Effect of Dried Fruit on Cardiometabolic Risk Factors

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020758
• Other study ID #: PKE DRIED FRUIT
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Syndrome

Intervention

Dietary Supplement:
• Dried Fruit
Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.

Other:
• High Carbohydrate Snack
Calorie-matched carbohydrate-rich snack.

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Penn State University	California Dried Plum Board, International Nut and Dried Fruit Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fecal Microbiome		4 weeks
Primary	LDL Cholesterol	serum low-density cholesterol concentration	4 weeks
Secondary	HDL-cholesterol, non-HDL cholesterol, triglycerides	serum concentrations of HDL and non-HDL cholesterol and triglycerides	4 weeks
Secondary	Central blood pressure	central systolic and diastolic blood pressure	4 weeks
Secondary	Pulse wave velocity	carotid-femoral pulse wave velocity	4 weeks
Secondary	Brachial blood pressure	brachial systolic and diastolic blood pressure	4 weeks
Secondary	Plasma glucose	fasting plasma glucose	4 weeks
Secondary	High-sensitivity C-reactive protein	serum hs-CRP	4 weeks
Secondary	Serum insulin	fasting serum insulin	4 weeks