Cardiovascular DiseaseNCT01404897
Effects of High Fruit, Vegetable, and Dairy Intake on Plasma Lipids and Blood Pressure in Healthy Individuals
A study testing Dietary Intervention in people with Cardiovascular Disease and Dyslipidemia, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial summary
The Dietary Approaches to Stop Hypertension (DASH) trial has been shown to reduce blood pressure and plasma total and LDL-cholesterol (C) compared to a Western diet, but shows no benefit on other blood lipid variables associated with cardiovascular disease (CVD) risk, namely HDL-cholesterol and triglycerides. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Dyslipidemia, Blood Pressure
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2013
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 22 years and older
- Average systolic blood pressure <160 mm Hg and diastolic blood pressure 80 - 95 mm Hg measured on 2 separate days
- Non-smoking
- Agrees to abstain from alcohol and dietary supplements during the study
- Willing to consume all study foods as instructed
Who cannot join
- History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
- Taking hormones or drugs known to affect lipid metabolism or blood pressure.
- Body Mass Index (BMI) > 35
- Total- and LDL-cholesterol > 95th percentile for sex and age.
- Fasting triglycerides > 500 mg/dl.
- Fasting blood sugar (FBS) > 126 mg/dl.
Show all 9Show fewer
- Abnormal thyroid stimulating hormone
- Not weight stable
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Cholesterol Research Center, Children's Hospital Oakland Research Institute
Berkeley, California, 94705
About this study
Official title: Effects of a Modified Lower Carbohydrate, Higher Fat DASH Diet Plan on Plasma Lipids, Lipoprotein Particle Size, and Blood Pressure in Healthy Adults
The Dietary Approaches to Stop Hypertension (DASH) trial has been shown to reduce blood pressure and plasma total and LDL-cholesterol (C) compared to a Western diet, but shows no benefit on other blood lipid variables associated with cardiovascular disease (CVD) risk, namely HDL-cholesterol and triglycerides. The overall objective of this study is to determine whether modification of the DASH diet by substituting carbohydrate with fat will result in improvements in multiple biomarkers of CVD risk. Specifically, the investigators will test the hypotheses that modification of the DASH diet by reducing carbohydrate, primarily in the form of simple sugars and glycemic starches, and allowing for a more liberal intake of total and saturated fat, primarily from dairy foods, will: (1) improve lipoprotein markers of CVD risk (reduced total/HDL-C ratio, apolipoprotein B, small LDL particles, and increased HDL-C, apoAI, and large HDL particles); and (2) result in comparable reductions of systolic and diastolic blood pressure to those achieved with the standard DASH diet. The investigators will also assess the effects of the modified DASH diet on markers of insulin resistance and inflammation. Our main hypotheses will be tested by a controlled dietary intervention conducted in 40 healthy men and women who will be randomly allocated to consume, for 3 weeks each, a control Western diet, a standard DASH diet, and a modified low-carbohydrate DASH diet, separated by 2-week washout periods.
- Conditions
- Cardiovascular Disease, Dyslipidemia, Blood Pressure
- Being tested
- Dietary Intervention
- Keywords
- carbohydrate, DASH diet, blood pressure, cholesterol
- Medical subject headings
- Cardiovascular Diseases, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
3 weeks of a typical Western diet pattern. 48% carbohydrate, 15% protein, 37% fat.
Dietary InterventionOther
3 weeks of a diet based on the Dietary Approaches to Stop Hypertension (DASH) diet plan. 57% carbohydrate, 18% protein, 25% fat.
Dietary InterventionOther
3 weeks of a reduced carbohydrate, higher fat modification of the DASH diet plan. 42% carbohydrate, 18% protein, 40% fat.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention: Control Diet | Experimental | Not described Receives: Other: Dietary Intervention |
| Dietary Intervention: DASH-based diet | Experimental | Not described Receives: Other: Dietary Intervention |
| Dietary Intervention: Modified DASH diet | Experimental | Not described Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total:HDL-cholesterol ratio
Measured: 4 weeks
HDL-cholesterol
Measured: 4 weeks
Apolipoprotein B
Measured: 4 weeks
Apolipoprotein AI
Measured: 4 weeks
Small LDL particles
Measured: 4 weeks
Large HDL particles
Measured: 4 weeks
Total:HDL-cholesterol ratio
Measured: 9 weeks
Total:HDL-cholesterol ratio
Measured: 14 weeks
HDL-cholesterol
Measured: 9 weeks
HDL-cholesterol
Measured: 14 weeks
Apolipoprotein B
Measured: 9 weeks
Apolipoprotein B
Measured: 14 weeks
Apolipoprotein AI
Measured: 9 weeks
Apolipoprotein AI
Measured: 14 weeks
Small LDL particles
Measured: 9 weeks
Small LDL particles
Measured: 14 weeks
Large HDL particles
Measured: 9 weeks
Large HDL particles
Measured: 14 weeks
Secondary outcomes (6)
Blood Pressure
Measured: End of each experimental diet (4 wks, 9 wks, and 14 wks)
Triglycerides
Measured: End of each experimental diet (4 wks, 9 wks, and 14 wks)
Total Cholesterol
Measured: End of each experimental diet (4 wks, 9 wks, and 14 wks)
LDL-Cholesterol
Measured: End of each experimental diet (4 wks, 9 wks, and 14 wks)
Lipoprotein Subclasses (HDL, LDL, IDL, VLDL)
Measured: End of each experimental diet (4 wks, 9 wks, and 14 wks)
HOMA-IR
Measured: End of each experimental diet (4 wks, 9 wks, and 14 wks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Sponsor
- Investigators
- Ronald M Krauss, MD, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404897
- Sponsor's protocol ID
- MM3274
- Status last verified
- Mar 2015
- First submitted
- 22 Jul 2011
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chiu S, Bergeron N, Williams PT, Bray GA, Sutherland B, Krauss RM. Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. Am J Clin Nutr. 2016 Feb;103(2):341-7. doi: 10.3945/ajcn.115.123281. Epub 2015 Dec 30.
