Effect of Blueberries on Bone Turnover

NCT02630797 | Unknown Phase 1 DMC

• 1 other identifier: BB2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses a bone labeling calcium tracer methodology to compare the dose-response effect of blueberry consumption on calcium retention and bone loss. Post-menopausal women will receive food or beverage products containing freeze-dried blueberries in the amount equivalent to 0.75 (low), 1.5 (medium), and 3 cups (high) of fresh blueberries per day over a 42-day period. The hypothesis is that the polyphenolics found in blueberries will reduce calcium loss from bones.

Conditions

Osteoporosis, Postmenopausal; Bone Loss, Age-related

Keywords

Bone Health; Calcium; Osteoporosis; Polyphenolics

Outcome Measures

Primary Outcomes (1)

• Ca-41 / Ca ratio in 24-hour urinary excretion to estimate calcium loss from bone

  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 Outcomes (9)

• Fasting blood and urine analysis of blueberry polyphenolic metabolites

  Weeks 0, 6, 12, 18, 24, 30, 36, 42

• Serum and urine biochemical markers of bone metabolism: calcium concentration

  Weeks 0, 6, 12, 18, 24, 30, 36, 42

• Serum biochemical markers of bone metabolism: Insulin Dependent Growth Factor-1 (IGF-1)

  Weeks 0, 6, 12, 18, 24, 30, 36, 42

• Serum biochemical markers of bone metabolism: Osteoprotegrin

  Weeks 0, 6, 12, 18, 24, 30, 36, 42

• Serum biochemical markers of bone metabolism: RANK ligand

  Weeks 0, 6, 12, 18, 24, 30, 36, 42

Study Arms (4)

Blueberry baseline

PLACEBO COMPARATOR

No blueberry products provided as part of the usual dietary intake

Dietary Supplement: Blueberry Baseline

Blueberry Low

ACTIVE COMPARATOR

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

Dietary Supplement: Blueberry Low

Blueberry Medium

ACTIVE COMPARATOR

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

Dietary Supplement: Blueberry Medium

Blueberry High

ACTIVE COMPARATOR

Four blueberry products per day containing an equivalent of 3 cups of fresh blueberries provided as part of usual dietary intake for 42 days

Dietary Supplement: Blueberry High

Interventions

Blueberry Baseline DIETARY_SUPPLEMENT

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.

Blueberry baseline

Blueberry Low DIETARY_SUPPLEMENT

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.

Blueberry Low

Blueberry Medium DIETARY_SUPPLEMENT

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.

Blueberry Medium

Blueberry High DIETARY_SUPPLEMENT

Four food or beverage products containing freeze-dried blueberry powder equivalent to 3 cups of fresh blueberries will be provided daily for 42 days.

Blueberry High

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subject is healthy
• Subject is \> 4 years past the onset of natural menopause or total hysterectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Department of Nutrition Science Purdue University

West Lafayette, Indiana, 47907-2059, United States

Location

Related Publications (4)

• 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.

  PMID: 20499363 BACKGROUND

• 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.

  PMID: 18328688 BACKGROUND

• 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.

  PMID: 19584189 BACKGROUND

• Hodges JK, Maiz M, Cao S, Lachcik PJ, Peacock M, McCabe GP, McCabe LD, Cladis DP, Jackson GS, Ferruzzi MG, Lila MA, Bailey RL, Martin BR, Weaver CM. Moderate consumption of freeze-dried blueberry powder increased net bone calcium retention compared with no treatment in healthy postmenopausal women: a randomized crossover trial. Am J Clin Nutr. 2023 Aug;118(2):382-390. doi: 10.1016/j.ajcnut.2023.05.033. Epub 2023 Jun 1.

  PMID: 37269909 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Connie M Weaver, PhD

  Department of Nutrition Science, Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist - Study Director

Model Details: This partially randomized crossover design model will include participants assigned first to a control baseline period followed by three intervention phases with a low, medium or high daily dose of blueberry products in a randomized order.

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 15, 2015
• Study Start: January 12, 2017
• Primary Completion: January 1, 2019
• Study Completion: August 1, 2019
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)