Hesperidin and Bone Health in Postmenopausal Women

Purdue University

Status: Completed

Conditions: Osteoporosis, Postmenopausal

Treatments: Dietary Supplement: Hesperidin; Dietary Supplement: Hesperidin and Calcilock; Dietary Supplement: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01881204

10.21.NRC

Details and patient eligibility

About

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.

Full 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).

Enrollment: 12 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women at least 4 years postmenopausal

Exclusion criteria

• Medications affecting bone resorption

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 3 patient groups, including a placebo group

Hesperidin and Calcilock

Experimental group

Description:

Subjects will consume 4 cookies containing Hesperidin and Calcilock.

Treatment:

Dietary Supplement: Hesperidin and Calcilock

Hesperidin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Hesperidin

Control

Placebo Comparator group

Description:

Subjects will consume 4 cookies daily without Hesperidin or Calcilock.

Treatment:

Dietary Supplement: Control