Back to resultsEffect of Dried Fruit on Cardiometabolic Risk Factors
Primary Purpose
Cardiovascular Diseases, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dried Fruit
High Carbohydrate Snack
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility 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
Sites / Locations
- Penn State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dried Fruit
Control
Arm Description
Daily consumption of ¾ cup blend of dried plums, figs, dates and raisins (DPFDR) for 4 weeks
Daily consumption of isocaloric and macronutrient matched snack food for 4 weeks
Outcomes
Primary Outcome Measures
LDL Cholesterol
serum low-density cholesterol concentration
Secondary Outcome Measures
HDL-cholesterol, non-HDL cholesterol, triglycerides
serum concentrations of HDL and non-HDL cholesterol and triglycerides
Central blood pressure
central systolic and diastolic blood pressure
Pulse wave velocity
carotid-femoral pulse wave velocity
Brachial blood pressure
brachial systolic and diastolic blood pressure
Plasma glucose
fasting plasma glucose
High-sensitivity C-reactive protein
serum hs-CRP
Serum insulin
fasting serum insulin
Full Information
NCT ID
NCT03020758
First Posted
January 3, 2017
Last Updated
August 15, 2023
Sponsor
Penn State University
Collaborators
International Nut and Dried Fruit Council, California Dried Plum Board
1. Study Identification
Unique Protocol Identification Number
NCT03020758
Brief Title
Effect of Dried Fruit on Cardiometabolic Risk Factors
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penn State University
Collaborators
International Nut and Dried Fruit Council, California Dried Plum Board
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dried Fruit
Arm Type
Experimental
Arm Description
Daily consumption of ¾ cup blend of dried plums, figs, dates and raisins (DPFDR) for 4 weeks
Arm Title
Control
Arm Type
Experimental
Arm Description
Daily consumption of isocaloric and macronutrient matched snack food for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Dried Fruit
Intervention Description
Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.
Intervention Type
Other
Intervention Name(s)
High Carbohydrate Snack
Intervention Description
Calorie-matched carbohydrate-rich snack.
Primary Outcome Measure Information:
Title
LDL Cholesterol
Description
serum low-density cholesterol concentration
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
HDL-cholesterol, non-HDL cholesterol, triglycerides
Description
serum concentrations of HDL and non-HDL cholesterol and triglycerides
Time Frame
4 weeks
Title
Central blood pressure
Description
central systolic and diastolic blood pressure
Time Frame
4 weeks
Title
Pulse wave velocity
Description
carotid-femoral pulse wave velocity
Time Frame
4 weeks
Title
Brachial blood pressure
Description
brachial systolic and diastolic blood pressure
Time Frame
4 weeks
Title
Plasma glucose
Description
fasting plasma glucose
Time Frame
4 weeks
Title
High-sensitivity C-reactive protein
Description
serum hs-CRP
Time Frame
4 weeks
Title
Serum insulin
Description
fasting serum insulin
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Fecal Microbiome
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penny Kris-Etherton, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Dried Fruit on Cardiometabolic Risk Factors
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