DiabetesPhase 2NCT02224365
The Effects of Apple Consumption on Cardiovascular Health in Prediabetics and Type 2 Diabetics
A Phase 2 study testing Apple in people with Diabetes and Cardiovascular Diseases, run by Florida State University at 1 site in United States.
Trial summary
The hypothesis of this study is that the daily consumption of 75 g dried apple powder for twelve weeks will improve arterial stiffness and blood pressure by improving endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering biochemical markers associated with cardiovascular risk and… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetes, Cardiovascular Diseases, Prediabetes
- What is being tested?
- Apple
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2016
- Phase
- Phase 2
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (1 to 10 years postmenopausal)
- Aged 45-65 years
- Prediabetes or Type 2 Diabetes (Hemoglobin A1c ≥ 5.7%)
- Overweight or obese (body mass index between 25 and 40 kg/m2)
Who cannot join
- Diagnosed cardiovascular disease
- Uncontrolled hypertension (≥ 160/100 mmHg)
- Other active chronic diseases such as cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease
- Participating in a weight loss program
- Heavy smokers (> 20 cigarettes per day)
- Heavy drinkers (> 12 alcoholic drinks per week)
- Consumption of more than two apples per week
- Body mass index less than 25 or greater than 40 kg/m2)
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Regular Apple Consumption Improves Cardiovascular Risk Factors and Glycemic Control in Overweight and Obese Prediabetics and Type 2 Diabetics
The hypothesis of this study is that the daily consumption of 75 g dried apple powder for twelve weeks will improve arterial stiffness and blood pressure by improving endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering biochemical markers associated with cardiovascular risk and glycemic control compared to a macronutrient-matched control powder. 50 men and women between the ages of 45 and 65 with prediabetes or type 2 diabetes who are overweight or obese will be included in the study. After a two-week run-in phase, eligible men and women will be randomly assigned to one of two treatment groups: 1) 75 g dried apple powder; or 2) 75 g placebo powder daily for twelve weeks. After an initial telephone screening, all participants will be requested to report to the study site for their first visit. On the first visit (screening), participants will be provided with verbal and written explanation of the project. They will then be asked to sign an informed consent form, followed by measuring fasting glucose levels and a medical history questionnaire to confirm prediabetes or type 2 diabetes. Baseline assessments will be performed for medical history, medication use, dietary intake, and physical activity. Qualified participants will be scheduled for their second visit two weeks later (actual baseline data collection) and randomly assigned to their treatment group. On the second (baseline) visit between the hours of 6:00-11:00 A.M., blood pressure and vascular function will be measured followed by blood draw and urine collection. Anthropometrics will be measured. Participants will be provided with their assigned treatment and will receive standard instructions on how to fill out daily diaries for their treatment, and for food and physical activity records. Blood pressure, vascular function, blood draw, urine collection, and anthropometric, body composition, diet, and physical activity assessments will be repeated at 6- (third visit), and 12-week (final visit) intervals. All cardiovascular measurements will be performed between 6:00 to 11:00 A.M., in a quiet temperature-controlled room in the supine position after an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.
- Conditions
- Diabetes, Cardiovascular Diseases, Prediabetes
- Being tested
- Apple, Placebo
- Keywords
- Diabetes, Arterial Stiffness, Blood Pressure, Endothelial Function, Body Composition, Glycemic Control, Apples, Functional Foods, Polyphenols, Fiber
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppleDietary supplement
12 weeks of 75 g dried apple powder taken in 480 ml per day.
PlaceboDietary supplement
12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.
| Study group | Role | What they receive |
|---|---|---|
| Apple | Experimental | 12 weeks of 75 g dried apple powder taken in 480 ml per day. Receives: Dietary Supplement: Apple |
| Placebo | Placebo comparator | 12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Measured: 12 weeks
Secondary outcomes (8)
Arterial Stiffness
By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Measured: 12 weeks
Autonomic Control of Blood Pressure
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.
Measured: 12 weeks
Endothelial-mediated Vasodilation
By measuring flow-mediated dilation in the brachial artery.
Measured: 12 weeks
Inflammation
By measuring markers of inflammation.
Measured: 12 weeks
Oxidative Stress
By measuring markers of oxidative stress.
Measured: 12 weeks
Insulin Sensitivity
By measuring fasting glucose, insulin, homeostatic model of insulin resistance, and hemoglobin A1C.
Measured: 12 weeks
Atherogenic Markers
By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.
