Insulin SensitivityBLUEBERRYNCT01005420
The Effect of Blueberries on Enhancing Insulin Sensitivity in Humans: A Pilot Study
A study testing Blueberry Powder in people with Insulin Sensitivity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of blueberry powder on insulin sensitivity in obese, non-diabetic, and insulin resistant subjects. The investigators hypothesized that supplementation with blueberry powder will result in an increase in insulin sensitivity in obese subjects with insulin resistance. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Blueberry Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Aug 2009
- 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 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects ≥ 20 years of age.
- Subjects not currently treated with diabetes medication.
- Subjects with fasting blood glucose at time of screening is ≤ 110 mg/dL.
- Subjects with a Body Mass Index (BMI) ≥ 32 and ≤ 45.
- Written Informed Consent obtained PRIOR to performing any screening tests or study procedures.
- Subjects who have glucose disposal rate ≤ 650 mg/min assessed clinically at visit 4
Who cannot join
- Subjects with a prior history of Type 2 diabetes.
- Women who are pregnant or who are lactating.
- Women of childbearing potential who are not using an effective method of birth control, condoms with spermicidal gel or foam, contraceptive patch, are not surgically sterilized, or not at least 2 years postmenopausal.
- Subjects who have type 1 diabetes.
- Subjects who are currently on thiazolidinediones (rosiglitazone or pioglitazone) or who have taken these agents in the previous 12 weeks.
- Subjects who are on concomitant therapy with glucocorticoids (except topical or inhalant glucocorticoids). Other medications that have an effect on glucose homeostasis (i.e. ACE inhibitors) are acceptable if they have been administered in a stable dosage during the preceding 6 months and dosage will continue unchanged during the study.
Show all 24Show fewer
- Subjects with a history or evidence of significant gastrointestinal dysfunction.
- Subjects who have chronic use of laxatives or cathartics. The use of stool softeners is acceptable. Use of bulking agents, if required, should remain constant.
- Subjects who are taking concomitant therapy with medications known to be nephrotoxic, such as aminoglycosides, methicillin, and cyclosporin.
- Subjects who have evidence of clinically significant renal dysfunction or disease, e.g. serum creatinine >1.5 mg/dL in males and >1.4 mg/dL in females and/or BUN >50 mg/dL, proteinuria of >1 gram/day or 4+ proteinuria on dipstick urinalysis.
- Subjects with clinically significant cardiovascular dysfunction and/or history (within the preceding 6 months) of significant cardiovascular dysfunction, e.g., congestive heart failure or serious arrhythmia, myocardial infarction, cardiac surgery; transient ischemic attacks or cerebrovascular accident during the preceding six months; diagnosis of symptomatic autonomic neuropathy with a history of orthostatic hypertension, syncope, or hypertension with a systolic blood pressure of ≥180 mm Hg and diastolic blood pressure ≥110 mm Hg at the time of screening visit.
- Subjects who have evidence within the preceding 6 months of hepatic disease or dysfunction, e.g. AST, ALT, alkaline phosphatase or total bilirubin twice the upper limit of normal; hepatitis; jaundice; cirrhosis.
- Subjects with clinically significant pulmonary, neurologic, hematologic, immunologic, neoplastic or metabolic disease.
- Subjects with evidence or recurrence of malignancy within the past five years, other than excised basal cell carcinoma.
- Subjects for whom surgery is anticipated during the study period.
- Subjects with an history of substance abuse or alcoholism within the past 5 years, or significant psychiatric disorder that would interfere with the subject's ability to complete the study.
- Subjects who have donated blood during the month prior to study entry or planned during the study.
- Subjects who have participated in other studies using an investigational drug during the preceding 3 months.
- Subjects who are current smokers or have smoked within the previous 6 months. No smoking will be allowed during the study.
- Subjects who are allergic to blueberries.
- Subjects who are lactose intolerant.
- Subjects who consume and drink daily servings of berries (i.e., blueberries, strawberries, bilberries, cranberries, elderberries, and raspberries), grapes, fruit juices that contain berries and grapes, and wine more than 3 times per week.
- Subjects that have had a fluctuation in body weight >5% in the preceding 2 months.
- Subjects who are taking prescription or over the counter medication or supplements for desired weight loss.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: The Effect of Anthocyanins in the Form of Blueberry Powder on Enhancing Insulin Sensitivity in Insulin Resistant and Obese Humans
The purpose of this study is to evaluate the effect of blueberry powder on insulin sensitivity in obese, non-diabetic, and insulin resistant subjects. The investigators hypothesized that supplementation with blueberry powder will result in an increase in insulin sensitivity in obese subjects with insulin resistance.
