A pilot study to evaluate the effects of the lactoferrin formulation on bone mineral density in postmenopausal females

Not Applicable

• Conditions: Healthy volunteers

• Registration Number: JPRN-UMIN000040966
• Lead Sponsor: Soiken Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-19
• Study Completion: 2021-03-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

1) Subjects receiving medical treatments for osteoporosis 2) Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine, metabolic disorders or a medical history of these disorders 3) Subjects who take regularly pharmaceuticals and quasi-drugs which have the efficacy for bone mineral density or bone metabolism 4) Subjects who take regularly Foods for Specified Health Uses, Foods with Function Claims and supplements which have the possibility of the effects on bone mineral density or bone metabolism 5) Subjects who have the possibility of developing allergic symptoms by the test food 6) Subjects having blood sample of 200 ml or more taken within one month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 7) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 8) Subjects deemed unsuitable by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone mineral density (lumber spine (L2-L4), proximal femur)

Secondary Outcome Measures

Name	Time	Method
Blood analysis (BAP, TRACP-5b, NTX)