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Effect of Dried Fruit on Cardiometabolic Risk Factors

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ClinicalTrials.gov Identifier: NCT03020758
Recruitment Status : Active, not recruiting
First Posted : January 13, 2017
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
International Nut and Dried Fruit Council
California Dried Plum Board
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Metabolic Syndrome Dietary Supplement: Dried Fruit Other: High Carbohydrate Snack Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. LDL Cholesterol [ Time Frame: 4 weeks ]
    serum low-density cholesterol concentration


Secondary Outcome Measures :
  1. HDL-cholesterol, non-HDL cholesterol, triglycerides [ Time Frame: 4 weeks ]
    serum concentrations of HDL and non-HDL cholesterol and triglycerides

  2. Central blood pressure [ Time Frame: 4 weeks ]
    central systolic and diastolic blood pressure

  3. Pulse wave velocity [ Time Frame: 4 weeks ]
    carotid-femoral pulse wave velocity

  4. Brachial blood pressure [ Time Frame: 4 weeks ]
    brachial systolic and diastolic blood pressure

  5. Plasma glucose [ Time Frame: 4 weeks ]
    fasting plasma glucose

  6. High-sensitivity C-reactive protein [ Time Frame: 4 weeks ]
    serum hs-CRP

  7. Serum insulin [ Time Frame: 4 weeks ]
    fasting serum insulin


Other Outcome Measures:
  1. Fecal Microbiome [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020758


Locations
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United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
International Nut and Dried Fruit Council
California Dried Plum Board
Investigators
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Principal Investigator: Penny Kris-Etherton, PhD Penn State University

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Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT03020758     History of Changes
Other Study ID Numbers: PKE DRIED FRUIT
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cardiovascular Diseases
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases