Authors
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Professor Marlena Kruger -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2011
INTERVENTION: 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. CONDITION: Bone health in post menopausal women Inflammation and metabolic markers in post menopausal women PRIMARY OUTCOME: 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). SECONDARY OUTCOME: 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 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
Epistemonikos ID: 1a541005f5ea3c0f537b34f81a6b5c8a1b98147a
First added on: Aug 25, 2024