HypercholesterolemiaPhase 2NCT00349765
Effects of Various Higher Fat and Lower Fat Snacks on Cardiovascular Risk Factors in Men and Women.
A Phase 2 study testing higher fat, high polyunsaturated fat diet, higher fat, high saturated and trans fat diet and lower fat diet in people with Hypercholesterolemia, run by University of Alabama at Birmingham.
Trial summary
The purpose of this study is to determine whether snacks differing in fat amount and type result in changes in cardiovascular disease risk factors in men and women who have mildly elevated cholesterol levels. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- higher fat, high polyunsaturated fat diet, higher fat, high saturated and trans fat diet and lower fat diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Feb 2006
- Phase
- Phase 2
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 19-65
- body mass index 20-35
- weight stable for at least 3 months
- low-density lipoprotein cholesterol 130-180 mg/dL
- triglycerides < 150 mg/dL
- glucose < 126 mg/dL
Who cannot join
- smokers
- type 1 diabetes
- type 2 diabetes
- use of lipid-lowering medications
- hypertension
- pregnancy
- lactation
- planning to become pregnant during the period of the study
About this study
Official title: Cardiovascular Health Effects of Isocaloric Substitution of Polyunsaturated Fat Rich Snacks for Saturated and Trans Fat or Refined Carbohydrate Snacks in Moderately Hypercholesterolemic Individuals.
The purpose of this study is to determine whether snacks differing in fat amount and type result in changes in cardiovascular disease risk factors in men and women who have mildly elevated cholesterol levels. Our hypothesis is that a diet containing snacks rich in polyunsaturated fats lead to a more favorable cardiovascular disease risk profile than a diet containing snacks rich in saturated and trans fats or one containing low-fat snacks.
Read the detailed description
The overall goals of this study are to determine whether snack foods rich in polyunsaturated fats (PUFA) produce beneficial effects on cardiovascular disease risk compared to snacks rich in saturated fats (SFA) and trans fats and snacks rich in refined carbohydrates. The primary objective of this study is to determine the effects of substituting n-6 PUFA (linoleic acid) from snack chips for SFA/trans fat and refined carbohydrate on serum lipids -principally LDL-C - and lipoproteins in moderately hypercholesterolemic men and women. A secondary objective is to assess effects on lipoprotein subclass particle size, intramyocellular lipids, and C-reactive protein (CRP). Forty-two men and women will be recruited to participate in a randomized, crossover, controlled feeding experiment for 3 periods of 4 weeks each. Each feeding phase will be separated by an 8-week washout period. The control diet will be a National Cholesterol Education Program Step 1 diet consisting of approximately 30% energy from total fat, <10% energy from SFA, 5% energy from PUFA, 15% energy from monounsaturated fatty acids (MUFA), 1% energy from trans fat, 55% energy from carbohydrates, and 15% energy from protein. To achieve an isocaloric substitution with PUFA, 300 kcal coming from low-fat, high-carbohydrate snacks will be removed from the Step 1 diet (NCEP diet) and replaced with 300 kcal of PUFA-rich snacks (LO diet). Similarly, 300 kcal from snacks rich in SFA/trans fat will replace the same 300 kcal from the high-carbohydrate from the Step 1 diet for the high SFA diet (SF diet). Subjects will consumed all foods provided by the GCRC and nothing else during each feeding phase. Breakfast and lunch meals will be consumed at the GCRC on weekdays and breakfast on Saturdays. All other meals will be packed and consumed at home. The primary study variable will be serum/plasma LDL-cholesterol. Secondary variables will include lipids and lipoproteins including total cholesterol (TC), HDL-cholesterol, VLDL-cholesterol, and triglycerides, and intramyocellular lipids. Exploratory variables will include assessment of lipid subclass particle size and CRP, a marker of systemic inflammation. Supportive variables will include fasting blood glucose and insulin, percent body fat mass, blood pressure and demographic information. All variables will be measured at baseline and endpoint of each feeding phase.
- Conditions
- Hypercholesterolemia
- Being tested
- higher fat, high polyunsaturated fat diet, higher fat, high saturated and trans fat diet, lower fat diet
- Keywords
- cardiovascular disease, saturated fat, trans fat, polyunsaturated fat, diet, intramyocellular lipid
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
higher fat, high polyunsaturated fat dietBehavioural
higher fat, high saturated and trans fat dietBehavioural
lower fat dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
total cholesterol
low-density lipoprotein cholesterol
high-density lipoprotein cholesterol
triglycerides
Secondary outcomes (8)
C-reactive protein
lipoprotein a
very low-density lipoprotein cholesterol
LDL pattern A or B
blood pressure
body fat
waist circumference
intramyocellular lipid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startMar 2005
- Study completionFeb 2006
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 HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- SmartFoods, Inc.
- Investigators
- Marie-Pierre St-Onge, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349765
- Sponsor's protocol ID
- X041217008
- Status last verified
- Sep 2007
- First submitted
- 30 Jun 2006
- Last updated
- 14 Sep 2007
- Results posted
- No
Publications
St-Onge MP, Aban I, Bosarge A, Gower B, Hecker KD, Allison DB. Snack chips fried in corn oil alleviate cardiovascular disease risk factors when substituted for low-fat or high-fat snacks. Am J Clin Nutr. 2007 Jun;85(6):1503-10. doi: 10.1093/ajcn/85.6.1503.