Measured: 12 weeks
Body Composition
By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Florida 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Apple Association
- Responsible party
- Principal investigator, Bahram Arjmandi, Florida State University
- Investigators
- Bahram H. Arjmandi, PhD, RD, Principal investigator, Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State UniversityArturo Figueroa, MD, PhD, Principal investigator, Department of Nutrition, Food and Exercise Sciences, Florida State UniversitySarah A. Johnson, PhD, RDN, Principal investigator, Department of Food Science and Human Nutrition, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224365
- Sponsor's protocol ID
- RF02435
- Other IDs
- 2015.14930, 2015
- Status last verified
- Dec 2016
- First submitted
- 21 Aug 2014
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Apple Consumption Improves Cardiovascular Risk Factors and Glycemic Control in Overweight and Obese Prediabetics and Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT02224365
- Acronym / sponsor ID
- RF02435
- Conditions
- Diabetes, Cardiovascular Diseases, Prediabetes
- Keywords
- Diabetes, Arterial Stiffness, Blood Pressure, Endothelial Function, Body Composition, Glycemic Control, Apples, Functional Foods
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- U.S. Apple Association
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Aug 2014 (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.
The hypothesis of this study is that the daily consumption of 75 g dried apple powder for twelve weeks will improve arterial stiffness and blood pressure by improving endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering biochemical markers associated with cardiovascular risk and glycemic control compared to a macronutrient-matched control powder. 50 men and women between the ages of 45 and 65 with prediabetes or type 2 diabetes who are overweight or obese will be included in the study. After a two-week run-in phase, eligible men and women will be randomly assigned to one of two treatment groups: 1) 75 g dried apple powder; or 2) 75 g placebo powder daily for twelve weeks. After an initial telephone screening, all participants will be requested to report to the study site for their first visit. On the first visit (screening), participants will be provided with verbal and written explanation of the project. They will then be asked to sign an informed consent form, followed by measuring fasting glucose levels and a medical history questionnaire to confirm prediabetes or type 2 diabetes. Baseline assessments will be performed for medical history, medication use, dietary intake, and physical activity. Qualified participants will be scheduled for their second visit two weeks later (actual baseline data collection) and randomly assigned to their treatment group. On the second (baseline) visit between the hours of 6:00-11:00 A.M., blood pressure and vascular function will be measured followed by blood draw and urine collection. Anthropometrics will be measured. Participants will be provided with their assigned treatment and will receive standard instructions on how to fill out daily diaries for their treatment, and for food and physical activity records. Blood pressure, vascular function, blood draw, urine collection, and anthropometric, body composition, diet, and physical activity assessments will be repeated at 6- (third visit), and 12-week (final visit) intervals. All cardiovascular measurements will be performed between 6:00 to 11:00 A.M., in a quiet temperature-controlled room in the supine position after an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apple | Experimental | Dietary Supplement: Apple12 weeks of 75 g dried apple powder taken in 480 ml per day. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women (1 to 10 years postmenopausal)
- Aged 45-65 years
- Prediabetes or Type 2 Diabetes (Hemoglobin A1c ≥ 5.7%)
- Overweight or obese (body mass index between 25 and 40 kg/m2)
Key exclusion criteria (8 listed)
- Diagnosed cardiovascular disease
- Uncontrolled hypertension (≥ 160/100 mmHg)
- Other active chronic diseases such as cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease
- Participating in a weight loss program
- Heavy smokers (> 20 cigarettes per day)
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 |
|---|---|---|
| Apple12 weeks of 75 g dried apple powder taken in 480 ml per day. | Dietary supplement | Apple |
| Placebo12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day. | Dietary supplement | Placebo |
Primary outcome
Blood Pressure
Time frame: 12 weeks
By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
8 secondary outcomes
Arterial Stiffness
Time frame: 12 weeks
Autonomic Control of Blood Pressure
Time frame: 12 weeks
Endothelial-mediated Vasodilation
Time frame: 12 weeks
Inflammation
Time frame: 12 weeks
Oxidative Stress
Time frame: 12 weeks
Insulin Sensitivity
Time frame: 12 weeks
Atherogenic Markers
Time frame: 12 weeks
Body Composition
Time frame: 12 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 8 Dec 2016.
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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.
Bahram H. Arjmandi, PhD, RD principal investigator
Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
Arturo Figueroa, MD, PhD principal investigator
Department of Nutrition, Food and Exercise Sciences, Florida State University
Sarah A. Johnson, PhD, RDN principal investigator
Department of Food Science and Human Nutrition, Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apple in people with Diabetes and Cardiovascular Diseases, run by Florida 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 4 inclusion and 8 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 8 Dec 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood Pressure (time frame: 12 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 8 Dec 2016.