Understanding the Benefits of Dietary Fibre Supplementation in Patients With Prostate Cancer

NCT06661044 | Completed

• 2 other identifiers: 2-054-24556
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The digestive tract (large intestine) contains microorganisms that digest complex carbohydrates in food to produce chemical substances which are beneficial to human health. The population of these microorganisms in faeces (stool samples) could be used to diagnose the health status of a person and this can be changed with the use of antibiotics, diet, radiotherapy or infection. Dietary fibre supplements can help provide nutrients for the beneficial bacteria from the large intestine to produce useful chemicals that may delay growth or even shrink prostate cancer in patients. The investigators will feed mice diets containing several dietary fibres (including inulin, pectin and hemp hull) and also faeces from healthy male human volunteers over 60 years old to see what effect this has on the makeup of the bacteria in their gut and the resulting beneficial metabolites (chemicals). For this work, the research team need to obtain four to six fresh faecal samples on the same day, so that these can be mixed fresh and stored for use as faecal microbiota transplant (FMT) in the mice. The researchers will then test how altering the gut microorganisms with faeces and dietary fibre supplements can influence the growth of prostate cancer cell tumours in mice. The investigators expect to see an effect of the fibres in promoting beneficial bacteria and in shrinking the tumours. This work will allow the investigators to identify dietary fibres that could be used in nutritional therapies for management of prostate cancer patients in future.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

Prostate cancer; Dietary fibre; