Cardiovascular DiseaseALDNCT01101230
Effects of Almonds on Cardiovascular Risk Factors
A study testing Almonds in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this research is to build the evidence base for approval of FDA health claims related to almonds and cardiovascular disease. A randomized, 2-period, crossover controlled feeding study was designed to compare the effects of two blood cholesterol lowering diets that meet the American Heart Association… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Almonds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2012
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI (20-35)
- Low density lipoprotein cholesterol males (128-194mg/dL) and females (121-190 mg/dL)
Who cannot join
- Pregnant, planning to become pregnant, or lactating
- Smoking; cholesterol-lowering medication
- Glucose-lowering medication
- Over the counter cholesterol-lowering substances (e.g.: psyllium, fish oil, soy lecithin, phytoestrogen)
- The following medical conditions:
- heart disease
Show all 19Show fewer
- stroke
- Heart attack
- blood pressure >140/90
- diabetes
- renal or kidney disease
- rheumatoid arthritis
- blood clotting disorder
- liver disease or cirrhosis
- compromised immune system
- peripheral vascular disease or circulation problems
- > 10% body weight loss in the past 6 months
- vegetarian
- nut allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Effects of a Diet Rich in Almonds on LDL Cholesterol, LDL Particle Size, Abdominal Adiposity and Vascular Health
The purpose of this research is to build the evidence base for approval of FDA health claims related to almonds and cardiovascular disease. A randomized, 2-period, crossover controlled feeding study was designed to compare the effects of two blood cholesterol lowering diets that meet the American Heart Association recommendations. The nutrient profiles of the control diet (no almonds/day) and almond diet (1.5 oz. of almonds/day) are matched for protein, saturated fat, and cholesterol. The study population consists of two cohorts of 25 men and women with moderately elevated LDL-C. The investigators hypothesize that a cholesterol-lowering diet designed with almonds confers greater cardioprotective effects than a cholesterol-lowering diet without almonds on the basis of the LDL-C lowering response, effect on LDL particle size, abdominal adiposity and vascular health.
- Conditions
- Cardiovascular Disease
- Being tested
- Almonds
- Keywords
- Cardiovascular disease, cholesterol, low-density, lipoprotein, high-density lipoprotein, triglycerides
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsOther
1.5 oz almonds/day
| Study group | Role | What they receive |
|---|---|---|
| Almond | Experimental | Not described Receives: Other: Almonds |
| Muffin | Placebo comparator | Not described Receives: Other: Almonds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid/lipoprotein profile
Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides are measured as part of the lipoprotein profile.
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
Secondary outcomes (10)
Additional lipid/lipoprotein measures (VLDL, IDL, and remnant lipoproteins)
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
Lipoprotein (LDL, HDL, VLDL, IDL) subclasses
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
Abdominal adiposity as measured by dual-energy x-ray absorptiometry
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
Leg adiposity as measured by dual-energy x-ray absorptiometry
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
Apolipoproteins (A1 and B)
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
Vascular health (plasma nitric oxide)
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
Total body composition as measured by dual-energy x-ray absorptiometry
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
Waist circumference
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
HDL functionality (cholesterol efflux)
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
Cholesterol absorption/synthesis (measured by plasma plant sterols and cholesterol precursors)
Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
Measured: End of diet period 1 (week 6) and diet period 2 (week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startSep 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, Principal investigator, Penn State UniversityClaire E Berryman, Study director, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101230
- Sponsor's protocol ID
- PKE 104
- Acronym
- ALD
- Status last verified
- Aug 2023
- First submitted
- 24 Mar 2010
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Berryman CE, Fleming JA, Kris-Etherton PM. Inclusion of Almonds in a Cholesterol-Lowering Diet Improves Plasma HDL Subspecies and Cholesterol Efflux to Serum in Normal-Weight Individuals with Elevated LDL Cholesterol. J Nutr. 2017 Aug;147(8):1517-1523. doi: 10.3945/jn.116.245126. Epub 2017 Jun 14.
