Bugs'n'Bones Study: The relationship between your diet, gut bacteria and bones

The relationship between dietary patterns, bone bio-markers, gut microbiome and bone density in menopausal women – A Cross-sectional Study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12617000802303

Enrollment

127

Registered

2017-05-31

Start date

2017-06-08

Completion date

2017-12-07

Last updated

2018-06-11

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

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

55 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Confirmed menopause of at least 5 years based on no menstruation. Body Mass Index (BMI) between 17 and 30kg/m2 .

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)

Outcome results