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

NCT03756779 | Withdrawn

• 1 other identifier: 122016-032
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Familial Hypercholesterolemia

Keywords

Diet study

Outcome Measures

Primary Outcomes (1)

• Change in LDL-cholesterol

  To quantify the change in low density lipoprotein cholesterol

  4 weeks

Study Arms (2)

Low Saturated Fat Diet

EXPERIMENTAL

Goal will be to attain \<7% of daily calories from saturated fat. Replace it with energy from monounsaturated fat.

Other: Dietary intervention

High Saturated Fat Diet

ACTIVE COMPARATOR

Goal will be to attain 15% of daily calories from saturated fat. Decrease intake of monounsaturated fat.

Other: Dietary intervention

Interventions

Dietary intervention OTHER

Dietary intervention with dietary modification of fat intake.

High Saturated Fat Diet; Low Saturated Fat Diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: November 28, 2018
• Study Start: May 15, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)