Hesperidin and Bone Health in Postmenopausal Women

NCT ID: NCT01881204

Last Updated: 2018-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hesperidin and Calcilock

Subjects will consume 4 cookies containing Hesperidin and Calcilock.

Group Type EXPERIMENTAL

Hesperidin and Calcilock

Intervention Type DIETARY_SUPPLEMENT

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).

Hesperidin

Subjects will consume 4 cookies containing Hesperidin, 552mg, daily

Group Type EXPERIMENTAL

Hesperidin

Intervention Type DIETARY_SUPPLEMENT

Hesperidin (552mg) will be administered in the form of cookies (biscuit).

Control

Subjects will consume 4 cookies daily without Hesperidin or Calcilock.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Cookies without Hesperidin or Calcilock added.

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

Hesperidin

Hesperidin (552mg) will be administered in the form of cookies (biscuit).

Intervention Type DIETARY_SUPPLEMENT

Control

Cookies without Hesperidin or Calcilock added.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Women at least 4 years postmenopausal

Exclusion Criteria

* Medications affecting bone resorption
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nestec Ltd.

INDUSTRY

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Berdine Martin

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Connie M Weaver, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Berdine R Martin, PhD

Role: STUDY_DIRECTOR

Purdue University

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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Martin BR, McCabe GP, McCabe L, Jackson GS, Horcajada MN, Offord-Cavin E, Peacock M, Weaver CM. Effect of Hesperidin With and Without a Calcium (Calcilock) Supplement on Bone Health in Postmenopausal Women. J Clin Endocrinol Metab. 2016 Mar;101(3):923-7. doi: 10.1210/jc.2015-3767. Epub 2016 Jan 11.

Reference Type DERIVED
PMID: 26751193 (View on PubMed)

Other Identifiers

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10.21.NRC

Identifier Type: -

Identifier Source: org_study_id

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