Read the detailed description
Insulin resistance is a key pathophysiologic feature of the "metabolic syndrome" and is strongly associated with co-existing cardiovascular risk factors and accelerated atherosclerosis. Due to the clinical consequences associated with insulin resistance in subjects with metabolic syndrome and type 2 diabetes, clinical regimens directed at increasing insulin sensitivity in vivo remain one of the most desirable goals of treatment. Although it is well established that lifestyle modification can improve insulin resistance and effectively improve many of the risk factors associated with the metabolic syndrome, the success of maintaining lifestyle changes in humans over a chronic period is poor. Therefore, strategies to improve insulin resistance by pharmacological means have represented the traditional approach for clinical medicine. However, because of the widespread use of dietary supplements by the general public, nutritional supplementation with the use of botanical extracts that effectively increase insulin sensitivity represent a very attractive and novel approach.
Unfortunately, considerable controversy exists regarding the effect of botanical supplements on the metabolic syndrome in large part because efficacy data for many of the supplements used for this purpose consists of only uncontrolled studies and anecdotal reports. As such, there is a paucity of data in humans in regard to the effect of botanicals to improve measures of insulin action in vivo or on cellular aspects of insulin action. However, several lines of evidence in both in vitro and in vivo models suggest that botanicals may modulate intracellular pathways of glucose metabolism. Specifically, preclinical data with use of extracts from grapes and blueberries suggest that components of these botanical mixtures, e.g. anthocyanins and resveratrol, may play a role in enhancing cellular pathways of insulin action. On a clinical level, if cellular pathways of insulin action are enhanced, e.g. PI-3 kinase activity, this should be associated with an increase in whole body glucose disposal as reflected in measures assessing insulin sensitivity. However, there is limited experience in human studies for which insulin sensitivity has been assessed with use of "gold standard" techniques assessing in vivo insulin action. Therefore, this project's overall objective is to examine the role of a specific botanical (i.e., blueberry powder) on insulin action in vivo with use of hyperinsulinemic-euglycemic clamps. This pilot trial is designed to evaluate a fixed consumption of blueberry powder and to provide data of the effect so that a larger, more comprehensive study can be planned. To accomplish our goal, we will conduct a randomized, placebo-controlled pilot clinical study with blueberry powder designed to assess insulin sensitivity in subjects who are obese and insulin resistant. We hypothesize that blueberry powder will be effective, when compared to placebo, to increase insulin action in vivo. If so, this pilot trial will provide the necessary background to progress to studies in subjects with Type 2 diabetes. An increase in insulin sensitivity in patients with Type 2 diabetes will be expected to markedly reduce glucose levels.
- Conditions
- Insulin Sensitivity
- Being tested
- Blueberry Powder, Placebo
- Keywords
- Insulin Sensitivity, Pre-diabetes, Diabetes, Blueberries, Anthocyanins
- Medical subject headings
- Insulin Resistance, Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry PowderDietary supplement
The blueberry and placebo groups will be randomized to receive 45g of blueberry powder or control per day. Blueberry powder will be given as a smoothie to be consumed at the breakfast and dinner meals and an identical smoothie will be given as a control. The smoothies will be prepared in the metabolic kitchen and a week supply of frozen smoothies will be given to participants. Both the blueberry powder and control smoothie contain comparable energy and macronutrients.
PlaceboDietary supplement
The blueberry and placebo groups will be randomized to receive 45g of blueberry powder or control per day. Blueberry powder will be given as a smoothie to be consumed at the breakfast and dinner meals and an identical smoothie will be given as a control. The smoothies will be prepared in the metabolic kitchen and a week supply of frozen smoothies will be given to participants. Both the blueberry powder and control smoothie contain comparable energy and macronutrients.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry Powder | Experimental | A blueberry smoothie will be consumed at the breakfast and dinner meals.
Nutritional Value:(based on one 16oz smoothie and subjects had to consume two a day)
* 206.4 Kcals
* 40.3 g Carbohydrate
* 11.5 g Protein
* 0.08 g Fat
* 0.05 g Sat fat
* 4.2 g Fiber
Ingredients:
* 245.0 g Dannon Light \& Fit yogurt
* 105 .0 g Skim milk
* 22.5 g Freeze-dried blueberry powder
* 5.0 g Imitation vanilla flavor
* 1.0 g Splenda
* 16 oz plastic cup with lid
* Smoothie total weight - 378.5 g Receives: Dietary Supplement: Blueberry Powder |
| Placebo | Placebo comparator | A placebo smoothie will be consumed at the breakfast and dinner meals.
Nutritional Value:(based on one 16oz smoothie and subjects had to consume two a day)
* 201.3 Kcals
* 40.3 g Carbohydrate
* 10.7 g Protein
* 0.08 g Fat
* 0.05 g Sat fat
* 4.3 g Fiber
Ingredients:
* 245.0 g Dannon Light \& Fit yogurt
* 105 .0 g Skim milk
* 5.0 g Benefiber
* 12.0 g Sugar
* 4.0 g Artificial blueberry flavor(liquid \& powder)
* 1.5 g Red food color
* 0.7 g Blue food color
* 16 oz plastic cup with lid
* Smoothie total weight - 373.2 g Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Measured: before intervention (Week 0) and 6 weeks after intervention started
Secondary outcomes (1)
Cognitive Performance
Measured: screening and 5 weeks after intevention started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startFeb 2007
- Primary completionJun 2009
- Study completionAug 2009
Why it stopped: No participants were enrolled and was closed in IRB February 24, 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William T Cefalu, MD, Principal investigator, Pennington Biomedical Research CenterApril Stull, Ph.D., Study director, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005420
- Sponsor's protocol ID
- PBRC 27030
- Acronym
- BLUEBERRY
- Status last verified
- Sep 2022
- First submitted
- 29 Oct 2009
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Stull AJ, Cash KC, Johnson WD, Champagne CM, Cefalu WT. Bioactives in blueberries improve insulin sensitivity in obese, insulin-resistant men and women. J Nutr. 2010 Oct;140(10):1764-8. doi: 10.3945/jn.110.125336. Epub 2010 Aug 19.
PubMed 20724487
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anthocyanins in the Form of Blueberry Powder on Enhancing Insulin Sensitivity in Insulin Resistant and Obese Humans
- ClinicalTrials.gov ID
- NCT01005420
- Acronym / sponsor ID
- BLUEBERRY / PBRC 27030
- Conditions
- Insulin Sensitivity
- Keywords
- Insulin Sensitivity, Pre-diabetes, Diabetes, Blueberries, Anthocyanins
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled and was closed in IRB February 24, 2015
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Nov 2009 (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 purpose of this study is to evaluate the effect of blueberry powder on insulin sensitivity in obese, non-diabetic, and insulin resistant subjects. The investigators hypothesized that supplementation with blueberry powder will result in an increase in insulin sensitivity in obese subjects with insulin resistance.
Detailed description
Insulin resistance is a key pathophysiologic feature of the "metabolic syndrome" and is strongly associated with co-existing cardiovascular risk factors and accelerated atherosclerosis. Due to the clinical consequences associated with insulin resistance in subjects with metabolic syndrome and type 2 diabetes, clinical regimens directed at increasing insulin sensitivity in vivo remain one of the most desirable goals of treatment. Although it is well established that lifestyle modification can improve insulin resistance and effectively improve many of the risk factors associated with the metabolic syndrome, the success of maintaining lifestyle changes in humans over a chronic period is poor. Therefore, strategies to improve insulin resistance by pharmacological means have represented the traditional approach for clinical medicine. However, because of the widespread use of dietary supplements by the general public, nutritional supplementation with the use of botanical extracts that effectively increase insulin sensitivity represent a very attractive and novel approach.
