A trial evaluating the efficacy of paprika oleoresin intake on bone metabolism: A randomized, placebo-controlled, double-blind, parallel-group comparison trial.

A trial evaluating the efficacy of paprika oleoresin intake on bone metabolism: A randomized, placebo-controlled, double-blind, parallel-group comparison trial. - A trial evaluating the efficacy of paprika oleoresin intake on bone metabolism

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033180

Enrollment

Registered

2019-11-01

Start date

2018-06-29

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Healthy adults

Interventions

Duration: 24 weeks Test material: Soft capsule containing 20 mg of paprika oleoresin Dose: One capsule per day Administration: Take the capsule with water or warm water after breakfast * If yo

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: a) Healthy Japanese women. b) Subjects who are in menopause (natural menopause) for at least 1 year. c) Subjects who are judged as eligible to participate in the study by the physician.

Exclusion criteria

Exclusion criteria: a) Subjects who are diagnosis with osteoporosis (Subjects who have less than 70% in total amount of bone mineral density for lumbar vertebra of YAM score). b) Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction. c) Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases. d) Subjects who take supplements, "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" related to bone metabolism such as calcium, vitamin D, vitamin K, magnesium, and isoflavones (including daidzein, genistein, equol, or etc.) more than once a week. e) Subjects who are currently taking medications (including herbal medicines) and supplements. f) Smoker g) Subjects who are allergic to medicines and/or the test food related products. h) Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial. i) Subjects who are judged as ineligible to participate in the study by the physician.

Design outcomes

Primary

Measure	Time frame
Bone resorption markers; NTX, TRACP-5b (baseline, 12, 24 weeks)	—

Secondary

Measure	Time frame
Bone formation markers; BAP, OC (baseline, 24 weeks) Safety evaluation; Physical examinations, Hematological tests, Blood biochemistry tests, Urinalysis (baseline, 12, 24 weeks)	—

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026