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Hesperidin and Bone Health in Postmenopausal Women

Hesperidin and Bone Health in Postmenopausal Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01881204
Acronym
Hesperidin
Enrollment
12
Registered
2013-06-19
Start date
2011-04-30
Completion date
2012-10-31
Last updated
2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal

Keywords

Hesperidin, Osteoporosis, Bone Loss

Brief summary

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

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).

Interventions

DIETARY_SUPPLEMENTHesperidin 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).

DIETARY_SUPPLEMENTHesperidin

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

DIETARY_SUPPLEMENTControl

Cookies without Hesperidin or Calcilock added.

Sponsors

Nestec Ltd.
CollaboratorINDUSTRY
Purdue University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Women at least 4 years postmenopausal

Exclusion criteria

* Medications affecting bone resorption

Design outcomes

Primary

MeasureTime frameDescription
Elimination of 41Calcium in Urine.50 daysAppearance of Ca41 in urine will be measured by Accelerator Mass Spectrometry to represent calcium that is being lost from the skeleton.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026