Effect of Dried Fruit on Cardiometabolic Risk Factors

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Cardiovascular Diseases; Metabolic Syndrome

Treatments: Dietary Supplement: Dried Fruit; Other: High Carbohydrate Snack

Study type: Interventional

Funder types: Other

Identifiers

NCT03020758

PKE DRIED FRUIT

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Dried Fruit

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dried Fruit

Control

Experimental group

Description:

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

Treatment:

Other: High Carbohydrate Snack