Effect of Dried Fruit on Cardiometabolic Risk Factors

NCT ID: NCT03020758

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-11-30

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.

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Dried Fruit

Daily consumption of ¾ cup blend of dried plums, figs, dates and raisins (DPFDR) for 4 weeks

Group Type: EXPERIMENTAL

Dried Fruit

Intervention Type: DIETARY_SUPPLEMENT

Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.

Control

Daily consumption of isocaloric and macronutrient matched snack food for 4 weeks

Group Type: EXPERIMENTAL

High Carbohydrate Snack

Intervention Type: OTHER

Calorie-matched carbohydrate-rich snack.

Interventions

Dried Fruit

Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.

Intervention Type: DIETARY_SUPPLEMENT

High Carbohydrate Snack

Calorie-matched carbohydrate-rich snack.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Nut and Dried Fruit Council

UNKNOWN

Sponsor Role: collaborator

California Dried Plum Board

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Penny Kris-Etherton, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Penn State University

University Park, Pennsylvania, United States

Countries

United States

Other Identifiers

PKE DRIED FRUIT

Identifier Type: -

Identifier Source: org_study_id