- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03756779
Cross-over Pilot Study of Blood Cholesterol Response to Dietary Saturated Fat in Patients With Autosomal Dominant Hypercholesterolemia
November 26, 2018 updated by: University of Texas Southwestern Medical Center
Randomized, Cross-over Pilot Study of Blood Cholesterol Response to Dietary Saturated Fat in Patients With Autosomal Dominant Hypercholesterolemia
We are performing a pilot cross-over diet study involving 5 patients with heterozygous FH and 5 patients with unexplained ADH.
The patients will be randomized to a low versus high saturated fat diet for 4 weeks each.
We hypothesize that patients with unexplained ADH may have an exaggerated cholesterol response to saturated fat intake.
The specific aim of this study is to quantify the increase in LDL-C in unexplained ADH patients compared to FH patients.
The pilot study proposed here will develop preliminary data to be used for future funding proposals of larger, randomized studies.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults, age > 18 years or < 80 years
- Pre-treatment LDL-C greater than the 95th percentile for age and sex (corresponding to 190 mg/dL for most adults), with one of the 2 following criteria: (1) tendon xanthoma (proband or first-degree relative) or (2) either first-degree relative with premature CHD (age less than 55 years in men or 65 years in women) or pretreatment LDL-C greater than the 95th percentile for age and sex.
- Willing to come off medical therapy 4 weeks before and during study.
- Willing to follow high/low saturated fat diet
- Willing to attend dietary counseling sessions
- Willing to attend frequent clinic visits
- Subjects willing to participate under the conditions described in the informed consent form (ICF) and able to sign the ICF and applicable HIPAA forms.
Exclusion Criteria:
- Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins. Note: patients on thyroid replacement therapy can be included if the dosage of thyroxine has been stable for 6 weeks prior to the first study visit and thyroid-stimulating hormone (TSH) level is within the normal range.
- Conditions of severe acute vascular stress (e.g. acute coronary syndrome, ischemic stroke, or major vascular surgery) within 3 months prior to the first study visit.
- Patients unable to maintain their current activity level or planning to increase their activity level (e.g. new exercise regimen).
- Pregnant or breast-feeding women.
- Major illness
- Secondary cause of dyslipidemia (e.g. obstructive liver disease, hypothyroidism, or nephrotic syndrome)
- Hospitalization within 3 months
- Substance abuse (illegal drug use, chronic alcoholism or problematic use of alcohol or total daily alcohol intake >2 drinks per day in men and > 1 drink per day in women).
- Immunodeficiency or HIV-positive status
- Illiteracy
- Severe medical condition that may impair the ability of the person to participate in a nutrition intervention study (e.g. digestive disease with fat intolerance, advanced malignancy, or major neurological, psychiatric or endocrine disease)
- Any other medical condition thought to limit survival to less than 1 year
- Difficulties or major inconvenience to change dietary habits
- History of food allergy with hypersensitivity to any of the components of olive oil or nuts
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low Saturated Fat Diet
Goal will be to attain <7% of daily calories from saturated fat.
Replace it with energy from monounsaturated fat.
|
Dietary intervention with dietary modification of fat intake.
|
Active Comparator: High Saturated Fat Diet
Goal will be to attain 15% of daily calories from saturated fat.
Decrease intake of monounsaturated fat.
|
Dietary intervention with dietary modification of fat intake.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in LDL-cholesterol
Time Frame: 4 weeks
|
To quantify the change in low density lipoprotein cholesterol
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2017
Primary Completion (Anticipated)
June 30, 2020
Study Completion (Anticipated)
June 30, 2020
Study Registration Dates
First Submitted
July 28, 2017
First Submitted That Met QC Criteria
November 26, 2018
First Posted (Actual)
November 28, 2018
Study Record Updates
Last Update Posted (Actual)
November 28, 2018
Last Update Submitted That Met QC Criteria
November 26, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 122016-032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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