Cardiovascular DiseaseCASNCT01882881
Effects of Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors
A study testing Dark Chocolate/Cocoa Diet, Almond Diet and Dark Chocolate/Cocoa + Almond Diet in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the individual and combined effects of dark chocolate/cocoa and almonds on lipids, lipoproteins, antioxidant defense, lipid peroxidation, phenolic acids, inflammatory status, blood pressure and arterial health. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Dark Chocolate/Cocoa Diet, Almond Diet and Dark Chocolate/Cocoa + Almond Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Aug 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight and obese (BMI ≥25, ≤40 kg/m2)
- Moderately elevated LDL-C between the 25-95th percentile from NHANES:
- 105-194 mg/dL for males; 98-190 mg/dL for females.
Who cannot join
- Tobacco use
- Systolic blood pressure ≥159 mm Hg
- Diastolic blood pressure ≥ 99 mm Hg
- A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on meds)
- Blood pressure or cholesterol-lowering medication use
- Refusal to discontinue intake of putative cholesterol-lowering supplements (e.g. psyllium, fish oil, soy lecithin, niacin, fiber, flax, stanols/sterols)
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- Vegetarianism or dietary practices that are inconsistent with the test diets
- Nut allergies
- Refusal to discontinue nutritional supplements, herbs, or vitamins
- History of inflammatory gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Clinical Research Center, Noll Lab
University Park, Pennsylvania, 16802
About this study
The purpose of this study is to investigate the individual and combined effects of dark chocolate/cocoa and almonds on lipids, lipoproteins, antioxidant defense, lipid peroxidation, phenolic acids, inflammatory status, blood pressure and arterial health. It is hypothesized that dark chocolate/cocoa and/or almonds will favorably affect lipids, lipoproteins, antioxidants, inflammatory status, blood pressure and arterial health compared to a healthy American control diet; however, the effects will be greater when dark chocolate/cocoa and almonds are consumed together versus consumption of each food individually.
- Conditions
- Cardiovascular Disease
- Being tested
- Healthy American Control Diet, Dark Chocolate/Cocoa Diet, Almond Diet, Dark Chocolate/Cocoa + Almond Diet
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy American Control DietOther
The Control Diet will be comprised of the same foods as the test diets except for the isocaloric substitution of almonds and/or dark chocolate and cocoa for sources of saturated fat; an approximate 250 kcal substitution. In an effort to keep all the diets consistent (except for the specific foods to be tested), the Control Diet will be slightly higher in fiber (20-25g) and lower in cholesterol (~250 mg) than the typical consumption practices (15g and 278 mg, respectively).
Dark Chocolate/Cocoa DietOther
The Dark Chocolate/Cocoa Diet will include a daily hot cocoa beverage containing 11g of natural cocoa powder and 6 pieces of Hershey's Bliss Dark Chocolate (43g of dark chocolate). This amount of dark chocolate and cocoa will allow for the isocaloric substitution with 1.5oz almonds. The total diet will provide ~33% of calories from fat. The SFA (~12%) in the Dark Chocolate/Cocoa Diet will match that of the Control Diet and be slightly higher than the Almond Diet, however the saturated fat will be comprised largely of stearic acid from the dark chocolate; cholesterol will be ≤200 mg/day. The fiber in the Dark Chocolate/Cocoa Diet will be higher than both the Control and Almond Diets due to the fiber content of the dark chocolate (~9g).
Almond DietOther
The Almond Diet will include 1.5 oz of almonds daily and provide ~34% of calories from fat. The Almond Diet will be lower in SFA than the Control and Dark Chocolate/Cocoa Diets, containing ~ 8-9% calories from SFA. In addition, both almond containing diets will be slightly higher in MUFA and PUFA than the Control and Dark Chocolate/Cocoa Diets, as a result of the nutrient profile of the almonds. Cholesterol will be ≤200 mg/day; fiber will be increased compared to the Control Diet due to the inclusion of almonds.
