Clinical trial NCT03020758: Effect of Dried Fruit on Cardiometabolic Risk Factors
Official title: The Effect of Bioactives in Dried Plums, Figs, Dates, and Raisins Compared With a High Carbohydrate Snack on Risk Factors for Cardiometabolic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Metabolic Syndrome
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: International Nut and Dried Fruit Council
name: California Dried Plum Board
First posted: 2017-01-13
Enrollment: 55
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a 2-period randomized crossover study with free-living subjects on self-selected diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who are representative of the U.S. population and at risk for cardiovascular disease (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).

The investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood pressure and LDL-cholesterol, and improve artery function (assessed by standard blood pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial stiffness) compared to the control group and baseline.


Eligibility criteria: Inclusion Criteria:

* Body mass index of 25-36 kg/m2

And, at least one of the following:

* LDL-C above 116 mg/dL (3.0 mmol/L)
* Systolic blood pressure 120-159 mmHg
* Diastolic blood pressure 80-99 mmHg
* Increased waist circumference: ≥94 cm for men and ≥80 cm for women
* Elevated glucose (≥ 100 mg/dL and \< 126 mg/dL)
* Triglycerides: above 150 mg/dL (1.69 mmol/L) and below 350 mg/dL (3.95 mmol/L)
* Low HDL-cholesterol: \<40 mg/dL (\< 1.03 mmol/L) for men and \< 50 mg/dL (\<1.29 mmol/L) for women)

Exclusion Criteria:

* Allergies to the test foods
* History of cardiovascular disease, stage II hypertension (BP 160/100 mmHg), kidney disease, diabetes or inflammatory diseases such as gastrointestinal disorders and rheumatoid arthritis
* Use of medication/supplements for elevated lipids, blood pressure, or glucose

Primary outcomes:
measure: LDL Cholesterol
timeFrame: 4 weeks
Secondary outcomes:
measure: HDL-cholesterol, non-HDL cholesterol, triglycerides
timeFrame: 4 weeks
measure: Central blood pressure
timeFrame: 4 weeks
measure: Pulse wave velocity
timeFrame: 4 weeks
measure: Brachial blood pressure
timeFrame: 4 weeks
measure: Plasma glucose
timeFrame: 4 weeks
measure: High-sensitivity C-reactive protein
timeFrame: 4 weeks
measure: Serum insulin
timeFrame: 4 weeks
Other outcomes:
measure: Fecal Microbiome
timeFrame: 4 weeks
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
References: