HypercholesterolemiaNCT03172611
A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles
A study testing Dietary Intervention in people with Hypercholesterolemia, run by Texas Woman's University at 1 site in United States.
Trial summary
This study evaluates the effects of consuming a defined, plant-based diet on lipoprotein(a) and other atherogenic particles associated with cardiovascular disease risk. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 15 Mar 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index ≥25.0 kg/m^2
- Serum low-density lipoprotein cholesterol concentration ≥100
- Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90
Who cannot join
- Tobacco use
- Drug abuse
- Excessive alcohol consumption (>2 glasses of wine or alcohol equivalent per day for men or >1 glass of wine or alcohol equivalent for woman)
- Current cancer diagnosis
- Estimated glomerular filtration rate <60 mg/dL
- Clinically defined infection
Show all 9Show fewer
- Mental disability
- Hospitalization <6 months
- Previous exposure to plant-based diet
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effects of consuming a defined, plant-based diet on lipoprotein(a) and other atherogenic particles associated with cardiovascular disease risk.
Read the detailed description
Lipoprotein(a) is a carrier of oxidized low-density lipoprotein and is a particularly atherogenic biomarker. Lp(a) has been previously documented to be resistant to dietary therapies and its concentration is thought to be determined by genes. A plant-based diet has not been previously used in an attempt to influence the concentration of Lp(a).
Participants were instructed to follow a defined, plant-based dietary intervention for four weeks. All animal products were excluded. Cooked foods, free oils, soda, alcohol, and coffee were also to be excluded. All meals and snacks were provided to the participants for the full duration of the intervention. Emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. Participants were not advised to alter their exercise habits.
Serum biomarkers were obtained from participants at baseline and after 4-weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- Dietary Intervention
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
Subjects consumed a defined, plant-based diet for 4-weeks. Emphasized were raw fruits and vegetables.
| Study group | Role | What they receive |
|---|---|---|
| Plant-based diet | Experimental | A defined, plant-based diet was prescribed for 4 weeks. Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum lipoprotein(a)
Serum Lp(a) (nmol/L) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Secondary outcomes (8)
Change in serum total cholesterol
Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum low-density lipoprotein cholesterol
LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum high-density lipoprotein cholesterol
Serum HDL (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum apolipoprotein-B
Serum Apo-B (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum low-density lipoprotein particles
Serum LDL-P (nmol/L) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum small-dense low-density lipoprotein cholesterol
Serum sdLDL-C (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum high-density lipoprotein 2 cholesterol
Serum HDL2-C (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Change in serum apolipoprotein A-1
Serum Apo A-1 (mg/dL) was documented at baseline and after 4-weeks
Measured: Baseline and 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start3 Jan 2017
- Primary completion8 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- Montgomery Heart & Wellness
- Responsible party
- Principal investigator, Rami Najjar, Texas Woman's University
- Investigators
- Rami Najjar, M.S., Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172611
- Sponsor's protocol ID
- 192790
- Status last verified
- May 2017
- First submitted
- 29 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown SA, Morrisett J, Patsch JR, Reeves R, Gotto AM Jr, Patsch W. Influence of short term dietary cholesterol and fat on human plasma Lp[a] and LDL levels. J Lipid Res. 1991 Aug;32(8):1281-9.
PubMed 1837559Bloomer RJ, Kabir MM, Canale RE, Trepanowski JF, Marshall KE, Farney TM, Hammond KG. Effect of a 21 day Daniel Fast on metabolic and cardiovascular disease risk factors in men and women. Lipids Health Dis. 2010 Sep 3;9:94. doi: 10.1186/1476-511X-9-94.
PubMed 20815907Jenkins DJ, Kendall CW, Popovich DG, Vidgen E, Mehling CC, Vuksan V, Ransom TP, Rao AV, Rosenberg-Zand R, Tariq N, Corey P, Jones PJ, Raeini M, Story JA, Furumoto EJ, Illingworth DR, Pappu AS, Connelly PW. Effect of a very-high-fiber vegetable, fruit, and nut diet on serum lipids and colonic function. Metabolism. 2001 Apr;50(4):494-503. doi: 10.1053/meta.2001.21037.
PubMed 11288049Le LT, Sabate J. Beyond meatless, the health effects of vegan diets: findings from the Adventist cohorts. Nutrients. 2014 May 27;6(6):2131-47. doi: 10.3390/nu6062131.
PubMed 24871675Jenkins DJ, Kendall CW, Marchie A, Parker TL, Connelly PW, Qian W, Haight JS, Faulkner D, Vidgen E, Lapsley KG, Spiller GA. Dose response of almonds on coronary heart disease risk factors: blood lipids, oxidized low-density lipoproteins, lipoprotein(a), homocysteine, and pulmonary nitric oxide: a randomized, controlled, crossover trial. Circulation. 2002 Sep 10;106(11):1327-32. doi: 10.1161/01.cir.0000028421.91733.20.
PubMed 12221048Kiortsis DN, Tzotzas T, Giral P, Bruckert E, Beucler I, Valsamides S, Turpin G. Changes in lipoprotein(a) levels and hormonal correlations during a weight reduction program. Nutr Metab Cardiovasc Dis. 2001 Jun;11(3):153-7.
