Influence of soluble corn fibre on markers of immunity and inflammation
| ISRCTN | ISRCTN15979195 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15979195 |
| IRAS number | 317212 |
| Secondary identifying numbers | 76736, IRAS 317212, CPMS 55174 |
- Submission date
- 15/02/2023
- Registration date
- 17/02/2023
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
As people age their immune systems can become weaker and there is often an increase in inflammation which contributes to common age-related diseases. These include heart disease, metabolic disease such as type-2 diabetes, the loss of muscle mass and strength known as sarcopenia, the weakening of bones known as osteoporosis, some cancers, and possibly dementia. A weaker immune system means older people can be more susceptible to infections and some vaccines may not work as well as in younger adults. The “healthy” bacteria in the intestine (called gut microbiota) have an influence on the immune system and inflammation. Interestingly, intestinal bacteria also change with ageing and this can result in the loss of protective function and in the movement of harmful bacterial toxins and whole bacteria from the gut into the blood. Why these changes occur and how we can improve this in ageing are not understood. What we do know is that intestinal bacteria can be altered by diet. Fibre intake is considered essential for optimal gut health including maintaining healthy gut bacteria. However, most people do not eat enough fibre. We plan to investigate whether fibre supplements improve measures of the immune system, inflammation and intestinal bacteria in men and women aged over 60 years. The fibre we will use is called soluble corn fibre. This resists digestion and absorption in the small intestine and passes to the large intestine where it can be used by the gut microbiota. Soluble corn fibre has been shown to beneficially modify gut microbiota but its effects on the immune system and inflammation have not been tested. We plan to compare the effects of soluble corn fibre on the immune system and inflammation and gut microbiota with the effects of a placebo which is a poorly digested sugar called maltodextrin.
Who can participate?
Healthy men and women over the age of 60 years old
What does the study involve?
The study involves making two visits to the Clinical Research Facility at University Hospital Southampton. Each visit will last about 1.5 hours. In between visits participants will be randomly allocated to consume supplements of either placebo (maltodextrin) or soluble corn fibre each day for 12 weeks. At each clinic visit participants will be asked questions about their diet. They will provide a blood sample for the measurement of immune and inflammatory markers. They will also provide a urine and faecal sample at the start and end of the study. In between visits, participants will be asked to keep a daily log to record the ingestion of their supplements.
What are the possible benefits and risks of participating?
Participants may benefit from positive effects on their immune system and//or their intestinal bacteria. Knowledge gained from the study will help research and will ultimately be of use to other researchers, industries and consumers. With any procedure involving blood collection with a needle, there is a very small chance of infection and a chance of bleeding and bruising at the site of insertion of the needle. This will be minimised by using sterile techniques and trained members of the staff.
Where is the study run from?
The University of Southampton (UK)
When is the study starting and how long is it expected to run for?
January 2021 to June 2025
Who is funding the study?
Tate & Lyle Plc (UK)
Who is the main contact?
Prof Philip Calder, pcc@soton.ac.uk (UK)
Contact information
Principal Investigator
School of Human Development and Health
Faculty of Medicine
University of Southampton
IDS Building
MP887 Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
 ORCID ID |
0000-0002-6038-710X |
|---|---|
| Phone | +44 (0)2381205250 |
| pcc@soton.ac.uk |
Scientific
School of Human Development and Health
Faculty of Medicine
University of Southampton
IDS Building
MP887 Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44(0)2381205250 |
|---|---|
| pcc@soton.ac.uk |
Public
School of Human Development and Health
Faculty of Medicine
University of Southampton
IDS Building
MP887 Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44(0)2381205250 |
|---|---|
| pcc@soton.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Pharmaceutical testing facility |
| Study type | Prevention |
| Participant information sheet | 43227_PIS_v4.0_03Feb2023.pdf |
| Scientific title | Soluble corn fibre and markers of immunity and inflammation in older adults: a randomised controlled trial |
| Study hypothesis | The objective of this study is to identify the effects of soluble corn fibre, in the form of PROMITOR®, a Tate & Lyle product used in the food industry, on markers of immunity and inflammation and on faecal microbiota in older adults. |
| Ethics approval(s) | Approved 28/12/2022, South Central - Hampshire A Research Ethics Committee (Temple Quay House, 2 The Square, Temple Quay, Bristol BS1 6PN, UK; +44 (0)207 104 8196; hampshirea.rec@hra.nhs.uk), ref: 22/SC/0414 |
| Condition | People aged 60 + years living in the community |
| Intervention | Participants will be sought through poster advertisements; articles in the media (newsletters, newspapers, radio, and university project-specific social media pages); posters and email within the University of Southampton and University Hospital Southampton NHS Foundation Trust; and by contacting those on a GDPR compliant database held by the University Hospital Southampton. The study involves making two visits to the Clinical Research Facility at University Hospital Southampton, one at study entry and the second 12 weeks later. Each visit will last about 1.5 hours. Participants will be randomly allocated IDs according to a random number generator for a two-arm study to two treatment groups to consume control (maltodextrin 2 g/day - calorie matched to soluble corn fibre) and soluble corn fibre (20 g/day) for 12 weeks in between study visits. At each clinic visit participants will be asked questions about their diet. They will provide a blood sample for the measurement of immune and inflammatory markers. They will also provide a urine and faecal sample at the start and end of the study. In between visits, participants will be asked to keep a daily log to record the ingestion of their supplements. |
| Intervention type | Supplement |
| Primary outcome measure | Blood neutrophil phagocytosis of E. coli measured as median fluorescence intensity using flow cytometry, reflecting the number of bacteria taken up per neutrophil, at study entry and exit (week 12) |
| Secondary outcome measures | All secondary outcomes are assessed at study entry and exit (12 weeks) 1. Blood immune cell phenotypes (number of each cell type per microlitre of blood) measured by flow cytometry 2. Plasma inflammatory cytokines and chemokines (mg/l) measured by multiplex immunoassay 3. Plasma C-reactive protein (mg/l) measured by immunoassay 4. Blood monocyte phagocytosis of E. coli measured as median fluorescence intensity by flow cytometry 5. Blood natural killer cell activity measured as % killing to K562 target cells by flow cytometry 6. Blood T cell response to stimulation with Con A measured as CD69 expression (flow cytometry) and immunoregulatory cytokine production (multiplex immunoassay) 7. Blood monocyte response to stimulation with LPS measured as immunoregulatory cytokine production (multiplex immunoassay) 8. Faecal microbiota measured as the numbers of different organisms/g faeces by 16S RNA sequencing 9. Faecal short-chain fatty acid concentrations (mmol/l) measured by gas chromatography 10 Faecal calprotectin and intestinal fatty acid binding protein (mg/l) measured by immunoassay 11. Plasma short-chain fatty acids (mmol/l) measured by gas chromatography 12. Urinary metabolome measured by nuclear magnetic resonance 13. Gastrointestinal health measured by questionnaire and Bristol Stool Chart score 14. Energy (cal/day) and macronutrient (g/day) intake measured by a food frequency questionnaire (FFQ) |
| Overall study start date | 20/01/2021 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 72 |
| Participant inclusion criteria | 1. Community-dwelling males and females aged 60 years and older 2. Body mass index of 18.5-30 kg/m2 3. Have regular bowel movements 4. Willing to adhere to the study protocol 5. Able to provide written informed consent |
| Participant exclusion criteria | 1. Living in a care or nursing home 2. Diagnosed with diabetes or other metabolic and endocrine disorders 3. Presence of active gastrointestinal disease (coeliac disease, Crohn’s disease, diagnosed IBD etc.), autoimmune disease, or inflammatory disease (lupus, rheumatoid arthritis, multiple sclerosis) 4. Use of prescribed medicine to control inflammation (e.g. non-steroidal anti-inflammatory drugs; NSAIDs) or regular use of over-the-counter NSAIDs 5. Use of dietary supplements (will allow a 4-week washout period) 6. Use of probiotic drinks or yoghurts (will allow a 4-week washout period) 7. Have extreme habitual fibre intake (lower than 10 g per day or higher than 30 g per day) based on a validated fibre screening tool 8. Blood donation in the previous 3 months. 9. Participation in any other clinical trial in the previous 3 months |
| Recruitment start date | 01/03/2023 |
| Recruitment end date | 31/12/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
IDS Building
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
University/education
University Road
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44(0)2380595058 |
|---|---|
| rgoinfo@soton.ac.uk | |
| Website | https://www.southampton.ac.uk |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in high impact peer reviewed journals |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 4.0 | 03/02/2023 | 17/02/2023 | No | Yes |
| Protocol file | version 3.0 | 10/02/2023 | 17/02/2023 | No | No |
| HRA research summary | 20/09/2023 | No | No |
Additional files
Editorial Notes
21/01/2025: The following changes were made to the study record:
1. The overall study end date was changed from 31/01/2025 to 30/06/2025.
2. The intention to publish date was changed from 21/06/2025 to 31/12/2025.
03/04/2024: The following changes were made to the study record:
1. Total final enrolment added.
2. The overall study end date was changed from 31/03/2024 to 31/01/2025.
3. The intention to publish date was changed from 31/12/2024 to 21/06/2025.
11/12/2023: The recruitment end date was changed from 30/11/2023 to 31/12/2023.
16/10/2023: The recruitment end date was changed from 01/10/2023 to 30/11/2023.
20/09/2023: A link to the HRA research summary was added.
31/08/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 01/07/2023 to 01/10/2023.
2. The overall study end date was changed from 31/08/2023 to 31/03/2024.
01/03/2023: Internal review.
17/02/2023: Trial's existence confirmed by Health Research Authority (UK).
