Bone Health,Vegetables,Herbs and Fruit Study
Fruit,Vegetables and Herbs, Post Menopausal Women and Bone Health
Professor Marlena Kruger
150 participants
Jun 12, 2011
Interventional
Conditions
Summary
Bone health and fruit and vegetable intake are positively linked. This has been attributed to the varying micronutrients, phytochemicals and/or alkali precursors which reduce potential renal acid load (PRAL).Animal studies demonstrate specific vegetables, fruit and herbs possess bone resorption inhibiting properties (BRIP). Very few human intervention studies have been done with post menopausal women using a food specific approach to significantly reduce dietary PRAL and no study has included these specific vegetables, fruit and herbs to determine change in bone turnover and inflammatory markers, though several animal studies have shown beneficial effects on markers and bone density. This intervention study (Bone Health, Vegetables, Herbs and Fruit) involves changing the fruit and vegetables intake of 100 women from less than or equal to 5 to 9 or more serves /day for 3 months. Another group called “Diet and Metabolic Markers in Healthy Post Menopausal Women” or DMM group will involve an additional 50 women. This group will be run concurrently and serve as a negative control group. Using a randomized parallel controlled design the women in the dietary intervention will be assigned to one of the two arms involved in increasing fruit and vegetable intake and including selected herbs. One arm, will be advised to consume a high fruit and vegetable diet (Diet IA) of 9 serves/day (low PRAL, general range of vegetables, fruit and herbs but avoiding those with BRIPs), The second arm will also consume 9 serves/day but of the 9 serves, 4-5 serves will be selected from a range of BRIP vegetables, fruit and culinary herbs i.e. Diet IB (low PRAL including specific BRIP vegetables, fruit and culinary herbs). The negative control group C (DMM) will continue with their normal diet and receive no intervention. We will monitor for changes in bone resorption and formation markers (serum C-telopeptide of type 1 collagen (CTX) and procollagen 1 N-terminal peptide (P1NP), insulin-like growth factor (IGF-1) and Parathyroid Hormone. We will also monitor changes in anti-inflammatory markers; adiponectin, c reactive protein (CRP), interleukin 6 (IL-6), nuclear factor kappa binding (NF kappa B) and tumour necrosis factor (TNF-alpha) as well as metabolic markers; triglycerides, cholesterol, LDL, HDL, fibrinogen and PAI-1.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
Fruit,Vegetables and Herbs This intervention study (Bone Health, Vegetables, Herbs and Fruit) involves changing the fruit and vegetables intake of 100 women from less than or equal to 5 to 9 or more serves /day for 3 months. Another group called “Diet and Metabolic Markers in Healthy Post Menopausal Women” or DMM group will involve an additional 50 women. This group will be run concurrently and serve as a negative control group. Using a randomized parallel controlled design the women in the dietary intervention will be assigned to one of the two arms involved in increasing fruit and vegetable intake and including selected herbs. One arm, will be advised to consume a high fruit and vegetable diet (Diet IA) of 9 serves/day (low PRAL, general range of vegetables, fruit and herbs but avoiding those with Bone resorption inhibiting properties BRIPs), The second arm will also consume 9 serves/day but of the 9 serves, 4-5 serves will be selected from a range of BRIP vegetables, fruit and culinary herbs i.e. Diet IB (low PRAL including specific BRIP vegetables, fruit and culinary herbs). Brip vegetables include those from the cruciferous and allium family,fruits include citrus and herbs include those common culinary green herbs in culinary quantities only (.25tsp) such as sage. The negative control group C (DMM) will continue with their normal diet and receive no intervention. We will monitor for changes in bone resorption and formation markers (serum C-telopeptide of type 1 collagen (CTX) and procollagen 1 N-terminal peptide (P1NP), insulin-like growth factor (IGF-1) and Parathyroid Hormone. We will also monitor changes in anti-inflammatory markers; adiponectin, c reactive protein (CRP), interleukin 6 (IL-6), nuclear factor kappa binding (NF kappaB) and tumour necrosis factor (TNF-alpha) as well as metabolic markers; triglycerides, cholesterol, LDL, HDL, fibrinogen and PAI-1.
Locations(3)
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ACTRN12611000763943