Cardiovascular Risk FactorsNCT01260272
Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects
A study testing Alternative Snack Comparator and Raisins in people with Cardiovascular Risk Factors, run by Louisville Metabolic and Atherosclerosis Research Center at 1 site in United States.
Trial summary
This trial compared the effects of raisin intake on cardiovascular risk factors compared to common, commercially available, alternative snacks. These cardiovascular risk factors include glucose, blood pressure, lipid levels, body weight, and waist circumference. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Alternative Snack Comparator and Raisins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are generally healthy men and women older than 18 years of age.
- Are willing and able to undergo the informed consent process.
- Have body mass index (BMI) from 25.0 to 34.9 kg/m².
- Have one or more fasting plasma or serum glucose values of 90-150 mg/dl documented within 4 weeks of the initial study visit, or upon safety lab evaluation at the initial study visit.
- Have blood pressure > 120 mmHg systolic or > 80 mmHg diastolic.
- Are willing to notify the research staff of any change in their medical health \& concomitant medications/supplements during the course of the clinical trial.
Who cannot join
- Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients.
- History of > one "food allergy."
- Weight loss of > 5 pounds in last 2 months
- Prior diagnosis of diabetes mellitus or currently taking diabetes mellitus drugs (including drugs such as metformin and colesevelam HCl, even if not being taken for diabetes mellitus). Subjects with prior history of gestational diabetes mellitus are eligible, as long as they no longer have diabetes mellitus, and are no longer taking medications for diabetes mellitus.
- Blood pressure >160 mmHg systolic or >100 mmHg diastolic.
- Fasting serum lipoprotein values of: LDL-cholesterol, >160 mg/dl or triglycerides, >500 mg/dl.
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- Creatinine level > 1.5 times the upper range of normal.
- Potassium level above the upper range of normal (one repeat lab would be permitted if the initial elevated potassium level is thought possibly due to laboratory error)
- Use of any medication or supplement to treat diabetes mellitus or blood glucose management at, or within 2 months prior to initial study entry.
- Initiation or change of any antihypertensive medication within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two antihypertensive medications that is/are to be maintained at constant dose throughout the study.
- Initiation or change of any lipid-altering drug within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two lipid-altering drugs that is/are to be maintained at constant dose throughout the study.
- Is pregnant, breastfeeding or plans to become pregnant during the next three months.
- Is an employee or immediate family member of the research staff.
- Donated blood within 2 months prior to study entry, or plans to donate blood during the course of this study.
- Use of systemic corticosteroids (intravenous, subcutaneous, intra-articular). Inhaled and intranasal corticosteroids are permitted.
- Use of antiobesity/weight maintenance drug therapies at initial study visit, or within 2 months of the initial study visit.
- Known medical history of clinical significance, or any other conditions that would present unacceptable risk to study subject, compromise the acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study as per discretion of the Principal Investigator.
- History of severe or uncontrolled depression based on Principal Investigator.
- Known laboratory abnormalities prior to randomization which Principal Investigator deems may pose an unacceptable risk, compromise acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.
- Major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the informed consent document), or current plans to have a major surgical procedure during study participation or 30 days following completion of all study related procedures.
- History of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, etc.) or history of a gastric bypass or other diversional bariatric surgery. Gastric banding procedure is also exclusionary if adjusted within 30 days prior to visit #1 (i.e. day of signing the informed consent document), or a reasonable chance of having a gastric banding adjustment during the course of the study.
- History of ongoing malignancy. Malignancy that has been successfully treated, with no evidence of persistence or recurrence of the malignancy within 5 years of visit #1 (i.e. day of signing the informed consent document) or basal carcinoma of the skin and "in situ" cancer of the cervix successfully treated 30 days prior to visit #1 are acceptable.
- History of organ transplant.
- History of drug (licit or illicit) or alcohol abuse/addiction within 5 years of visit #1 (i.e. day of signing the informed consent document).
- Consumes more than 2 units of alcohol per day. A unit of alcohol is defined as a 12 ounce (350 ml) beer, 5 ounce (150 ml) wine, or 1.5 ounce (45 ml) of 80-proof alcohol for mixed drinks.
- Known positive testing for hepatitis B surface antigen, hepatitis C antibody, active hepatitis A immunoglobulin M, or human immunodeficiency virus.
- Anticipation of a significant change in job, job duties, or job work hours, which might impair their ability and willingness to undergo study-related procedures under the timelines specified by protocol, and otherwise impede their completion of the study.
- Anticipation of or a reasonable likelihood of moving away from the research site, wherein such a move might impair their ability and willingness to undergo study-related procedures within the timelines specified by protocol, or otherwise impede their completion of the study.
- Anticipation of or a reasonable likelihood of vacations or other times away from home which might impair their ability and willingness to undergo study-related procedures within the timelines specified by the study protocol, or otherwise impede their completion of the study.
- Planned or anticipated major changes in lifestyle health practices, unless allowed by study protocol. Therapeutic Lifestyle Changes counseling will take place at randomization.
- Treatment with an investigational product or an investigational device within 30 days prior to visit #1 (i.e. day of signing the informed consent document) and have no plans to potentially start any investigational product or use an investigational device during or 30 days after the study subject completes all study related procedures.
- Reasonable life-expectancy of less than 2 years.
- Any other reason, if in the opinion of the Investigator, the individual study subject is not appropriate, or suitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, 40213
About this study
Official title: A Randomized, Unblinded, Single Research Site, Comparator Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects
This trial compared the effects of raisin intake on cardiovascular risk factors compared to common, commercially available, alternative snacks. These cardiovascular risk factors include glucose, blood pressure, lipid levels, body weight, and waist circumference.
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Alternative Snack Comparator, Raisins
- Keywords
- Cardiovascular, Risk Factors, Cardiovascular Disease, Glucose, Blood Pressure, BMI, Weight, Waist Circumference
- Medical subject headings
- Cardiovascular Diseases, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative Snack ComparatorOther
Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers
RaisinsOther
Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
| Study group | Role | What they receive |
|---|---|---|
| Alternative Snack Group | Active comparator | This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables Receives: Other: Alternative Snack Comparator |
| Raisin Group | Experimental | This group will receive raisins to consume three times a day with meals Receives: Other: Raisins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Postprandial Glucose Levels
Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12
Measured: 12 weeks
Percent Change in Fasting Glucose Levels
Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12
Measured: 12 weeks
Percent Change in Body Weight
Raisin versus snacks: percent change in body weight from baseline to week 12
Measured: 12 weeks
Secondary outcomes (5)
Change in Systolic Blood Pressure
Raisin versus snacks: change in systolic blood pressure from baseline to week 12
Measured: 12 weeks
Change in Diastolic Blood Pressure
Raisin versus snacks: change in diastolic blood pressure from baseline to week 12
Measured: 12 weeks
Change in Hemoglobin A1c
Raisin versus snacks: change in hemoglobin A1c from baseline to week 12
Measured: 12 weeks
Change in Waist Circumference
Raisin versus snacks: change in waist circumference from baseline to week 12
Measured: 12 weeks
Change in High Density Lipoprotein Cholesterol Levels
Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12
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 posted15 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisville Metabolic and Atherosclerosis Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- California Raisin Marketing Board
- Responsible party
- Principal investigator, Harold E. Bays, Louisville Metabolic and Atherosclerosis Research Center
- Investigators
- Harold E. Bays, MD, Principal investigator, Louisville Metabolic and Atherosclerosis Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260272
- Sponsor's protocol ID
- 001
- Status last verified
- Apr 2014
- First submitted
- 13 Dec 2010
- Last updated
- 29 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Anderson JW, Weiter KM, Christian AL, Ritchey MB, Bays HE. Raisins compared with other snack effects on glycemia and blood pressure: a randomized, controlled trial. Postgrad Med. 2014 Jan;126(1):37-43. doi: 10.3810/pgm.2014.01.2723.
PubMed 24393750
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Unblinded, Single Research Site, Comparator Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects
- ClinicalTrials.gov ID
- NCT01260272
- Acronym / sponsor ID
- 001
- Conditions
- Cardiovascular Risk Factors
- Keywords
- Cardiovascular, Risk Factors, Cardiovascular Disease, Glucose, Blood Pressure, BMI, Weight, Waist Circumference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Louisville Metabolic and Atherosclerosis Research CenterUniversity, hospital or other
- Collaborators
- California Raisin Marketing Board
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Posted 1 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial compared the effects of raisin intake on cardiovascular risk factors compared to common, commercially available, alternative snacks. These cardiovascular risk factors include glucose, blood pressure, lipid levels, body weight, and waist circumference.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative Snack Group | Active comparator | Other: Alternative Snack ComparatorThis group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables |
| Raisin Group | Experimental | Other: RaisinsThis group will receive raisins to consume three times a day with meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are generally healthy men and women older than 18 years of age.
- Are willing and able to undergo the informed consent process.
- Have body mass index (BMI) from 25.0 to 34.9 kg/m².
- Have one or more fasting plasma or serum glucose values of 90-150 mg/dl documented within 4 weeks of the initial study visit, or upon safety lab evaluation at the initial study visit.
- Have blood pressure > 120 mmHg systolic or > 80 mmHg diastolic.
Key exclusion criteria (33 listed)
- Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients.
- History of > one "food allergy."
- Weight loss of > 5 pounds in last 2 months
- Prior diagnosis of diabetes mellitus or currently taking diabetes mellitus drugs (including drugs such as metformin and colesevelam HCl, even if not being taken for diabetes mellitus). Subjects with prior history of gestational diabetes mellitus are eligible, as long as they no longer have diabetes mellitus, and are no longer taking medications for diabetes mellitus.
- Blood pressure >160 mmHg systolic or >100 mmHg diastolic.
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 |
|---|---|---|
| Alternative Snack ComparatorAny prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers | Other | Alternative Snack Group |
| RaisinsRaisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium. | Other | Raisin Group |
Primary outcome
Percent Change in Postprandial Glucose Levels
Time frame: 12 weeks
Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12
Percent Change in Fasting Glucose Levels
Time frame: 12 weeks
Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12
Percent Change in Body Weight
Time frame: 12 weeks
Raisin versus snacks: percent change in body weight from baseline to week 12
5 secondary outcomes
Change in Systolic Blood Pressure
Time frame: 12 weeks
Change in Diastolic Blood Pressure
Time frame: 12 weeks
Change in Hemoglobin A1c
Time frame: 12 weeks
Change in Waist Circumference
Time frame: 12 weeks
Change in High Density Lipoprotein Cholesterol Levels
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24393750Anderson JW, Weiter KM, Christian AL, Ritchey MB, Bays HE. Raisins compared with other snack effects on glycemia and blood pressure: a randomized, controlled trial. Postgrad Med. 2014 Jan;126(1):37-43. doi: 10.3810/pgm.2014.01.2723.
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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.
Harold E. Bays, MD principal investigator
Louisville Metabolic and Atherosclerosis Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternative Snack Comparator and Raisins in people with Cardiovascular Risk Factors, run by Louisville Metabolic and Atherosclerosis Research Center 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 6 inclusion and 33 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 29 Apr 2014. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Postprandial Glucose Levels (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01260272, which also lists 1 linked publication.
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 29 Apr 2014.