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Dr Edward Chambers
e.chambers@imperial.ac.uk


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Be Part of Research - Trial Details - Gut microbial activity, lifestyle factors, and bone metabolism in premenopausal and postmenopausal women
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Gut microbial activity, lifestyle factors, and bone metabolism in premenopausal and postmenopausal women

Recruiting

Open to: Female

Age: Mixed

London

Medical Conditions

Osteoporosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Short-chain fatty acids (SCFAs) are generally considered beneficial because they help lower inflammation, support gut barrier integrity, and may contribute to bone health by influencing bone turnover (the rate of bone formation and breakdown). Lower or disrupted SCFA production has been linked to higher inflammation and poorer metabolic health. Measuring SCFAs in this study will help us understand whether differences in SCFA levels play a role in bone health changes before and after menopause.
As women transition from pre- to post-menopause, significant changes occur in hormone levels, metabolism, and gut health. These changes may impact the production of SCFAs, compounds produced by gut bacteria that play an important role in bone turnover markers, inflammation control, and overall health.
This study aims to assess how menopausal ageing and lifestyle factors such as dietary fibre intake and physical activity influence SCFAs, bone turnover markers, and gut health markers. It will compare SCFA levels and bone turnover markers between premenopausal women (aged 18–40 years) and postmenopausal women (≥5 years post-menopause) aged 60 years and older. This research will provide insights into lifestyle strategies to support metabolic and skeletal health in ageing women.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Mar 2026 28 Feb 2027

If you do decide to participate, the study will consist of two separate study visits. We request that you do not start any new diets or intensive exercise regimes (dramatically increase the amount of exercise you do, for example, join a gym) in between the study visits, as this may give us conflicting results.

Visit 1 – Health Screening:
You will be asked to attend the NIHR Imperial Clinical Research Facility at Hammersmith Hospital, where you will be interviewed about your general health. You will have a blood test to confirm that you are non-diabetic, and your body weight and height will be recorded. Women of childbearing potential will complete a urinary pregnancy test. The duration of the study visit would be around 1 hour.

After confirming eligibility, you will receive:
1. A 7-day wearable physical activity monitor. The device is waterproof, and you will be asked to wear this on your wrist continuously for 7 days.
2. Access to an online food diary (https://intake24.org/) to track dietary intake for 7 days
3. A stool and urine sample kit for home collection. Detailed instructions on collection and storage will be provided.

Visit 2 – Study Assessment:
This visit will take place after your 7-day monitoring period. You will return your stool and urine samples, and we will collect a blood sample. This blood sample will be used to analyse several markers related to bone and gut health, such as:
1. CTX (C-terminal telopeptide): a marker of bone resorption, which is the process of old bone being broken down.
2. PINP (procollagen type 1 N-terminal propeptide): a marker of new bone formation.
3. Osteocalcin: a marker of new bone formation.
4. PTH (parathyroid hormone): a hormone that helps regulate calcium levels.
5. Vitamin D: important for bone strength and calcium absorption.
6. LPS (lipopolysaccharide): a component of bacteria in the gut. Higher levels in blood are used as a marker of intestinal permeability, i.e., a leaky gut.
Your urine sample will be used to measure NTX (N-terminal telopeptide): a marker of bone resorption.
Your stool sample will be used to measure levels of SCFA and intestinal permeability markers (calprotectin and zonulin).
Stool calprotectin and zonulin are biomarkers related to gut health, where LPS can indicate a leaky gut, calprotectin is a marker of intestinal inflammation, and zonulin is a marker of intestinal permeability.


1. Premenopausal women aged 18–40 years
2. Postmenopausal women (≥5 years post-menopause) aged ≥60 years
3. BMI between 18.5 and 30 kg/m²
3. HbA1c <48 mmol/mol

You can take part if:



You may not be able to take part if:


1. Non-English speakers2. Individuals with chronic diseases that affect the gut microbiome, metabolic health or bone metabolism (e.g. type 1 or 2 diabetes, bowel diseases such as Crohn’s disease or irritable bowel syndrome, osteoporosis, etc)3. HbA1c ≥48 mmol/mol4. Individuals with a BMI less than 18.5 kg/m² (underweight) or greater than 30 kg/m² (obesity)5. Medications and dietary supplements in the last 3 months that would impact trial outcomes:5.1. Antibiotics5.2. Proton Pump Inhibitors (PPIs)5.3. Laxatives & Antidiarrheals5.4. Immunosuppressants5.5. Metformin5.6. Nonsteroidal anti-inflammatory drugs5.7. Bisphosphonates5.8. Estrogen and/or progesterone (Hormone replacement therapy (HRT)) 5.9. Denosumab5.10. Anabolic steroids5.11. Teriparatide5.12. Thyroid medication5.13. Dietary fibre, prebiotic or probiotic supplements6. Known congenital or acquired bone disease other than osteopenia (including osteomalacia, hyperparathyroidism, Paget’s disease)7. History of major psychiatric illness8. Drink more than 14 units of alcohol per week on a regular basis9. Consumption of recreational drugs10. Current smokers (daily)11. Pregnancy12. Not involved in other research projects in the previous 12 weeks


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • NIHR Imperial Clinical Research Facility
    Hammersmith Hospital Du Cane Rd Shepherd's Bush
    London
    W12 0HS

There is no guarantee that you will experience a clinical benefit from taking part in the study. Some of the procedures in this study, such as the recording of your weight, height and blood pressure present no risk to you. Other procedures, such as taking blood samples, can cause mild discomfort. The risks of taking a blood sample include slight discomfort when the needle is inserted and possible bruising and a localised infection. These procedures will only be carried out by experienced doctors under aseptic conditions to minimise all these risks.

Dr Edward Chambers
e.chambers@imperial.ac.uk



The study is sponsored by Imperial College London and funded by Saudi Arabian Cultural Bureau.



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Read full details for Trial ID: ISRCTN17635288
Last updated 29 May 2026

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