Hesperidin and Bone Health in Postmenopausal Women

This study has been completed.
Sponsor:
Collaborator:
Nestec Ltd.
Information provided by (Responsible Party):
Berdine Martin, Purdue University
ClinicalTrials.gov Identifier:
NCT01881204
First received: June 17, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

The primary objective of this clinical trial is to test hesperidin with and without CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary objective is the comparison between 41Ca technology and classical biomarker to evaluate bone resorption.


Condition Intervention
Osteoporosis, Postmenopausal
Dietary Supplement: Hesperidin and Calcilock
Dietary Supplement: Hesperidin
Dietary Supplement: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Hesperidin and Bone Health in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Elimination of 41Calcium in Urine. [ Time Frame: 50 days ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hesperidin and Calcilock
Subjects will consume 4 cookies containing Hesperidin and Calcilock.
Dietary Supplement: Hesperidin and Calcilock
Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).
Experimental: Hesperidin
Subjects will consume 4 cookies containing Hesperidin, 552mg, daily
Dietary Supplement: Hesperidin
Hesperidin (552mg) will be administered in the form of cookies (biscuit).
Placebo Comparator: Control
Subjects will consume 4 cookies daily without Hesperidin or Calcilock.
Dietary Supplement: Control
Cookies without Hesperidin or Calcilock added.

Detailed Description:

Subjects will participate in four phases of the study: Baseline of 50 days and three intervention phases which include 50 days receiving product followed by 50 days of recovery. The total duration of the study will be 350 days. If participant has not been previously labeled with 41Ca, a 150 day period is added to the study.

Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women at least 4 years postmenopausal

Exclusion Criteria:

  • Medications affecting bone resorption
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881204

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Nestec Ltd.
Investigators
Principal Investigator: Connie M Weaver, Ph.D. Purdue University
Study Director: Berdine R Martin, PhD Purdue University
  More Information

No publications provided

Responsible Party: Berdine Martin, Research Scientist, Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT01881204     History of Changes
Other Study ID Numbers: 10.21.NRC
Study First Received: June 17, 2013
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Hesperidin
Osteoporosis
Bone Loss

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014