Effect of Dried Fruit on Cardiometabolic Risk Factors

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Cardiovascular Diseases
• Interventions: Dietary Supplement: Dried Fruit; Other: High Carbohydrate Snack

• Registration Number: NCT03020758
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Study Start: 2017-02-01
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dried Fruit	Dried Fruit	Daily consumption of ¾ cup blend of dried plums, figs, dates and raisins (DPFDR) for 4 weeks
Control	High Carbohydrate Snack	Daily consumption of isocaloric and macronutrient matched snack food for 4 weeks

Primary Outcome Measures

Name	Time	Method
LDL Cholesterol	4 weeks	serum low-density cholesterol concentration

Secondary Outcome Measures

Name	Time	Method
HDL-cholesterol, non-HDL cholesterol, triglycerides	4 weeks	serum concentrations of HDL and non-HDL cholesterol and triglycerides
Central blood pressure	4 weeks	central systolic and diastolic blood pressure
Pulse wave velocity	4 weeks	carotid-femoral pulse wave velocity
Brachial blood pressure	4 weeks	brachial systolic and diastolic blood pressure
Plasma glucose	4 weeks	fasting plasma glucose
High-sensitivity C-reactive protein	4 weeks	serum hs-CRP
Serum insulin	4 weeks	fasting serum insulin

Trial Locations

Locations (1)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States