ObesityPhase 3AFNNCT00696228
High Fat Diet: Oxidative and Cardiovascular Effects
A Phase 3 study testing MUFA, PUFA and SFA in people with Obesity, run by Vanderbilt University at 1 site in United States.
Trial summary
To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- MUFA, PUFA and SFA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2013
- Phase
- Phase 3
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 30-39.9
- Female
- Age 21-40
Who cannot join
- Smoker
- Comorbid Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Fat Diet: Oxidative Effects and Cardiovascular Risk
To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance.
Read the detailed description
To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance.
- Conditions
- Obesity
- Being tested
- Placebo, MUFA, PUFA, SFA
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo
MUFADietary supplement
MUFA
PUFADietary supplement
PUFA
SFADietary supplement
SFA
| Study group | Role | What they receive |
|---|---|---|
| AFN A | Placebo comparator | High Fat Diet Placebo Receives: Dietary Supplement: Placebo |
| AFN B | Experimental | MUFA Receives: Dietary Supplement: MUFA |
| AFN C | Experimental | PUFA Receives: Dietary Supplement: PUFA |
| AFN D | Experimental | SFA Receives: Dietary Supplement: SFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function
Measured: 4 months
Secondary outcomes (1)
energy balance and body composition
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2012
- Study completionDec 2013
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert C. Atkins Foundation
- Responsible party
- Principal investigator, Heidi J. Silver, Vanderbilt University
- Investigators
- Heidi J Silver, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696228
- Sponsor's protocol ID
- 071325
- Acronym
- AFN
- Status last verified
- Nov 2020
- First submitted
- 9 Jun 2008
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Niswender KD, Fazio S, Gower BA, Silver HJ. Balanced high fat diet reduces cardiovascular risk in obese women although changes in adipose tissue, lipoproteins, and insulin resistance differ by race. Metabolism. 2018 May;82:125-134. doi: 10.1016/j.metabol.2018.01.020. Epub 2018 Jan 31.
PubMed 29382504Silver HJ, Kang H, Keil CD, Muldowney JA 3rd, Kocalis H, Fazio S, Vaughan DE, Niswender KD. Consuming a balanced high fat diet for 16 weeks improves body composition, inflammation and vascular function parameters in obese premenopausal women. Metabolism. 2014 Apr;63(4):562-73. doi: 10.1016/j.metabol.2014.01.004. Epub 2014 Jan 17.
PubMed 24559846
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Fat Diet: Oxidative Effects and Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT00696228
- Acronym / sponsor ID
- AFN / 071325
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Robert C. Atkins Foundation
- Study start
- Aug 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Jun 2008 (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.
To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance.
Detailed description
To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AFN A | Placebo comparator | Dietary Supplement: PlaceboHigh Fat Diet Placebo |
| AFN B | Experimental | Dietary Supplement: MUFAMUFA |
| AFN C | Experimental | Dietary Supplement: PUFAPUFA |
| AFN D | Experimental | Dietary Supplement: SFASFA |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 30-39.9
- Female
- Age 21-40
Key exclusion criteria (2 listed)
- Smoker
- Comorbid Disease
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 |
|---|---|---|
| PlaceboPlacebo | Dietary supplement | AFN A |
| MUFAMUFA | Dietary supplement | AFN B |
| PUFAPUFA | Dietary supplement | AFN C |
| SFASFA | Dietary supplement | AFN D |
Primary outcome
endothelial function
Time frame: 4 months
1 secondary outcome
energy balance and body composition
Time frame: 4 months
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 10 Nov 2020.
- Derived from this study: PubMed 29382504Niswender KD, Fazio S, Gower BA, Silver HJ. Balanced high fat diet reduces cardiovascular risk in obese women although changes in adipose tissue, lipoproteins, and insulin resistance differ by race. Metabolism. 2018 May;82:125-134. doi: 10.1016/j.metabol.2018.01.020. Epub 2018 Jan 31.
- Derived from this study: PubMed 24559846Silver HJ, Kang H, Keil CD, Muldowney JA 3rd, Kocalis H, Fazio S, Vaughan DE, Niswender KD. Consuming a balanced high fat diet for 16 weeks improves body composition, inflammation and vascular function parameters in obese premenopausal women. Metabolism. 2014 Apr;63(4):562-73. doi: 10.1016/j.metabol.2014.01.004. Epub 2014 Jan 17.
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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.
Heidi J Silver, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MUFA, PUFA and SFA in people with Obesity, run by Vanderbilt University 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 3 inclusion and 2 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 10 Nov 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
endothelial function (time frame: 4 months). 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 NCT00696228, 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 10 Nov 2020.