Cross-over Pilot Study of Blood Cholesterol Response to Dietary Saturated Fat in Patients With Autosomal Dominant Hypercholesterolemia

Familial Hypercholesterolemia Clinical Trial

Official title:

Randomized, Cross-over Pilot Study of Blood Cholesterol Response to Dietary Saturated Fat in Patients With Autosomal Dominant Hypercholesterolemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03756779
• Other study ID #: 122016-032
• Status: Withdrawn
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adults, age > 18 years or < 80 years

2. 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.

3. Willing to come off medical therapy 4 weeks before and during study.

4. Willing to follow high/low saturated fat diet

5. Willing to attend dietary counseling sessions

6. Willing to attend frequent clinic visits

7. 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:

1. 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.

2. 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.

3. Patients unable to maintain their current activity level or planning to increase their activity level (e.g. new exercise regimen).

4. Pregnant or breast-feeding women.

5. Major illness

6. Secondary cause of dyslipidemia (e.g. obstructive liver disease, hypothyroidism, or nephrotic syndrome)

7. Hospitalization within 3 months

8. 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).

9. Immunodeficiency or HIV-positive status

10. Illiteracy

11. 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)

12. Any other medical condition thought to limit survival to less than 1 year

13. Difficulties or major inconvenience to change dietary habits

14. History of food allergy with hypersensitivity to any of the components of olive oil or nuts

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Other:
• Dietary intervention
Dietary intervention with dietary modification of fat intake.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL-cholesterol	To quantify the change in low density lipoprotein cholesterol	4 weeks