Status:
WITHDRAWN
Cross-over Pilot Study of Blood Cholesterol Response to Dietary Saturated Fat in Patients With Autosomal Dominant Hypercholesterolemia
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Familial Hypercholesterolemia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03756779
Start Date
May 15 2017
End Date
June 30 2020
Last Update
November 28 2018
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390