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

NCT00290212 | Completed Phase 2

• 1 other identifier: REK V 77/2005
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 2

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

Conditions

Perimenopausal Bone Loss

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bone mass density

Interventions

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

Placebo capsules DRUG

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Tromso: collaborator
• The International Osteoporosis Foundation: collaborator
• Haukeland University Hospital: collaborator

Study Sites (2)

Clinical Research Center, University Hospital of North Norway

Tromsø, Tromsø, N-9038, Norway

Location

Haukeland University Hospital

Bergen, NO 5021, Norway

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Soy Foods

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fermented Foods; Diet, Food, and Nutrition; Physiological Phenomena; Vegetable Products; Vegetables; Food; Food and Beverages

Study Officials

• Nina Emaus, MSc PhD

  NAFKAM, Fac.of Medicine, Univ. of Tromsø, Norway

  PRINCIPAL INVESTIGATOR

• Sameline Grimsgaard, MD, MPH, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

• Vinjar Fønnebø, MD, MSc, PhD

  NAFKAM, University of Tromsø, Norway

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 10, 2006
• Study Start: January 1, 2006
• Study Completion: June 1, 2007
• Last Updated: January 24, 2008

Record last verified: 2006-12

Locations

NO (2)