Familial HypercholesterolemiaNCT03756779
Cross-over Pilot Study of Blood Cholesterol Response to Dietary Saturated Fat in Patients With Autosomal Dominant Hypercholesterolemia
A study testing Dietary intervention in people with Familial Hypercholesterolemia, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 30 Jun 2020
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- Dietary intervention
- Keywords
- Diet study
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Dietary intervention with dietary modification of fat intake.
| Study group | Role | What they receive |
|---|---|---|
| Low Saturated Fat Diet | Experimental | Goal will be to attain <7% of daily calories from saturated fat. Replace it with energy from monounsaturated fat. Receives: 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. Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-cholesterol
To quantify the change in low density lipoprotein cholesterol
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start15 May 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Why it stopped: Not enrolling subjects in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756779
- Sponsor's protocol ID
- 122016-032
- Status last verified
- Nov 2018
- First submitted
- 28 Jul 2017
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Cross-over Pilot Study of Blood Cholesterol Response to Dietary Saturated Fat in Patients With Autosomal Dominant Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03756779
- Acronym / sponsor ID
- 122016-032
- Conditions
- Familial Hypercholesterolemia
- Keywords
- Diet study
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enrolling subjects in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 28 Nov 2018 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Saturated Fat Diet | Experimental | Other: Dietary interventionGoal will be to attain <7% of daily calories from saturated fat. Replace it with energy from monounsaturated fat. |
| High Saturated Fat Diet | Active comparator | Other: Dietary interventionGoal will be to attain 15% of daily calories from saturated fat. Decrease intake of monounsaturated fat. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionDietary intervention with dietary modification of fat intake. | Other | High Saturated Fat Diet, Low Saturated Fat Diet |
Primary outcome
Change in LDL-cholesterol
Time frame: 4 weeks
To quantify the change in low density lipoprotein cholesterol
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Familial Hypercholesterolemia, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Change in LDL-cholesterol (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2018.