Cardiovascular DiseasesNCT00005336
Dietary Treatment of Hyperlipidemia in Women vs. Men
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Washington.
Trial summary
To conduct a dietary intervention trial to test the lipid lowering response to the National Cholesterol Education Program (NCEP) Step Two Diet by free-living hyperlipidemic women and men and to compare the response between them. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1991to Sep 1996
- Phase
- Observational
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To conduct a dietary intervention trial to test the lipid lowering response to the National Cholesterol Education Program (NCEP) Step Two Diet by free-living hyperlipidemic women and men and to compare the response between them.
Read the detailed description
BACKGROUND:
Women experience as much illness from hardening of the arteries including stroke and heart disease as do men, but because women experience them later in life, the importance of heart disease, cholesterol, and diet for women has been under appreciated.
DESIGN NARRATIVE:
Half of the subjects were randomized to diet instruction with two years of follow-up and half to six months of no intervention followed by the same diet instruction and followup. Control subjects had a fasting blood drawn at three months of the nonintervention period. Having parallel intervention and control groups was necessary to test the efficacy of the NCEP Step Two Diet: The diet was taught to study subjects during eight weekly two hour classes. Follow-up included four individual visits, at three, six, nine, and twelve months, with a dietitian and two group sessions, at 4.5 and 10.5 months, in the first year and two individual visits, at 18 and 24 months, in the second year. Fasting blood samples for lipoprotein lipid analysis and 4-day food diaries were collected at all individual visits. Additionally, medical history, lifestyle characteristics, vital signs, other adherence measures, behavioral factors related to adherence, and serum nutrients for monitoring nutrient sufficiency were collected. Dietitians provided adherence and dietary modification counseling as necessary to help participants maximize their adherence. The primary questions to be answered were: 1) Did the NCEP Step Two Diet effectively lower plasma lipids in hypercholesterolemic (HC) and combined hyperlipidemic (CHL) women and men over six months? 2) Did HC and CHL women have a different response than HC and CHL men? 3) Was response in women influenced by menstrual status and sex hormone exposure?, and 4) Were the behavioral adaptations to dietary modification different between women and men?
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startApr 1991
- Study completionSep 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005336
- Sponsor's protocol ID
- 4195
- Other IDs
- R01HL044878
- Status last verified
- Apr 2000
- First submitted
- 25 May 2000
- Last updated
- 10 Feb 2016
- Results posted
- No
Publications
Retzlaff BM, Walden CE, McNeney WB, Buck BL, McCann BS, Knopp RH. Nutritional intake of women and men on the NCEP Step I and Step II diets. J Am Coll Nutr. 1997 Feb;16(1):52-61. doi: 10.1080/07315724.1997.10718649.
PubMed 9013434Walden CE, Retzlaff BM, Buck BL, McCann BS, Knopp RH. Lipoprotein lipid response to the National Cholesterol Education Program step II diet by hypercholesterolemic and combined hyperlipidemic women and men. Arterioscler Thromb Vasc Biol. 1997 Feb;17(2):375-82. doi: 10.1161/01.atv.17.2.375.
PubMed 9081694McCann BS, Bovbjerg VE, Curry SJ, Retzlaff BM, Walden CE, Knopp RH. Predicting participation in a dietary intervention to lower cholesterol among individuals with hyperlipidemia. Health Psychol. 1996 Jan;15(1):61-4. doi: 10.1037//0278-6133.15.1.61.
PubMed 8788542Retzlaff BM, Dowdy AA, Walden CE, Bovbjerg VE, Knopp RH. The Northwest Lipid Research Clinic Fat Intake Scale: validation and utility. Am J Public Health. 1997 Feb;87(2):181-5. doi: 10.2105/ajph.87.2.181.
PubMed 9103094
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Treatment of Hyperlipidemia in Women vs. Men
- ClinicalTrials.gov ID
- NCT00005336
- Acronym / sponsor ID
- 4195
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1991
- Study completion
- Sep 1996
- First posted
- 26 May 2000 (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 conduct a dietary intervention trial to test the lipid lowering response to the National Cholesterol Education Program (NCEP) Step Two Diet by free-living hyperlipidemic women and men and to compare the response between them.
Detailed description
BACKGROUND:
Women experience as much illness from hardening of the arteries including stroke and heart disease as do men, but because women experience them later in life, the importance of heart disease, cholesterol, and diet for women has been under appreciated.
DESIGN NARRATIVE:
Half of the subjects were randomized to diet instruction with two years of follow-up and half to six months of no intervention followed by the same diet instruction and followup. Control subjects had a fasting blood drawn at three months of the nonintervention period. Having parallel intervention and control groups was necessary to test the efficacy of the NCEP Step Two Diet: The diet was taught to study subjects during eight weekly two hour classes. Follow-up included four individual visits, at three, six, nine, and twelve months, with a dietitian and two group sessions, at 4.5 and 10.5 months, in the first year and two individual visits, at 18 and 24 months, in the second year. Fasting blood samples for lipoprotein lipid analysis and 4-day food diaries were collected at all individual visits. Additionally, medical history, lifestyle characteristics, vital signs, other adherence measures, behavioral factors related to adherence, and serum nutrients for monitoring nutrient sufficiency were collected. Dietitians provided adherence and dietary modification counseling as necessary to help participants maximize their adherence. The primary questions to be answered were: 1) Did the NCEP Step Two Diet effectively lower plasma lipids in hypercholesterolemic (HC) and combined hyperlipidemic (CHL) women and men over six months? 2) Did HC and CHL women have a different response than HC and CHL men? 3) Was response in women influenced by menstrual status and sex hormone exposure?, and 4) Were the behavioral adaptations to dietary modification different between women and men?
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 Feb 2016.
- Background: PubMed 9013434Retzlaff BM, Walden CE, McNeney WB, Buck BL, McCann BS, Knopp RH. Nutritional intake of women and men on the NCEP Step I and Step II diets. J Am Coll Nutr. 1997 Feb;16(1):52-61. doi: 10.1080/07315724.1997.10718649.
- Background: PubMed 9081694Walden CE, Retzlaff BM, Buck BL, McCann BS, Knopp RH. Lipoprotein lipid response to the National Cholesterol Education Program step II diet by hypercholesterolemic and combined hyperlipidemic women and men. Arterioscler Thromb Vasc Biol. 1997 Feb;17(2):375-82. doi: 10.1161/01.atv.17.2.375.
- Background: PubMed 8788542McCann BS, Bovbjerg VE, Curry SJ, Retzlaff BM, Walden CE, Knopp RH. Predicting participation in a dietary intervention to lower cholesterol among individuals with hyperlipidemia. Health Psychol. 1996 Jan;15(1):61-4. doi: 10.1037//0278-6133.15.1.61.
- Background: PubMed 9103094Retzlaff BM, Dowdy AA, Walden CE, Bovbjerg VE, Knopp RH. The Northwest Lipid Research Clinic Fat Intake Scale: validation and utility. Am J Public Health. 1997 Feb;87(2):181-5. doi: 10.2105/ajph.87.2.181.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Washington.
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 10 Feb 2016. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005336, which also lists 4 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 Feb 2016.