The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000802303
Ethics application status
Approved
Date submitted
26/05/2017
Date registered
31/05/2017
Date last updated
2/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Bugs'n'Bones Study: The relationship between your diet, gut bacteria and bones
Scientific title
The relationship between dietary patterns, bone bio-markers, gut microbiome and bone density in menopausal women – A Cross-sectional Study
Secondary ID [1] 292046 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 303445 0
Condition category
Condition code
Diet and Nutrition 302853 302853 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 302909 302909 0 0
Menstruation and menopause
Musculoskeletal 302910 302910 0 0
Osteoporosis
Inflammatory and Immune System 306757 306757 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 306758 306758 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Phase 1 (150 participants)
3-day diet record self-administered individually in the participants' home once.
Food frequency questionnaire self-administered individually in the participants' home once.
Baseline participants' questionnaire self-administered individually face to face once.
New Zealand physical activity questionnaire administered individually face to face once.
DEXA and heel scan, anthropometric measurements. The phase 1 will go on for about 3 months.
Phase 2 (100 participants; 50 with osteoporosis and 50 without osteoporosis)
Blood sample for bone markers such as CTx and P1NP and urine sample for CTx-II and creatinine analysis as well as faecal sample for DNA extraction for microbial community analysis. The phase 2 will go on for about 4 weeks.
Intervention code [1] 298177 0
Not applicable
Comparator / control treatment
50 healthy women
Control group
Active

Outcomes
Primary outcome [1] 302252 0
Bone resorption by plasma CTX-1 assay
Timepoint [1] 302252 0
Baseline (phase 2)
Secondary outcome [1] 335300 0
Bone mineral density by DEXA
Timepoint [1] 335300 0
Baseline
Secondary outcome [2] 335301 0
Composite secondary outcome: Diversity and density of gut microbiome by 16S v3v4 metagenomics assessed from faecal samples
Timepoint [2] 335301 0
Baseline (phase 2)
Secondary outcome [3] 335302 0
Inflammation rate by inflammatory markers (CRP, ESR, IL-1, IL-6 and IL-10) from serum samples
Timepoint [3] 335302 0
Baseline (phase 2)
Secondary outcome [4] 335434 0
Dietary intake by 3-day diet diary and food frequency questionnaire validated in the School of Food & Nutrition, Massey University
Timepoint [4] 335434 0
baseline
Secondary outcome [5] 335435 0
Physical activity level by New Zealand Physical Activity Questionnaire validated in New Zealand
Timepoint [5] 335435 0
At baseline

Eligibility
Key inclusion criteria
Confirmed menopause of at least 5 years based on no menstruation.
Body Mass Index (BMI) between 17 and 30kg/m2 .
Minimum age
55 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Incidence of medically diagnosed diabetes mellitus by the baseline screening
2. Presence of any systemic disease or endocrine disease such as vasculitis, pheochromocytoma
3. Any significant weight loss or weight gain within the past year (i.e. 5% of your body weight)
4. Food intolerances which cause gastrointestinal symptoms (i.e. lactose intolerance)
5. Smoker
6. High intake of alcohol (more than 2 standard drinks a day)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Sample size was calculated using G*Power and a total of 88 subjects was required for a 90% power and an alpha of 5% for the T test.
Based on the known prevalence of osteoporosis, a total of 150 women aged 55 to 70 years (for phase 1) will be sought after. Amongst these women, 100 women (allowing for 10% dropout) would be selected based on their bone health status. We will therefore have 50 women with poor bone health and 50 healthy women which will be enrolled for Phase 2.

