NCT03020758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

January 3, 2017

Last Update Submit

August 15, 2023

Conditions

Cardiovascular DiseasesMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • LDL Cholesterol

    serum low-density cholesterol concentration

    4 weeks

Secondary Outcomes (7)

  • HDL-cholesterol, non-HDL cholesterol, triglycerides

    4 weeks

  • Central blood pressure

    4 weeks

  • Pulse wave velocity

    4 weeks

  • Brachial blood pressure

    4 weeks

  • Plasma glucose

    4 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • Fecal Microbiome

    4 weeks

Study Arms (2)

Dried Fruit

EXPERIMENTAL

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

Dietary Supplement: Dried Fruit

Control

EXPERIMENTAL

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

Other: High Carbohydrate Snack

Interventions

Dried FruitDIETARY_SUPPLEMENT

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

Dried Fruit
High Carbohydrate SnackOTHER

Calorie-matched carbohydrate-rich snack.

Control

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesMetabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Penny Kris-Etherton, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 13, 2017

Study Start

February 1, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)