PubMed 26718414
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Modified Lower Carbohydrate, Higher Fat DASH Diet Plan on Plasma Lipids, Lipoprotein Particle Size, and Blood Pressure in Healthy Adults
- ClinicalTrials.gov ID
- NCT01404897
- Acronym / sponsor ID
- MM3274
- Conditions
- Cardiovascular Disease, Dyslipidemia, Blood Pressure
- Keywords
- carbohydrate, DASH diet, blood pressure, cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Jul 2011 (estimated)
- 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.
The Dietary Approaches to Stop Hypertension (DASH) trial has been shown to reduce blood pressure and plasma total and LDL-cholesterol (C) compared to a Western diet, but shows no benefit on other blood lipid variables associated with cardiovascular disease (CVD) risk, namely HDL-cholesterol and triglycerides. The overall objective of this study is to determine whether modification of the DASH diet by substituting carbohydrate with fat will result in improvements in multiple biomarkers of CVD risk. Specifically, the investigators will test the hypotheses that modification of the DASH diet by reducing carbohydrate, primarily in the form of simple sugars and glycemic starches, and allowing for a more liberal intake of total and saturated fat, primarily from dairy foods, will: (1) improve lipoprotein markers of CVD risk (reduced total/HDL-C ratio, apolipoprotein B, small LDL particles, and increased HDL-C, apoAI, and large HDL particles); and (2) result in comparable reductions of systolic and diastolic blood pressure to those achieved with the standard DASH diet. The investigators will also assess the effects of the modified DASH diet on markers of insulin resistance and inflammation. Our main hypotheses will be tested by a controlled dietary intervention conducted in 40 healthy men and women who will be randomly allocated to consume, for 3 weeks each, a control Western diet, a standard DASH diet, and a modified low-carbohydrate DASH diet, separated by 2-week washout periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention: Control Diet | Experimental | Other: Dietary Intervention |
| Dietary Intervention: DASH-based diet | Experimental | Other: Dietary Intervention |
| Dietary Intervention: Modified DASH diet | Experimental | Other: Dietary Intervention |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 22 years and older
- Average systolic blood pressure <160 mm Hg and diastolic blood pressure 80 - 95 mm Hg measured on 2 separate days
- Non-smoking
- Agrees to abstain from alcohol and dietary supplements during the study
- Willing to consume all study foods as instructed
Key exclusion criteria (9 listed)
- History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
- Taking hormones or drugs known to affect lipid metabolism or blood pressure.
- Body Mass Index (BMI) > 35
- Total- and LDL-cholesterol > 95th percentile for sex and age.
- Fasting triglycerides > 500 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 Intervention3 weeks of a typical Western diet pattern. 48% carbohydrate, 15% protein, 37% fat. | Other | Dietary Intervention: Control Diet |
| Dietary Intervention3 weeks of a diet based on the Dietary Approaches to Stop Hypertension (DASH) diet plan. 57% carbohydrate, 18% protein, 25% fat. | Other | Dietary Intervention: DASH-based diet |
| Dietary Intervention3 weeks of a reduced carbohydrate, higher fat modification of the DASH diet plan. 42% carbohydrate, 18% protein, 40% fat. | Other | Dietary Intervention: Modified DASH diet |
Primary outcome
Total:HDL-cholesterol ratio
Time frame: 4 weeks
HDL-cholesterol
Time frame: 4 weeks
Apolipoprotein B
Time frame: 4 weeks
Apolipoprotein AI
Time frame: 4 weeks
Small LDL particles
Time frame: 4 weeks
Large HDL particles
Time frame: 4 weeks
Total:HDL-cholesterol ratio
Time frame: 9 weeks
Total:HDL-cholesterol ratio
Time frame: 14 weeks
HDL-cholesterol
Time frame: 9 weeks
HDL-cholesterol
Time frame: 14 weeks
Apolipoprotein B
Time frame: 9 weeks
Apolipoprotein B
Time frame: 14 weeks
Apolipoprotein AI
Time frame: 9 weeks
Apolipoprotein AI
Time frame: 14 weeks
Small LDL particles
Time frame: 9 weeks
Small LDL particles
Time frame: 14 weeks
Large HDL particles
Time frame: 9 weeks
Large HDL particles
Time frame: 14 weeks
6 secondary outcomes
Blood Pressure
Time frame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
Triglycerides
Time frame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
Total Cholesterol
Time frame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
LDL-Cholesterol
Time frame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
Lipoprotein Subclasses (HDL, LDL, IDL, VLDL)
Time frame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
HOMA-IR
Time frame: End of each experimental diet (4 wks, 9 wks, and 14 wks)
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 26 Mar 2015.
- Derived from this study: PubMed 26718414Chiu S, Bergeron N, Williams PT, Bray GA, Sutherland B, Krauss RM. Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. Am J Clin Nutr. 2016 Feb;103(2):341-7. doi: 10.3945/ajcn.115.123281. Epub 2015 Dec 30.
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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.
Ronald M Krauss, MD principal investigator
UCSF Benioff Children's Hospital Oakland
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 Cardiovascular Disease and Dyslipidemia, run by UCSF Benioff Children's Hospital Oakland 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 5 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 26 Mar 2015. 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?
Total:HDL-cholesterol ratio (time frame: 4 weeks). The study lists 18 primary outcomes in all. 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 NCT01404897, which also lists 1 linked publication.
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 26 Mar 2015.