Cardiovascular Diseases, Metabolic Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDried Fruit
Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.
Calorie-matched carbohydrate-rich snack.
Sponsors
International Nut and Dried Fruit Council
California Dried Plum Board
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL Cholesterol | 4 weeks | serum low-density cholesterol concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Plasma glucose | 4 weeks | fasting plasma glucose |
| High-sensitivity C-reactive protein | 4 weeks | serum hs-CRP |
| Serum insulin | 4 weeks | fasting serum insulin |
| Brachial blood pressure | 4 weeks | brachial systolic and diastolic blood pressure |
Other
| Measure | Time frame |
|---|---|
| Fecal Microbiome | 4 weeks |
Countries
United States
Outcome results
None listed