Dark Chocolate/Cocoa + Almond DietOther
This diet is designed to test the additive effects of combining consumption of dark chocolate and cocoa with almonds. The diet will include the same hot cocoa beverage (11g) and dark chocolate pieces (43g) plus 1.5 oz of almonds. Additional high saturated fat foods are removed from the Control Diet to account for both the dark chocolate and almonds. As a result, the total fat will be similar to the other three test diets at ~34-35% and the SFA will match that of the Almond Diet at ~8-9%. The fiber content of this diet will be highest (~35g); cholesterol will remain ≤200 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Healthy American Control Diet | Active comparator | Not described Receives: Other: Healthy American Control Diet |
| Dark Chocolate/Cocoa Diet | Experimental | Not described Receives: Other: Dark Chocolate/Cocoa Diet |
| Almond Diet | Experimental | Not described Receives: Other: Almond Diet |
| Dark Chocolate/Cocoa + Almond Diet | Experimental | Not described Receives: Other: Dark Chocolate/Cocoa + Almond Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid/lipoprotein change (standard panel)
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
24-hour ambulatory blood pressure change
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Flow-mediated dilation change
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Lipoprotein class and subclass change
The VAP© Test provides a direct measure of the following lipid and lipoprotein classes and subclasses: LDL, Lp(a), IDL, LDL1, LDL2, LDL3, LDL4, HDL, HDL2, HDL3, VLDL, VLDL1+2, VLDL3, TC, TG, Non-HDL, Remnant Lipoproteins, ApoB100, and ApoA1.
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Secondary outcomes (7)
Serum C-reactive protein change
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Serum insulin change
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Serum glucose change
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Plasma flavonoid change
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
LDL oxidation potential change (plasma)
The ex vivo resistance of LDL to Cu2+-mediated oxidation will be determined.
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Urinary F2α-isoprostane change
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Plasma tocopherol change
Measured: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2016
- Study completionAug 2016
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.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California, The Hershey Company
- Responsible party
- Sponsor
- Investigators
- Penny M. Kris-Etherton, PhD, RD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882881
- Sponsor's protocol ID
- PKE 107
- Acronym
- CAS
- Status last verified
- Aug 2023
- First submitted
- 12 Apr 2013
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee Y, Berryman CE, West SG, Chen CO, Blumberg JB, Lapsley KG, Preston AG, Fleming JA, Kris-Etherton PM. Effects of Dark Chocolate and Almonds on Cardiovascular Risk Factors in Overweight and Obese Individuals: A Randomized Controlled-Feeding Trial. J Am Heart Assoc. 2017 Nov 29;6(12):e005162. doi: 10.1161/JAHA.116.005162.
PubMed 29187388
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 Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors
- ClinicalTrials.gov ID
- NCT01882881
- Acronym / sponsor ID
- CAS / PKE 107
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Almond Board of California, The Hershey Company
- Study start
- Mar 2012 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Jun 2013 (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 study is to investigate the individual and combined effects of dark chocolate/cocoa and almonds on lipids, lipoproteins, antioxidant defense, lipid peroxidation, phenolic acids, inflammatory status, blood pressure and arterial health. It is hypothesized that dark chocolate/cocoa and/or almonds will favorably affect lipids, lipoproteins, antioxidants, inflammatory status, blood pressure and arterial health compared to a healthy American control diet; however, the effects will be greater when dark chocolate/cocoa and almonds are consumed together versus consumption of each food individually.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy American Control Diet | Active comparator | Other: Healthy American Control Diet |
| Dark Chocolate/Cocoa Diet | Experimental | Other: Dark Chocolate/Cocoa Diet |
| Almond Diet | Experimental | Other: Almond Diet |
| Dark Chocolate/Cocoa + Almond Diet | Experimental | Other: Dark Chocolate/Cocoa + Almond Diet |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight and obese (BMI ≥25, ≤40 kg/m2)
- Moderately elevated LDL-C between the 25-95th percentile from NHANES:
- 105-194 mg/dL for males; 98-190 mg/dL for females.
