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Completed

NCT Number: NCT03020758

Effect of Dried Fruit on Cardiometabolic Risk Factors

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.

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Key information

Conditions

Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dried Fruit

Dietary Supplement

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

High Carbohydrate Snack

Other

Calorie-matched carbohydrate-rich snack.

Primary outcomes

  1. LDL Cholesterol

    Time frame: 4 weeks

    serum low-density cholesterol concentration

Secondary outcomes

  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 outcomes

  1. Fecal Microbiome

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • California Dried Plum Board
  • International Nut and Dried Fruit Council

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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