Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause

Phase II Study of Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause: a Randomised Double Blind Placebo-Controlled Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00290212

Enrollment

304

Registered

2006-02-10

Start date

2006-01-31

Completion date

2007-06-30

Last updated

2008-01-24

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

Conditions

Perimenopausal Bone Loss

Keywords

Women, Bone density, Menopause, Dietary Supplements, Vitamin K2

Brief summary

Study Objective: To determine whether Natto supplementation in women immediately after menopause might prevent severe bone loss Study population: Women 50 - 60 years, 1-5 years after menopause Study Design: Double-blind, placebo-controlled, randomized controlled trial. A phase II clinical trial. Instruments Used to Measure Therapeutic Response: Lunar Prodigy DEXA bone densitometer Study Treatment Group: Daily supplementation with Vitamin K2, NATTO Study Control Group: Identically-looking placebo medication Duration of treatment: 12 months Duration of Subject Participation in Study: 12 months Assessment of Therapeutic response: Given an expected reduction of bone mass density of - 1.1% annually in the placebo group, the minimum clinically significant difference between the groups is 0.3 percentage points. The trial is therefore powered to detect a reduction in annual bone mass loss of 0.3 percentage points in the treatment group. Numbers of Evaluable Subjects Required: 304 Maximum # Subjects 334

Interventions

DRUGNatto capsules (food suppl.) cont. 360 microg. vit K2/day

DRUGPlacebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Women living in the city of Tromsø, not using hormone replacement therapy, 1-5 years after menopause.

Exclusion criteria

* History of hip fracture * Bone disease affecting bone mineral density * Use of vitamin K antagonists * Significant co-morbidity that makes it difficult to obtain BMD measurements * Use of hormone replacement therapy or other therapy that influence bone remodeling

Design outcomes

Primary

Measure	Time frame
Bone mass density	—

Countries

Norway

Outcome results

None listed

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