A non-comparative pilot study to evaluate the effect of unpolished rice and/or rice bran intake on mineral metabolism in humans

A non-comparative pilot study to evaluate the effect of phytate intake on mineral metabolism in humans

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003705

Enrollment

Registered

2019-04-02

Start date

2014-12-24

Completion date

Unknown

Last updated

2019-04-23

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

Conditions

None listed

Interventions

Dietary Supplement : Brown rice (medium phytate content, 1.07&#37

) and brown rice mixed with rice bran (high phytate content, 2.17&#37

). All participants completed a 12-day trial that consisted of three successive diet cycles of: (1) polished rice (low phytate content, 0.35&#37

(2) brown rice (medium phytate content, 1.07&#37

and (3) brown rice mixed with rice bran (high phytate content, 2.17&#37

). Each diet cycle lasted for four days.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Premanopausal women aged 20 years or older at the screening, whose serum calcium, phosphorus, and parathyroid hormone levels are withing normal range. Participant who voluntarily agreed to participate in this clnical trial with a written consent after being informed of the current clinical trial.

Exclusion criteria

Exclusion criteria: Potential female participants who reported disorders of bone and mineral metabolism (e.g., hyperparathyroidism, hypoparathyroidism, osteomalacia), previous surgical history that could affect bone and mineral metabolism (e.g., parathyroidectomy, thyroidectomy, gastrectomy), use of any medication that could affect bone and mineral metabolism (e.g., estrogen, bisphosphonates, selective estrogen receptor modulators, calcitonin), use of Ca2+ and vitamin D supplementation within the past three months, use of corticosteroids within the past one month, or acute or chronic renal failure; exhibited abnormal liver function; or were pregnant or lactating, were excluded from participating in the study. Those who principal investigator regarded as inappropriate by any reason including laboratory results were also excluded.

Design outcomes

Primary

Measure	Time frame
Serum calcium;Serum phosphorus;Serum parathyroid hormone;Serum magnesium	—

Secondary

Measure	Time frame
Serum vitamin D (25-hydroxyvitamin D);Serum active vitamin D (1,25-dihydroxyvitamin D);Serum creatinine;Serum glucose;Lipid panel	—

Countries

Korea, Republic of

Contacts

Public ContactHan Seok Choi

Dongguk University Ilsan Hospital

hschoi402@dumc.or.kr+82-31-961-5777

Outcome results