Effect of Dried Fruit on Cardiometabolic Risk Factors

The Effect of Bioactives in Dried Plums, Figs, Dates, and Raisins Compared With a High Carbohydrate Snack on Risk Factors for Cardiometabolic Disease

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Dried Fruit; Other: High Carbohydrate Snack

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Penn State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dried Fruit; Daily consumption of ¾ cup blend of dried plums, figs, dates and raisins (DPFDR) for 4 weeks	Dietary supplement: Dried Fruit; Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.
Experimental: Control; Daily consumption of isocaloric and macronutrient matched snack food for 4 weeks	Other: High Carbohydrate Snack; Calorie-matched carbohydrate-rich snack.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL Cholesterol	serum low-density cholesterol concentration	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HDL-cholesterol, non-HDL cholesterol, triglycerides	serum concentrations of HDL and non-HDL cholesterol and triglycerides	4 weeks
Central blood pressure	central systolic and diastolic blood pressure	4 weeks
Pulse wave velocity	carotid-femoral pulse wave velocity	4 weeks
Brachial blood pressure	brachial systolic and diastolic blood pressure	4 weeks
Plasma glucose	fasting plasma glucose	4 weeks
High-sensitivity C-reactive protein	serum hs-CRP	4 weeks
Serum insulin	fasting serum insulin	4 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Fecal Microbiome	4 weeks

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: California Dried Plum Board; International Nut and Dried Fruit Council
• Investigators: Principal Investigator: Penny Kris-Etherton, PhD, Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimated): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Metabolic Syndrome
• Other Study ID Numbers: PKE DRIED FRUIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No