PubMed 28615375Berryman CE, West SG, Fleming JA, Bordi PL, Kris-Etherton PM. Effects of daily almond consumption on cardiometabolic risk and abdominal adiposity in healthy adults with elevated LDL-cholesterol: a randomized controlled trial. J Am Heart Assoc. 2015 Jan 5;4(1):e000993. doi: 10.1161/JAHA.114.000993.
PubMed 25559009
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Diet Rich in Almonds on LDL Cholesterol, LDL Particle Size, Abdominal Adiposity and Vascular Health
- ClinicalTrials.gov ID
- NCT01101230
- Acronym / sponsor ID
- ALD / PKE 104
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, cholesterol, low-density, lipoprotein, high-density lipoprotein, triglycerides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- Sep 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 9 Apr 2010 (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 purpose of this research is to build the evidence base for approval of FDA health claims related to almonds and cardiovascular disease. A randomized, 2-period, crossover controlled feeding study was designed to compare the effects of two blood cholesterol lowering diets that meet the American Heart Association recommendations. The nutrient profiles of the control diet (no almonds/day) and almond diet (1.5 oz. of almonds/day) are matched for protein, saturated fat, and cholesterol. The study population consists of two cohorts of 25 men and women with moderately elevated LDL-C. The investigators hypothesize that a cholesterol-lowering diet designed with almonds confers greater cardioprotective effects than a cholesterol-lowering diet without almonds on the basis of the LDL-C lowering response, effect on LDL particle size, abdominal adiposity and vascular health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond | Experimental | Other: Almonds |
| Muffin | Placebo comparator | Other: Almonds |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI (20-35)
- Low density lipoprotein cholesterol males (128-194mg/dL) and females (121-190 mg/dL)
Key exclusion criteria (19 listed)
- Pregnant, planning to become pregnant, or lactating
- Smoking; cholesterol-lowering medication
- Glucose-lowering medication
- Over the counter cholesterol-lowering substances (e.g.: psyllium, fish oil, soy lecithin, phytoestrogen)
- The following medical conditions:
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 |
|---|---|---|
| Almonds1.5 oz almonds/day | Other | Almond, Muffin |
Primary outcome
Lipid/lipoprotein profile
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides are measured as part of the lipoprotein profile. Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
10 secondary outcomes
Additional lipid/lipoprotein measures (VLDL, IDL, and remnant lipoproteins)
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Lipoprotein (LDL, HDL, VLDL, IDL) subclasses
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Abdominal adiposity as measured by dual-energy x-ray absorptiometry
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Leg adiposity as measured by dual-energy x-ray absorptiometry
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Apolipoproteins (A1 and B)
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Vascular health (plasma nitric oxide)
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Total body composition as measured by dual-energy x-ray absorptiometry
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Waist circumference
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
HDL functionality (cholesterol efflux)
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
Cholesterol absorption/synthesis (measured by plasma plant sterols and cholesterol precursors)
Time frame: End of diet period 1 (week 6) and diet period 2 (week 14)
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 21 Aug 2023.
- Derived from this study: PubMed 28615375Berryman CE, Fleming JA, Kris-Etherton PM. Inclusion of Almonds in a Cholesterol-Lowering Diet Improves Plasma HDL Subspecies and Cholesterol Efflux to Serum in Normal-Weight Individuals with Elevated LDL Cholesterol. J Nutr. 2017 Aug;147(8):1517-1523. doi: 10.3945/jn.116.245126. Epub 2017 Jun 14.
- Derived from this study: PubMed 25559009Berryman CE, West SG, Fleming JA, Bordi PL, Kris-Etherton PM. Effects of daily almond consumption on cardiometabolic risk and abdominal adiposity in healthy adults with elevated LDL-cholesterol: a randomized controlled trial. J Am Heart Assoc. 2015 Jan 5;4(1):e000993. doi: 10.1161/JAHA.114.000993.
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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.
Penny M Kris-Etherton principal investigator
Penn State University
Claire E Berryman study director
Penn State 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 Almonds in people with Cardiovascular Disease, run by Penn State 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 2 inclusion and 19 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 21 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Lipid/lipoprotein profile (time frame: End of diet period 1 (week 6) and diet period 2 (week 14)). 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 NCT01101230, which also lists 2 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 21 Aug 2023.