Cardiovascular DiseasesNCT03020758
Effect of Dried Fruit on Cardiometabolic Risk Factors
A study testing Dried Fruit and High Carbohydrate Snack in people with Cardiovascular Diseases and Metabolic Syndrome, run by Penn State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Metabolic Syndrome
- What is being tested?
- Dried Fruit and High Carbohydrate Snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
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
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.
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome
- Being tested
- Dried Fruit, High Carbohydrate Snack
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried FruitDietary supplement
Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.
High Carbohydrate SnackOther
Calorie-matched carbohydrate-rich snack.
| Study group | Role | What they receive |
|---|---|---|
| Dried Fruit | Experimental | Daily consumption of ¾ cup blend of dried plums, figs, dates and raisins (DPFDR) for 4 weeks Receives: Dietary Supplement: Dried Fruit |
| Control | Experimental | Daily consumption of isocaloric and macronutrient matched snack food for 4 weeks Receives: Other: High Carbohydrate Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL Cholesterol
serum low-density cholesterol concentration
Measured: 4 weeks
Secondary outcomes (7)
HDL-cholesterol, non-HDL cholesterol, triglycerides
serum concentrations of HDL and non-HDL cholesterol and triglycerides
Measured: 4 weeks
Central blood pressure
central systolic and diastolic blood pressure
Measured: 4 weeks
Pulse wave velocity
carotid-femoral pulse wave velocity
Measured: 4 weeks
Brachial blood pressure
brachial systolic and diastolic blood pressure
Measured: 4 weeks
Plasma glucose
fasting plasma glucose
Measured: 4 weeks
High-sensitivity C-reactive protein
serum hs-CRP
Measured: 4 weeks
Serum insulin
fasting serum insulin
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- International Nut and Dried Fruit Council, California Dried Plum Board
- Responsible party
- Sponsor
- Investigators
- Penny Kris-Etherton, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020758
- Sponsor's protocol ID
- PKE DRIED FRUIT
- Status last verified
- Aug 2023
- First submitted
- 3 Jan 2017
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03020758
- Acronym / sponsor ID
- PKE DRIED FRUIT
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- International Nut and Dried Fruit Council, California Dried Plum Board
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dried Fruit | Experimental | Dietary Supplement: Dried FruitDaily consumption of ¾ cup blend of dried plums, figs, dates and raisins (DPFDR) for 4 weeks |
| Control | Experimental | Other: High Carbohydrate SnackDaily consumption of isocaloric and macronutrient matched snack food for 4 weeks |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Body mass index of 25-36 kg/m2
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dried FruitMixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily. | Dietary supplement | Dried Fruit |
| High Carbohydrate SnackCalorie-matched carbohydrate-rich snack. | Other | Control |
Primary outcome
LDL Cholesterol
Time frame: 4 weeks
serum low-density cholesterol concentration
7 secondary outcomes
HDL-cholesterol, non-HDL cholesterol, triglycerides
Time frame: 4 weeks
Central blood pressure
Time frame: 4 weeks
Pulse wave velocity
Time frame: 4 weeks
Brachial blood pressure
Time frame: 4 weeks
Plasma glucose
Time frame: 4 weeks
High-sensitivity C-reactive protein
Time frame: 4 weeks
Serum insulin
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny Kris-Etherton, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dried Fruit and High Carbohydrate Snack in people with Cardiovascular Diseases and Metabolic Syndrome, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL Cholesterol (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.