Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000763943
Ethics application status
Approved
Date submitted
21/07/2011
Date registered
21/07/2011
Date last updated
2/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bone Health,Vegetables,Herbs and Fruit Study
Scientific title
Fruit,Vegetables and Herbs, Post Menopausal Women and Bone Health
Secondary ID [1] 262675 0
Nil
Universal Trial Number (UTN)
U1111-1123-0770
Trial acronym
BHVHF study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone health in post menopausal women 268378 0
Inflammation and metabolic markers in post menopausal women 268379 0
Condition category
Condition code
Metabolic and Endocrine 268515 268515 0 0
Metabolic disorders
Musculoskeletal 268516 268516 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 267017 0
Lifestyle
Comparator / control treatment
Negative control group recruited separately consisting of post menopausal women with the same exclusion criteria as the intervention group.
This group to not share the same inclusion criteria as the intervention. They are the same in all respects except they do not choose to make the behaviour change to increase their intake of fruit and vegetables to 9 serves/day
Control group
Active

Outcomes
Primary outcome [1] 269262 0
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).
Timepoint [1] 269262 0
Change in bone markers at 3 months (after increasing fruit and vegetable intake and inclusion of selected herbs).
Secondary outcome [1] 279242 0
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
Timepoint [1] 279242 0
Inflammatory and metabolic markers at 3 months (after increasing fruit and vegetable intake and inclusion of selected herbs).

Eligibility
Key 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
Minimum age
50 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation was used in each of the 3 cities. A similar number of participants in each city was assigned to each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A negative control group has been recruited separately as this is a dietary and lifestyle intervention and we didnt want to rectruit women ready to make the behaviour change and then advise them not to.The 100 women in the intervention will be randomly allocated to two groups of 50 consuming differing veg,herbs and fruit.One group of the intervention will emphasise those foods (Fruit,veg and herbs) shown to be bone friendly in animals.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Parametric statistical analysis was done for normally distributed data otherwise non parametric tests (Kruskal-Wallis Test) were used (potassium urinary excretion) or logarithmic transformations were applied prior to one way analysis of variance analysis (ANOVA). Log transformed values were back transformed for tables. ANOVA was used to compare inflammatory, bone and urinary mineral excretion data. Post hoc tests (Scheffe and Tukey-B) were used to determine group difference as well as student t-tests for within group differences. Two way ANOVA was used to determine interaction effects between groups and BMD groups on bone markers using MANOVA with adjustments for multiple comparisons (Sidak).The number of subjects required in each group was calculated to be 32 (minimum). This was determined using a power calculation based on demonstrating a difference of ~8% in the primary outcome variable C-telopeptides of collagen (CTx) with 80% power and alpha of 0.05 (2 sided test) and accepting 0.4 micrmeters/ml as mean CTx of this population (Kruger, M.C, 2010). To detect any differences between the 2 diets and allowing for withdrawals, non-compliance or maintenance (~ 25%) approximately 50 women were needed in each group. Since there were 2 different diets emphasizing different vegetables and fruit and a control group who consumed their usual diet (= 5 servings F/V/day), three groups of 50 participants were required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2011
Actual
12/06/2011
Date of last participant enrolment
Anticipated
30/08/2011
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 3739 0
New Zealand
State/province [1] 3739 0
Palmerston North
Country [2] 3740 0
New Zealand
State/province [2] 3740 0
Auckland
Country [3] 3741 0
New Zealand
State/province [3] 3741 0
Hawkes Bay

Funding & Sponsors
Funding source category [1] 267496 0
Charities/Societies/Foundations
Name [1] 267496 0
Hawkes Bay Medical Research Foundation
Country [1] 267496 0
New Zealand
Primary sponsor type
Individual
Name
Professor Marlena Kruger
Address
Professor Marlena Kruger
IFNHH
Massey University
PO box 11 222
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 266540 0
Individual
Name [1] 266540 0
Associate Professor Welma Stonehouse
Address [1] 266540 0
Institute of Food, Nutrition and Human Health
Private Bag 102 904
North Shore City Post code 0745
Country [1] 266540 0
New Zealand
Other collaborator category [1] 252116 0
Individual
Name [1] 252116 0
Anne-Thea McGill FRNZCGP MBChB BSc
Address [1] 252116 0
Human Nutrition Unit, 18 Carrick Place, Mt Eden, Faculty of Medical and Health Sciences University of Auckland, Private Bag 92019
Auckland, New Zealand
Country [1] 252116 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269465 0
Massey University Human Ethics Committee: Southern A
Ethics committee address [1] 269465 0
Ethics committee country [1] 269465 0
New Zealand
Date submitted for ethics approval [1] 269465 0
Approval date [1] 269465 0
30/05/2011
Ethics approval number [1] 269465 0
11/11/2011

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32904 0
Prof Marlena Kruger
Address 32904 0
IFNHH Massey University POBox 11 222 Palmerston North 4442
Country 32904 0
New Zealand
Phone 32904 0
64 6 3569099 ext 5905
Fax 32904 0
Email 32904 0
[email protected]
Contact person for public queries
Name 16151 0
Caroline Gunn
Address 16151 0
IFNHH
Massey University
POBox 11 222
Palmerston North
4442
Country 16151 0
New Zealand
Phone 16151 0
64 6 3569099 ext 2311
Fax 16151 0
64 6 350 5657
Email 16151 0
[email protected]
Contact person for scientific queries
Name 7079 0
Professor Marlena kruger
Address 7079 0
IFNHH
Massey University
POBox 11 222
Palmerston North
4442
Country 7079 0
New Zealand
Phone 7079 0
64 6 3569099 ext 5905
Fax 7079 0
64 6 350 5657
Email 7079 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMidlife women, bone health, vegetables, herbs and fruit study. The Scarborough Fair study protocol.2013https://dx.doi.org/10.1186/1471-2458-13-23
EmbaseIncreased intake of selected vegetables, herbs and fruit may reduce bone turnover in post-menopausal women.2015https://dx.doi.org/10.3390/nu7042499
N.B. These documents automatically identified may not have been verified by the study sponsor.