Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001001785
Ethics application status
Approved
Date submitted
6/09/2013
Date registered
10/09/2013
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of soy isoflavones and kiwifruit on bone turnover, hormone levels, blood lipids and faecal microflora in menopausal women.

Scientific title
The effect of soy isoflavones in combination with green kiwifruit on bone turnover, hormone levels, blood lipids and faecal microflora in menopausal women.

Secondary ID [1] 283151 0
None
Universal Trial Number (UTN)
U1111-1147-6503
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 290010 0
Blood lipids 290011 0
Condition category
Condition code
Musculoskeletal 290395 290395 0 0
Osteoporosis
Metabolic and Endocrine 290415 290415 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a cross over study. There are two interventions. One with 40mg Soy isoflavones in two tablets/day only and the other with 40mg soy isoflavones plus 2 kiwifruit per day. The intervention is for 2 periods of 6 weeks. There is one washout period of 2 weeks before the start of the trial; one arm starting on the soy isoflavones tablets only and the other arm with kiwifruit in combination with the soy isoflavones. After 6 weeks there is a second washout period of 2 weeks before the two arms cross over. The supplementation is for another 6 weeks. Adherence will be recorded in a diary.
Intervention code [1] 287888 0
Other interventions
Comparator / control treatment
The isoflavones only group is the comparator.
Control group
Active

Outcomes
Primary outcome [1] 290415 0
Bone markers urinary deoxypyridinoline, plasma C-telopeptide of Type I collagen, and serum undercarboxylated osteocalcin.
Timepoint [1] 290415 0
baseline and six weeks
Primary outcome [2] 290416 0
Blood and urine daidzein, genistein and equol
Timepoint [2] 290416 0
Baseline and week 6
Secondary outcome [1] 304473 0
Blood lipids
Timepoint [1] 304473 0
Baseline and week 6
Secondary outcome [2] 304474 0
Blood estradiol
Timepoint [2] 304474 0
Baseline and week 6
Secondary outcome [3] 304523 0
Faecal microflora
Timepoint [3] 304523 0
Baseline and week 6 after kiwifruit consumption only.

Eligibility
Key inclusion criteria
Healthy post-menopausal women aged between 50-65 will be recruited.
Minimum age
50 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are as follows: osteoporosis at the hip or spine; history of chronic renal or hepatic disease, history of hormone therapy use or breast cancer, soy allergies, and use of any other medication known to affect the skeleton or antibiotics that will affect gut microflora.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Excel spread sheet
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation for bone marker analysis:

Serum CTx (cross linked C- telopeptide of type 1 collagen): 20 subjects per group
The sample size calculation showed that with 20 subjects in each group, a difference of 0.09 ng/ml between the means of serum CTx concentration could be shown with a power of 0.80 and a two-side type 1 error of 0.05.

Serum ucOC (under carboxylated osteocalcin): 25 subjects per group
The sample size calculation showed that with 25 subjects in each group, a difference of 1.35 ng/ml between the means of serum ucOC concentration could be shown with a power of 0.80 and a two-side type 1 error of 0.05.

Urinary DPD (Deoxypyridinoline): 27 subjects per group
The sample size calculation showed that with 27 subjects in each group, a difference of 1.79 nM/mM Cr between the means of urinary DPD concentration could be shown with a power of 0.80 and a two-side type 1 error of 0.05.

Analysis will be with repeated measures ANOVA; 2 way ANOVA. Results of the bone markers, lipids and hormones will be expressed as % change from baseline.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/09/2013
Actual
2/09/2013
Date of last participant enrolment
Anticipated
10/09/2013
Actual
20/12/2013
Date of last data collection
Anticipated
Actual
30/05/2014
Sample size
Target
40
Accrual to date
Final
33
Recruitment outside Australia
Country [1] 5393 0
New Zealand
State/province [1] 5393 0

Funding & Sponsors
Funding source category [1] 287906 0
Government body
Name [1] 287906 0
Ministry of Business, Innovation and Employment
Country [1] 287906 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zespri International
Address
400 Maunganui Road, Mount Maunganui, 3116, New Zealand.
Country
New Zealand
Secondary sponsor category [1] 286634 0
None
Name [1] 286634 0
Address [1] 286634 0
Country [1] 286634 0
Other collaborator category [1] 277606 0
Individual
Name [1] 277606 0
Dr Y Ishimi
Address [1] 277606 0
National Institute of Health and Nutrition, 1-23-1 Toyama, Shinjuku-ku, 162-8636, Tokyo, Japan.
Country [1] 277606 0
Japan
Other collaborator category [2] 277607 0
Individual
Name [2] 277607 0
Dr Y Tousen
Address [2] 277607 0
National Institute of Health and Nutrition, 1-23-1 Toyama, Shinjuku-ku, 162-8636, Tokyo, Japan.
Country [2] 277607 0
Japan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289843 0
Southern A
Ethics committee address [1] 289843 0
Massey University, Private Bag 11222, Palmerston North 4442
Ethics committee country [1] 289843 0
New Zealand
Date submitted for ethics approval [1] 289843 0
25/06/2013
Approval date [1] 289843 0
07/08/2013
Ethics approval number [1] 289843 0

Summary
Brief summary
The purpose of this study is to evaluate the effects of soybean isoflavones in combination with kiwifruit on equol production and bone health in menopausal women. We hypothesize that the kiwifruit will affect gut microflora and the metabolism of the soy isoflavones.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 42714 0
Prof Marlena Kruger
Address 42714 0
Institute of Food, Nutrition and Human Health, Massey University, Private Bag 11222, Palmerston North 4442
Country 42714 0
New Zealand
Phone 42714 0
+6463505905
Fax 42714 0
+6463505446
Email 42714 0
[email protected]
Contact person for public queries
Name 42715 0
Prof Marlena Kruger
Address 42715 0
Institute of Food, Nutrition and Human Health, Massey University, Private Bag 11222, Palmerston North 4442
Country 42715 0
New Zealand
Phone 42715 0
+6463505905
Fax 42715 0
Email 42715 0
[email protected]
Contact person for scientific queries
Name 42716 0
Prof Marlena Kruger
Address 42716 0
Institute of Food, Nutrition and Human Health, Massey University, Private Bag 11222, Palmerston North, 4442
Country 42716 0
New Zealand
Phone 42716 0
+6463505905
Fax 42716 0
Email 42716 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
No additional documents have been identified.