Statistical analyses will be carried out using SAS statistical software. The Schofield equation will be used to calculate the metabolic rate. The ratio of energy intake (EI) to basal metabolic rate (BMR) will be used to evaluate relative accuracy of reported energy intake using the Goldberg cut-off. The ratio EI:BMR as defined by WHO/FAO/UNU:- 1.27 for minimum survival level, 1.56 for sedentary level and 2.0-2.4 for maximum sustainable lifestyle level will be used to compare the degree of underreporting and overreporting in the subjects.
Factor analysis will be used to derive dietary patterns which will be based on the weight of food consumed in grams (summing of intakes) by factor loadings using the principal component analysis method and orthogonal transformation (varimax rotation) from the food intake data (3-day diet record and FFQ) to facilitate interpretability. A criteria of eigenvalues will be used for the factor analysis.
Factors will be divided into quintiles; sample means and frequencies will be calculated. Any association will be adjusted for age, height, smoking, physical activity, education and energy intake. Any correlations with the dependent variables will be calculated using partial correlation coefficients. A P value of < 0.05 will be considered as significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Safety concerns
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8920 0
New Zealand
State/province [1] 8920 0
Manawatu-Wanganui region

Funding & Sponsors
Funding source category [1] 296578 0
University
Name [1] 296578 0
Massey University
Address [1] 296578 0
School of Food and Nutrition
Massey University
Private Bag 11222
Palmerston North 4442
Country [1] 296578 0
New Zealand
Primary sponsor type
University
Name
massey university
Address
School of Food and Nutrition
Massey University
Private Bag 11222
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 295534 0
None
Name [1] 295534 0
Address [1] 295534 0
Country [1] 295534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297803 0
Massey University Human Ethics Committee: Southern A, Application 17/17
Ethics committee address [1] 297803 0
Chairperson
Research Centre for Maori Health & Development
Massey University
Private Bag 11222
Palmerston North 4442
New Zealand
Ethics committee country [1] 297803 0
New Zealand
Date submitted for ethics approval [1] 297803 0
24/03/2017
Approval date [1] 297803 0
24/05/2017
Ethics approval number [1] 297803 0
4000017287

Summary
Brief summary
Osteoporosis is a health problem in the elderly with hip and spine fractures occurring commonly after the age of 70. Low bone mineral density (BMD) is a risk factor for osteoporosis, with early detection allowing precautionary measures. There are many modifiable factors that increase the risk of osteoporosis and fractures including diet, physical activity, hormones, alcohol intake, smoking and body weight.

The primary purpose of the study is
1. To determine the pattern of diet of women in the age group between 55-70 years.
2. To assess the relationship between patterns of diet and diverse gut microbiome in this group of female volunteers with or without low bone mass.
3. To determine the diversity and density of the gut community.
4. To evaluate the relationship between patterns of diet and rate of inflammation.

Study hypothesis
1. Individuals with characteristic dietary patterns will be associated with similar/particular gut bacteria, for example, high fat (high LDL-c) and sugar dietary patterns.
2. The regular consumption of certain diets, for example, Mediterranean-style diets will indicate a desirable bone health status in this age group.
3. Individuals identified as having high fat and sugary diets will have an increased inflammation compared to a high fibre dietary pattern.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75138 0
Mrs Bolaji Lilian Ilesanmi-Oyelere
Address 75138 0
School of Food and Nutrition
Massey University
Private Bag 11222
Palmerston North 4442
Country 75138 0
New Zealand
Phone 75138 0
+64 2108522308
Fax 75138 0
Email 75138 0
b.ilesanmi-oyelere@massey.ac.nz
Contact person for public queries
Name 75139 0
Mrs Bolaji Lilian Ilesanmi-Oyelere
Address 75139 0
School of Food and Nutrition
Massey University
Private Bag 11222
Palmerston North 4442
Country 75139 0
New Zealand
Phone 75139 0
+64 2108522308
Fax 75139 0
Email 75139 0
b.ilesanmi-oyelere@massey.ac.nz
Contact person for scientific queries
Name 75140 0
Prof Marlena Kruger
Address 75140 0
School of Food and Nutrition
Massey University
Private Bag 11222
Palmerston North 4442
Country 75140 0
New Zealand
Phone 75140 0
+ 64 6 9517571
Fax 75140 0
Email 75140 0
m.c.kruger@massey.ac.nz

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary