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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001001785

Enrollment

Registered

2013-09-10

Start date

2013-09-02

Completion date

2013-12-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 c

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

50 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy post-menopausal women aged between 50-65 will be recruited.

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.

Outcome results