Unfortunately, considerable controversy exists regarding the effect of botanical supplements on the metabolic syndrome in large part because efficacy data for many of the supplements used for this purpose consists of only uncontrolled studies and anecdotal reports. As such, there is a paucity of data in humans in regard to the effect of botanicals to improve measures of insulin action in vivo or on cellular aspects of insulin action. However, several lines of evidence in both in vitro and in vivo models suggest that botanicals may modulate intracellular pathways of glucose metabolism. Specifically, preclinical data with use of extracts from grapes and blueberries suggest that components of these botanical mixtures, e.g. anthocyanins and resveratrol, may play a role in enhancing cellular pathways of insulin action. On a clinical level, if cellular pathways of insulin action are enhanced, e.g. PI-3 kinase activity, this should be associated with an increase in whole body glucose disposal as reflected in measures assessing insulin sensitivity. However, there is limited experience in human studies for which insulin sensitivity has been assessed with use of "gold standard" techniques assessing in vivo insulin action. Therefore, this project's overall objective is to examine the role of a specific botanical (i.e., blueberry powder) on insulin action in vivo with use of hyperinsulinemic-euglycemic clamps. This pilot trial is designed to evaluate a fixed consumption of blueberry powder and to provide data of the effect so that a larger, more comprehensive study can be planned. To accomplish our goal, we will conduct a randomized, placebo-controlled pilot clinical study with blueberry powder designed to assess insulin sensitivity in subjects who are obese and insulin resistant. We hypothesize that blueberry powder will be effective, when compared to placebo, to increase insulin action in vivo. If so, this pilot trial will provide the necessary background to progress to studies in subjects with Type 2 diabetes. An increase in insulin sensitivity in patients with Type 2 diabetes will be expected to markedly reduce glucose levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry Powder | Experimental | Dietary Supplement: Blueberry PowderA blueberry smoothie will be consumed at the breakfast and dinner meals. Nutritional Value:(based on one 16oz smoothie and subjects had to consume two a day) * 206.4 Kcals * 40.3 g Carbohydrate * 11.5 g Protein * 0.08 g Fat * 0.05 g Sat fat * 4.2 g Fiber Ingredients: * 245.0 g Dannon Light \& Fit yogurt * 105 .0 g Skim milk * 22.5 g Freeze-dried blueberry powder * 5.0 g Imitation vanilla flavor * 1.0 g Splenda * 16 oz plastic cup with lid * Smoothie total weight - 378.5 g |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboA placebo smoothie will be consumed at the breakfast and dinner meals. Nutritional Value:(based on one 16oz smoothie and subjects had to consume two a day) * 201.3 Kcals * 40.3 g Carbohydrate * 10.7 g Protein * 0.08 g Fat * 0.05 g Sat fat * 4.3 g Fiber Ingredients: * 245.0 g Dannon Light \& Fit yogurt * 105 .0 g Skim milk * 5.0 g Benefiber * 12.0 g Sugar * 4.0 g Artificial blueberry flavor(liquid \& powder) * 1.5 g Red food color * 0.7 g Blue food color * 16 oz plastic cup with lid * Smoothie total weight - 373.2 g |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects ≥ 20 years of age.
- Subjects not currently treated with diabetes medication.
- Subjects with fasting blood glucose at time of screening is ≤ 110 mg/dL.
- Subjects with a Body Mass Index (BMI) ≥ 32 and ≤ 45.
- Written Informed Consent obtained PRIOR to performing any screening tests or study procedures.
Key exclusion criteria (24 listed)
- Subjects with a prior history of Type 2 diabetes.
- Women who are pregnant or who are lactating.
- Women of childbearing potential who are not using an effective method of birth control, condoms with spermicidal gel or foam, contraceptive patch, are not surgically sterilized, or not at least 2 years postmenopausal.
- Subjects who have type 1 diabetes.
- Subjects who are currently on thiazolidinediones (rosiglitazone or pioglitazone) or who have taken these agents in the previous 12 weeks.
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 |
|---|---|---|
| Blueberry PowderThe blueberry and placebo groups will be randomized to receive 45g of blueberry powder or control per day. Blueberry powder will be given as a smoothie to be consumed at the breakfast and dinner meals and an identical smoothie will be given as a control. The smoothies will be prepared in the metabolic kitchen and a week supply of frozen smoothies will be given to participants. Both the blueberry powder and control smoothie contain comparable energy and macronutrients. | Dietary supplement | Blueberry Powder |
| PlaceboThe blueberry and placebo groups will be randomized to receive 45g of blueberry powder or control per day. Blueberry powder will be given as a smoothie to be consumed at the breakfast and dinner meals and an identical smoothie will be given as a control. The smoothies will be prepared in the metabolic kitchen and a week supply of frozen smoothies will be given to participants. Both the blueberry powder and control smoothie contain comparable energy and macronutrients. | Dietary supplement | Placebo |
Primary outcome
Insulin Sensitivity
Time frame: before intervention (Week 0) and 6 weeks after intervention started
1 secondary outcome
Cognitive Performance
Time frame: screening and 5 weeks after intevention started
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Derived from this study: PubMed 20724487Stull AJ, Cash KC, Johnson WD, Champagne CM, Cefalu WT. Bioactives in blueberries improve insulin sensitivity in obese, insulin-resistant men and women. J Nutr. 2010 Oct;140(10):1764-8. doi: 10.3945/jn.110.125336. Epub 2010 Aug 19.
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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.
William T Cefalu, MD principal investigator
Pennington Biomedical Research Center
April Stull, Ph.D. study director
Pennington Biomedical 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 Blueberry Powder in people with Insulin Sensitivity, run by Pennington Biomedical 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 24 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: withdrawn, as of the sponsor's last update on 12 Jun 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. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Insulin Sensitivity (time frame: before intervention (Week 0) and 6 weeks after intervention started). 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 NCT01005420, 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 12 Jun 2023.