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

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

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