Key exclusion criteria (10 listed)
- Tobacco use
- Systolic blood pressure ≥159 mm Hg
- Diastolic blood pressure ≥ 99 mm Hg
- A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on meds)
- Blood pressure or cholesterol-lowering medication use
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 |
|---|---|---|
| Healthy American Control DietThe Control Diet will be comprised of the same foods as the test diets except for the isocaloric substitution of almonds and/or dark chocolate and cocoa for sources of saturated fat; an approximate 250 kcal substitution. In an effort to keep all the diets consistent (except for the specific foods to be tested), the Control Diet will be slightly higher in fiber (20-25g) and lower in cholesterol (~250 mg) than the typical consumption practices (15g and 278 mg, respectively). | Other | Healthy American Control Diet |
| Dark Chocolate/Cocoa DietThe Dark Chocolate/Cocoa Diet will include a daily hot cocoa beverage containing 11g of natural cocoa powder and 6 pieces of Hershey's Bliss Dark Chocolate (43g of dark chocolate). This amount of dark chocolate and cocoa will allow for the isocaloric substitution with 1.5oz almonds. The total diet will provide ~33% of calories from fat. The SFA (~12%) in the Dark Chocolate/Cocoa Diet will match that of the Control Diet and be slightly higher than the Almond Diet, however the saturated fat will be comprised largely of stearic acid from the dark chocolate; cholesterol will be ≤200 mg/day. The fiber in the Dark Chocolate/Cocoa Diet will be higher than both the Control and Almond Diets due to the fiber content of the dark chocolate (~9g). | Other | Dark Chocolate/Cocoa Diet |
| Almond DietThe Almond Diet will include 1.5 oz of almonds daily and provide ~34% of calories from fat. The Almond Diet will be lower in SFA than the Control and Dark Chocolate/Cocoa Diets, containing ~ 8-9% calories from SFA. In addition, both almond containing diets will be slightly higher in MUFA and PUFA than the Control and Dark Chocolate/Cocoa Diets, as a result of the nutrient profile of the almonds. Cholesterol will be ≤200 mg/day; fiber will be increased compared to the Control Diet due to the inclusion of almonds. | Other | Almond Diet |
| Dark Chocolate/Cocoa + Almond DietThis diet is designed to test the additive effects of combining consumption of dark chocolate and cocoa with almonds. The diet will include the same hot cocoa beverage (11g) and dark chocolate pieces (43g) plus 1.5 oz of almonds. Additional high saturated fat foods are removed from the Control Diet to account for both the dark chocolate and almonds. As a result, the total fat will be similar to the other three test diets at ~34-35% and the SFA will match that of the Almond Diet at ~8-9%. The fiber content of this diet will be highest (~35g); cholesterol will remain ≤200 mg/day. | Other | Dark Chocolate/Cocoa + Almond Diet |
Primary outcome
Lipid/lipoprotein change (standard panel)
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
24-hour ambulatory blood pressure change
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Flow-mediated dilation change
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Lipoprotein class and subclass change
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
The VAP© Test provides a direct measure of the following lipid and lipoprotein classes and subclasses: LDL, Lp(a), IDL, LDL1, LDL2, LDL3, LDL4, HDL, HDL2, HDL3, VLDL, VLDL1+2, VLDL3, TC, TG, Non-HDL, Remnant Lipoproteins, ApoB100, and ApoA1.
7 secondary outcomes
Serum C-reactive protein change
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Serum insulin change
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Serum glucose change
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Plasma flavonoid change
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
LDL oxidation potential change (plasma)
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Urinary F2α-isoprostane change
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Plasma tocopherol change
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
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 29187388Lee Y, Berryman CE, West SG, Chen CO, Blumberg JB, Lapsley KG, Preston AG, Fleming JA, Kris-Etherton PM. Effects of Dark Chocolate and Almonds on Cardiovascular Risk Factors in Overweight and Obese Individuals: A Randomized Controlled-Feeding Trial. J Am Heart Assoc. 2017 Nov 29;6(12):e005162. doi: 10.1161/JAHA.116.005162.
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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, PhD, RD principal investigator
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 Dark Chocolate/Cocoa Diet, Almond Diet and Dark Chocolate/Cocoa + Almond Diet 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 3 inclusion and 10 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. 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 change (standard panel) (time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)). The study lists 4 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 NCT01882881, 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 21 Aug 2023.