in inflammation and coagulation factors
4 secondary outcomes
Change in Energy Expenditure
Time frame: Change measures baseline and 9 days
Change in Substrate Oxidation
Time frame: Change measures baseline and 9 days
Change in Fasting Blood Lipids
Time frame: Change measures baseline and 9 days
Change in Systolic Blood Pressure
Time frame: Change measures baseline and 9 days
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 8 Oct 2015.
- Derived from this study: PubMed 32153916Kaviani S, Taylor CM, Stevenson JL, Cooper JA, Paton CM. A 7-day high-PUFA diet reduces angiopoietin-like protein 3 and 8 responses and postprandial triglyceride levels in healthy females but not males: a randomized control trial. BMC Nutr. 2019 Jan 6;5:1. doi: 10.1186/s40795-018-0262-7. eCollection 2019.
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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.
jamie A Cooper, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PUFA Diet in people with Inflammation and Obesity, run by University of Georgia 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?
The sponsor lists 1 inclusion and 13 exclusion criteria. 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 8 Oct 2015. 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. Some participants in this study may receive a placebo. 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?
Change in Blood Markers (time frame: Change measures baseline and 9 days). 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 NCT02246933, which also lists 1 linked publication.
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 8 Oct 2015.