CompletedPhase 2ACTRN12611000763943

Bone Health,Vegetables,Herbs and Fruit Study

Fruit,Vegetables and Herbs, Post Menopausal Women and Bone Health


Sponsor

Professor Marlena Kruger

Enrollment

150 participants

Start Date

Jun 12, 2011

Study Type

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

Sex: FemalesMin Age: 50 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at whether increasing fruit and vegetable intake to 9 servings per day can improve bone health in postmenopausal women aged 50-70. Participants will follow a high fruit and vegetable diet, and researchers will measure changes in bone density and related markers over time.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Palmerston North, New Zealand

Auckland, New Zealand

Hawkes Bay, New Zealand

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ACTRN12611000763943