Clinical trial NCT01882881: Effects of Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors
Official title: Effects of Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Almond Board of California
name: The Hershey Company
First posted: 2013-06-21
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Lipid/lipoprotein change (standard panel)
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
measure: 24-hour ambulatory blood pressure change
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
measure: Flow-mediated dilation change
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
measure: Lipoprotein class and subclass change
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Secondary outcomes:
measure: Serum C-reactive protein change
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
measure: Serum insulin change
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
measure: Serum glucose change
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
measure: Plasma flavonoid change
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
measure: LDL oxidation potential change (plasma)
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
measure: Urinary F2α-isoprostane change
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
measure: Plasma tocopherol change
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Other outcomes:
measure: PON1 activity change (serum)
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
measure: Ex vivo cholesterol efflux change (serum)
timeFrame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Locations:
city: University Park
country: United States
facility: Penn State Clinical Research Center, Noll Lab
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny M. Kris-Etherton, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.