Metabolic SyndromeFEMMES IINCT01093560
Fat Effects in Women With Metabolic Syndrome
A study testing fat feeding in people with Metabolic Syndrome, run by University of Washington at 1 site in United States.
Trial summary
Among 10 premenopausal women with Metabolic Syndrome: Specific Aim 1: Compare the effects of acute fat feeding on flow mediated dilation (FMD) as measured by brachial artery reactivity among three fat challenges (saturated fat vs. monounsaturated fat (MUFA) vs. polyunsaturated fat (PUFA)at 4 hours post feeding. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- fat feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2011
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female,
- 18-50 years of age,
- Pre-menopausal,
- Weight stable for at least 3 months,
- Not planning to lose or gain weight for 3 months,
- Meets the following 3/5 criteria for metabolic syndrome:
Show all 11Show fewer
- increased blood sugar
- increased blood fats (triglycerides),
- increased blood pressure,
- decreased good cholesterol (HDL-C).
- increased waist circumference,
Who cannot join
- History of diabetes mellitus
- Fasting glucose ≥ 126 mg/dL
- History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)
- Pregnant or planning a pregnancy within the study period
- Fasting triglycerides > 500 mg/dL
- Currently taking lipid lowering medications**
Show all 20Show fewer
- Oral or patch hormone contraception**
- Currently taking vaso-active (blood pressure) medications**
- SBP ≥ 140 and/or DBP ≥90 mm Hg or taking blood pressure lowering Rx
- Chronic use of aspirin (prn use is allowed)
- Chronic use of non-steroidal anti-inflammatory medications (prn use is allowed)
- Tobacco use within 6 months of starting study
- Participation in another clinical trial within the last 30 days
- History of active gall bladder disease
- History of digestive or malabsorptive disease requiring treatment or surgery
- Moderate to severe lactose intolerance
- Milk Allergy
- Walnut Allergy or Nut Allergy
- Coconut allergy
- () Drugs within the following classifications are exclusionary: Lipid lowering, beta blockers, ACE inhibitors, angiotensin receptor blockers, diuretics, calcium channel blockers, alpha blockers, nitrates, hormone contraception includes patch or oral hormone contraception (Hormone containing IUDs or vaginal rings are okay)
Trial locations and contacts
1 site in 1 country.
About this study
Among 10 premenopausal women with Metabolic Syndrome:
Specific Aim 1: Compare the effects of acute fat feeding on flow mediated dilation (FMD) as measured by brachial artery reactivity among three fat challenges (saturated fat vs. monounsaturated fat (MUFA) vs. polyunsaturated fat (PUFA)at 4 hours post feeding. Hypothesis Saturated fat feeding will impair FMD but MUFA and PUFA feeding will not.
Specific Aim 2: Compare the effects of acute feeding on vascular inflammation as measured by VCAM and sICAM among three fat challenges at 3 1/2 hours post feeding.
Hypothesis: Saturated fat feeding will increase vascular inflammation but MUFA and PUFA will not.
- Conditions
- Metabolic Syndrome
- Being tested
- fat feeding
- Keywords
- metabolic syndrome, premenopausal women, fat feeding
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fat feedingDietary supplement
Each feeding will consist of 473 mL of nonfat milk and 50 gms oil. The oil will be high in saturated fat, monounsaturated fat or polyunsaturated fat.
| Study group | Role | What they receive |
|---|---|---|
| young women with MetS | Experimental | 1. Saturated fat (control)
2. n-3 Polyunsaturated fat (experimental)
3. monounsaturated fat Receives: Dietary Supplement: fat feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilation at 4 hours post feeding
4 hours
Measured: four hours
Secondary outcomes (1)
Adhesion molecules (VCAM and sICAM)
Measured: 3 1/2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Pathmaja Paramsothy, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093560
- Sponsor's protocol ID
- 36899-D
- Acronym
- FEMMES II
- Status last verified
- Aug 2011
- First submitted
- 18 Mar 2010
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Effects in Women With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01093560
- Acronym / sponsor ID
- FEMMES II / 36899-D
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, premenopausal women, fat feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 26 Mar 2010 (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.
Among 10 premenopausal women with Metabolic Syndrome:
Specific Aim 1: Compare the effects of acute fat feeding on flow mediated dilation (FMD) as measured by brachial artery reactivity among three fat challenges (saturated fat vs. monounsaturated fat (MUFA) vs. polyunsaturated fat (PUFA)at 4 hours post feeding. Hypothesis Saturated fat feeding will impair FMD but MUFA and PUFA feeding will not.
Specific Aim 2: Compare the effects of acute feeding on vascular inflammation as measured by VCAM and sICAM among three fat challenges at 3 1/2 hours post feeding.
Hypothesis: Saturated fat feeding will increase vascular inflammation but MUFA and PUFA will not.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| young women with MetS | Experimental | Dietary Supplement: fat feeding1. Saturated fat (control) 2. n-3 Polyunsaturated fat (experimental) 3. monounsaturated fat |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female,
- 18-50 years of age,
- Pre-menopausal,
- Weight stable for at least 3 months,
- Not planning to lose or gain weight for 3 months,
Key exclusion criteria (20 listed)
- History of diabetes mellitus
- Fasting glucose ≥ 126 mg/dL
- History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)
- Pregnant or planning a pregnancy within the study period
- Fasting triglycerides > 500 mg/dL
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 |
|---|---|---|
| fat feedingEach feeding will consist of 473 mL of nonfat milk and 50 gms oil. The oil will be high in saturated fat, monounsaturated fat or polyunsaturated fat. | Dietary supplement | young women with MetS |
Primary outcome
Flow Mediated Dilation at 4 hours post feeding
Time frame: four hours
4 hours
1 secondary outcome
Adhesion molecules (VCAM and sICAM)
Time frame: 3 1/2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Pathmaja Paramsothy, MD, MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fat feeding in people with Metabolic Syndrome, run by University of Washington 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 11 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 5 Aug 2011. 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?
Results are not available in the source record.
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?
Flow Mediated Dilation at 4 hours post feeding (time frame: four hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2011.