PubMed 17556685
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Health Effects of Isocaloric Substitution of Polyunsaturated Fat Rich Snacks for Saturated and Trans Fat or Refined Carbohydrate Snacks in Moderately Hypercholesterolemic Individuals.
- ClinicalTrials.gov ID
- NCT00349765
- Acronym / sponsor ID
- X041217008
- Conditions
- Hypercholesterolemia
- Keywords
- cardiovascular disease, saturated fat, trans fat, polyunsaturated fat, diet, intramyocellular lipid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- SmartFoods, Inc.
- Study start
- Mar 2005
- Study completion
- Feb 2006
- First posted
- 10 Jul 2006 (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.
The purpose of this study is to determine whether snacks differing in fat amount and type result in changes in cardiovascular disease risk factors in men and women who have mildly elevated cholesterol levels. Our hypothesis is that a diet containing snacks rich in polyunsaturated fats lead to a more favorable cardiovascular disease risk profile than a diet containing snacks rich in saturated and trans fats or one containing low-fat snacks.
Detailed description
The overall goals of this study are to determine whether snack foods rich in polyunsaturated fats (PUFA) produce beneficial effects on cardiovascular disease risk compared to snacks rich in saturated fats (SFA) and trans fats and snacks rich in refined carbohydrates. The primary objective of this study is to determine the effects of substituting n-6 PUFA (linoleic acid) from snack chips for SFA/trans fat and refined carbohydrate on serum lipids -principally LDL-C - and lipoproteins in moderately hypercholesterolemic men and women. A secondary objective is to assess effects on lipoprotein subclass particle size, intramyocellular lipids, and C-reactive protein (CRP). Forty-two men and women will be recruited to participate in a randomized, crossover, controlled feeding experiment for 3 periods of 4 weeks each. Each feeding phase will be separated by an 8-week washout period. The control diet will be a National Cholesterol Education Program Step 1 diet consisting of approximately 30% energy from total fat, <10% energy from SFA, 5% energy from PUFA, 15% energy from monounsaturated fatty acids (MUFA), 1% energy from trans fat, 55% energy from carbohydrates, and 15% energy from protein. To achieve an isocaloric substitution with PUFA, 300 kcal coming from low-fat, high-carbohydrate snacks will be removed from the Step 1 diet (NCEP diet) and replaced with 300 kcal of PUFA-rich snacks (LO diet). Similarly, 300 kcal from snacks rich in SFA/trans fat will replace the same 300 kcal from the high-carbohydrate from the Step 1 diet for the high SFA diet (SF diet). Subjects will consumed all foods provided by the GCRC and nothing else during each feeding phase. Breakfast and lunch meals will be consumed at the GCRC on weekdays and breakfast on Saturdays. All other meals will be packed and consumed at home. The primary study variable will be serum/plasma LDL-cholesterol. Secondary variables will include lipids and lipoproteins including total cholesterol (TC), HDL-cholesterol, VLDL-cholesterol, and triglycerides, and intramyocellular lipids. Exploratory variables will include assessment of lipid subclass particle size and CRP, a marker of systemic inflammation. Supportive variables will include fasting blood glucose and insulin, percent body fat mass, blood pressure and demographic information. All variables will be measured at baseline and endpoint of each feeding phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 19-65
- body mass index 20-35
- weight stable for at least 3 months
- low-density lipoprotein cholesterol 130-180 mg/dL
- triglycerides < 150 mg/dL
Key exclusion criteria (8 listed)
- smokers
- type 1 diabetes
- type 2 diabetes
- use of lipid-lowering medications
- hypertension
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 |
|---|---|---|
| higher fat, high polyunsaturated fat diet | Behavioural | – |
| higher fat, high saturated and trans fat diet | Behavioural | – |
| lower fat diet | Behavioural | – |
Primary outcome
total cholesterol
low-density lipoprotein cholesterol
high-density lipoprotein cholesterol
triglycerides
8 secondary outcomes
C-reactive protein
lipoprotein a
very low-density lipoprotein cholesterol
LDL pattern A or B
blood pressure
body fat
waist circumference
intramyocellular lipid
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 14 Sep 2007.
- Results publication: PubMed 17556685St-Onge MP, Aban I, Bosarge A, Gower B, Hecker KD, Allison DB. Snack chips fried in corn oil alleviate cardiovascular disease risk factors when substituted for low-fat or high-fat snacks. Am J Clin Nutr. 2007 Jun;85(6):1503-10. doi: 10.1093/ajcn/85.6.1503.
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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.
Marie-Pierre St-Onge, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing higher fat, high polyunsaturated fat diet, higher fat, high saturated and trans fat diet and lower fat diet in people with Hypercholesterolemia, run by University of Alabama at Birmingham.
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 6 inclusion and 8 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 14 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
total cholesterol. The study lists 4 primary outcomes in all. 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 NCT00349765, 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 14 Sep 2007.