PubMed 11590990
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles
- ClinicalTrials.gov ID
- NCT03172611
- Acronym / sponsor ID
- 192790
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- Montgomery Heart & Wellness
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 1 Jun 2017 (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.
This study evaluates the effects of consuming a defined, plant-based diet on lipoprotein(a) and other atherogenic particles associated with cardiovascular disease risk.
Detailed description
Lipoprotein(a) is a carrier of oxidized low-density lipoprotein and is a particularly atherogenic biomarker. Lp(a) has been previously documented to be resistant to dietary therapies and its concentration is thought to be determined by genes. A plant-based diet has not been previously used in an attempt to influence the concentration of Lp(a).
Participants were instructed to follow a defined, plant-based dietary intervention for four weeks. All animal products were excluded. Cooked foods, free oils, soda, alcohol, and coffee were also to be excluded. All meals and snacks were provided to the participants for the full duration of the intervention. Emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. Participants were not advised to alter their exercise habits.
Serum biomarkers were obtained from participants at baseline and after 4-weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plant-based diet | Experimental | Other: Dietary InterventionA defined, plant-based diet was prescribed for 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index ≥25.0 kg/m^2
- Serum low-density lipoprotein cholesterol concentration ≥100
- Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90
Key exclusion criteria (9 listed)
- Tobacco use
- Drug abuse
- Excessive alcohol consumption (>2 glasses of wine or alcohol equivalent per day for men or >1 glass of wine or alcohol equivalent for woman)
- Current cancer diagnosis
- Estimated glomerular filtration rate <60 mg/dL
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 InterventionSubjects consumed a defined, plant-based diet for 4-weeks. Emphasized were raw fruits and vegetables. | Other | Plant-based diet |
Primary outcome
Change in serum lipoprotein(a)
Time frame: Baseline and 4-weeks
Serum Lp(a) (nmol/L) was documented at baseline and after 4-weeks
8 secondary outcomes
Change in serum total cholesterol
Time frame: Baseline and 4-weeks
Change in serum low-density lipoprotein cholesterol
Time frame: Baseline and 4-weeks
Change in serum high-density lipoprotein cholesterol
Time frame: Baseline and 4-weeks
Change in serum apolipoprotein-B
Time frame: Baseline and 4-weeks
Change in serum low-density lipoprotein particles
Time frame: Baseline and 4-weeks
Change in serum small-dense low-density lipoprotein cholesterol
Time frame: Baseline and 4-weeks
Change in serum high-density lipoprotein 2 cholesterol
Time frame: Baseline and 4-weeks
Change in serum apolipoprotein A-1
Time frame: Baseline and 4-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Background: PubMed 1837559Brown SA, Morrisett J, Patsch JR, Reeves R, Gotto AM Jr, Patsch W. Influence of short term dietary cholesterol and fat on human plasma Lp[a] and LDL levels. J Lipid Res. 1991 Aug;32(8):1281-9.
- Background: PubMed 20815907Bloomer RJ, Kabir MM, Canale RE, Trepanowski JF, Marshall KE, Farney TM, Hammond KG. Effect of a 21 day Daniel Fast on metabolic and cardiovascular disease risk factors in men and women. Lipids Health Dis. 2010 Sep 3;9:94. doi: 10.1186/1476-511X-9-94.
- Background: PubMed 11288049Jenkins DJ, Kendall CW, Popovich DG, Vidgen E, Mehling CC, Vuksan V, Ransom TP, Rao AV, Rosenberg-Zand R, Tariq N, Corey P, Jones PJ, Raeini M, Story JA, Furumoto EJ, Illingworth DR, Pappu AS, Connelly PW. Effect of a very-high-fiber vegetable, fruit, and nut diet on serum lipids and colonic function. Metabolism. 2001 Apr;50(4):494-503. doi: 10.1053/meta.2001.21037.
- Background: PubMed 24871675Le LT, Sabate J. Beyond meatless, the health effects of vegan diets: findings from the Adventist cohorts. Nutrients. 2014 May 27;6(6):2131-47. doi: 10.3390/nu6062131.
- Background: PubMed 12221048Jenkins DJ, Kendall CW, Marchie A, Parker TL, Connelly PW, Qian W, Haight JS, Faulkner D, Vidgen E, Lapsley KG, Spiller GA. Dose response of almonds on coronary heart disease risk factors: blood lipids, oxidized low-density lipoproteins, lipoprotein(a), homocysteine, and pulmonary nitric oxide: a randomized, controlled, crossover trial. Circulation. 2002 Sep 10;106(11):1327-32. doi: 10.1161/01.cir.0000028421.91733.20.
- Background: PubMed 11590990Kiortsis DN, Tzotzas T, Giral P, Bruckert E, Beucler I, Valsamides S, Turpin G. Changes in lipoprotein(a) levels and hormonal correlations during a weight reduction program. Nutr Metab Cardiovasc Dis. 2001 Jun;11(3):153-7.
- 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.
Rami Najjar, M.S. principal investigator
Texas Woman's University
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 Hypercholesterolemia, run by Texas Woman's University 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 1 Jun 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 serum lipoprotein(a) (time frame: Baseline and 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03172611, which also lists 6 linked publications.
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 1 Jun 2017.