Bone Health,Vegetables,Herbs and Fruit Study

Phase 1

Completed

• Conditions: Bone health in post menopausal women; Inflammation and metabolic markers in post menopausal women; Metabolic and Endocrine - Metabolic disorders; Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12611000763943
• Lead Sponsor: Professor Marlena Kruger

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Healthy, post menopausal women between the age of 50-70 years who haven’t had a period for 5 years willing to increase their intake of fruit and vegetables to 9 serves/day. Target population for the negative control group Diet and Metabolic Markers in Healthy NZ women (DMM) women in the same category as above who will be required to make no changes to diet or lifestyle

Exclusion Criteria

Post menopausal women having had a hysterectomy. Those with osteoporosis previously diagnosed or who have osteoporosis diagnosed as result of screening for this study. Those with both hips replaced. Those with previous fractures of the lower vertebra or hip, those who have severe osteoarthritis* of the lower spine or hips. History of gastrointestinal, liver or renal disease. Currently on medication for diabetes, heart disease, osteoporosis (including HRT) or any medication that may affect bone or calcium metabolism (oral corticosteroids, warfarin, dilantin. potassium sparing diuretics). Any severe diseases including treatment for cancer within the last 3 years. Smokers, alcohol consumption greater than 20 standard drinks/week).Women already consuming more than 6 standard serves fruit and vegetables every day. Those taking calcium supplements and unwilling to stop a month before the study and for the duration of the study. Those unable to consume 2 serves/dairy or soy (with calcium) or alternative every day. Those participants who develop an illness during the study that requires treatment with steroids or medication that affects bone, inflammatory and other metabolic markers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints are the change in measurements with bone turnover markers, specifically bone resorption marker serum C-telopeptide of type 1 collagen (CTx) and bone formation markers procollagen 1 N-terminal peptide (P1NP).[Change in bone markers at 3 months (after increasing fruit and vegetable intake and inclusion of selected herbs).]

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes are the changes in pro and anti-inflammatory markers. adiponectin, c reactive protein (CRP), interleukin 6 (IL-6), tumour necrosis factor (TNF-alpha) Metabolic markers triglycerides, cholesterol HDL, LDL and fibrinogen and PAI-1 [Inflammatory and metabolic markers at 3 months (after increasing fruit and vegetable intake and inclusion of selected herbs).]