The Effect of Blueberries on Enhancing Insulin Sensitivity in Humans: A Pilot Study

NCT01005420 | Withdrawn

• 1 other identifier: PBRC 27030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insulin Sensitivity

Keywords

Insulin Sensitivity; Pre-diabetes; Diabetes; Blueberries; Anthocyanins

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  before intervention (Week 0) and 6 weeks after intervention started

Secondary Outcomes (1)

• Cognitive Performance

  screening and 5 weeks after intevention started

Study Arms (2)

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

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

Dietary Supplement: Placebo

Interventions

Blueberry Powder DIETARY_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.

Blueberry Powder

Placebo DIETARY_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.

Placebo

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• 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.

  PMID: 20724487 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Endocrine System Diseases

Study Officials

• William T Cefalu, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• April Stull, Ph.D.

  Pennington Biomedical Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: November 2, 2009
• Study Start: February 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 12, 2023

Record last verified: 2022-09

Locations

US (1)