- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02630797
Effect of Blueberries on Bone Turnover
Berries and Bones: The Effect of Polyphenolic Metabolites From Blueberries on Bone Turnover
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Indiana
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West Lafayette, Indiana, United States, 47907-2059
- Department of Nutrition Science Purdue University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female subject is healthy
- Subject is > 4 years past the onset of natural menopause or total hysterectomy
Exclusion Criteria:
- History of metabolic bone disease or low trauma fractures;
- Subject taking osteoporosis treatment drugs or glucocorticoids within 6 months of the beginning of the study;
- Subjects taking bisphosphonates within 2 years of the beginning of the study;
- History of cancer, thromboembolisms, clotting disorders, uncontrolled hypertension, abnormal thyroid function, malabsorption syndrome, seizure disorders, or heart attack;
- BMI > 35 kg/m2;
- Subjects who will not comply with study interventions ;
- Subjects who will not stop taking natural product supplements of their own selection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Blueberry baseline
No blueberry products provided as part of the usual dietary intake
|
Before the study beginning, eligible participants will receive a radioactive tracer, Ca-41, by iv infusion.
A total of 150 days will be required for the equilibration of tracer in the body i.e. elimination from soft tissue and deposition in the bone.
After equilibration, a baseline period of 42 days will occur, during which no blueberry products will be provided.
|
ACTIVE_COMPARATOR: Blueberry Low
One blueberry product per day containing an equivalent of 0.75 cups of fresh blueberries provided as part of usual dietary intake for 42 days
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One food or beverage product containing freeze-dried blueberry powder equivalent to 0.75 cups of fresh blueberries will be provided daily for 42 days.
|
ACTIVE_COMPARATOR: Blueberry Medium
Two blueberry products per day containing an equivalent of 1.5 cups of fresh blueberries provided as part of usual dietary intake for 42 days
|
Two food or beverage products containing freeze-dried blueberry powder equivalent to 1.5 cups of fresh blueberries will be provided daily for 42 days.
|
ACTIVE_COMPARATOR: Blueberry High
Four blueberry products per day containing an equivalent of 3 cups of fresh blueberries provided as part of usual dietary intake for 42 days
|
Four food or beverage products containing freeze-dried blueberry powder equivalent to 3 cups of fresh blueberries will be provided daily for 42 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ca-41 / Ca ratio in 24-hour urinary excretion to estimate calcium loss from bone
Time Frame: From the beginning of baseline (week 0) to the end of the 3rd washout period (week 42)
|
Urinary Ca-41 excretion will be expressed as Ca-41/Ca ratio, which is unit-less, and converted to a percent change from the baseline value. 24-hour urine will be collected approximately every 2 weeks during baseline (week 0, 2, 4, and 6), weekly (except for week 1) during the low, medium, and high blueberry dose interventions completed in a randomized order (weeks 8-12, 20-24, 32-36) and every 3 weeks during the washout periods (weeks 15, 18, 27, 30, 39, 42). Ca-41/Ca ratios will be measured by Accelerator Mass Spectrometry. |
From the beginning of baseline (week 0) to the end of the 3rd washout period (week 42)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting blood and urine analysis of blueberry polyphenolic metabolites
Time Frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Polyphenol concentrations in urine and serum will be expressed in molar units and compared against reference values and across the study periods. Polyphenolic metabolites will be measured by LC-MSMS. Fasting blood and urine will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42). |
Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Serum and urine biochemical markers of bone metabolism: calcium concentration
Time Frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Calcium concentration in urine and serum will be expressed in mg/L and measured by Atomic Absorption Spectrophotometry. Fasting blood and urine will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42). |
Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Serum biochemical markers of bone metabolism: Insulin Dependent Growth Factor-1 (IGF-1)
Time Frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
IGF-1 will be expressed in ng/mL and measured by ELISA. Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42). |
Weeks 0, 6, 12, 18, 24, 30, 36, 42
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Serum biochemical markers of bone metabolism: Osteoprotegrin
Time Frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Osteoprotegerin will be expressed in pmol/L and measured by ELISA. Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42). |
Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Serum biochemical markers of bone metabolism: RANK ligand
Time Frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
RANK-L will be expressed in pmol/L and measured by ELISA. Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42). |
Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Serum biochemical markers of bone metabolism: 25(OH) Vitamin D
Time Frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
25(OH) Vitamin D will be expressed in ng/mL and measured by LC/MS. Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42). |
Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Serum biochemical markers of bone metabolism: Sclerostin
Time Frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Sclerostin will be expressed in ng/mL and measured by ELISA. Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42). |
Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Urine biochemical markers of bone metabolism: N-terminal telopeptide (NTX)
Time Frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
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NTX will be expressed in ng/mL and measured by ELISA. Fasting urine will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42). |
Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Serum biochemical markers of bone metabolism: procollagen I intact N-terminal (PINP)
Time Frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
PINP will be will be expressed in ug/L and measured by ELISA. Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42). |
Weeks 0, 6, 12, 18, 24, 30, 36, 42
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Connie M Weaver, PhD, Department of Nutrition Science, Purdue University
Publications and helpful links
General Publications
- Chen JR, Lazarenko OP, Wu X, Kang J, Blackburn ML, Shankar K, Badger TM, Ronis MJ. Dietary-induced serum phenolic acids promote bone growth via p38 MAPK/beta-catenin canonical Wnt signaling. J Bone Miner Res. 2010 Nov;25(11):2399-411. doi: 10.1002/jbmr.137.
- Devareddy L, Hooshmand S, Collins JK, Lucas EA, Chai SC, Arjmandi BH. Blueberry prevents bone loss in ovariectomized rat model of postmenopausal osteoporosis. J Nutr Biochem. 2008 Oct;19(10):694-9. doi: 10.1016/j.jnutbio.2007.09.004. Epub 2008 Mar 6.
- Weaver CM, Martin BR, Jackson GS, McCabe GP, Nolan JR, McCabe LD, Barnes S, Reinwald S, Boris ME, Peacock M. Antiresorptive effects of phytoestrogen supplements compared with estradiol or risedronate in postmenopausal women using (41)Ca methodology. J Clin Endocrinol Metab. 2009 Oct;94(10):3798-805. doi: 10.1210/jc.2009-0332. Epub 2009 Jul 7.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BB2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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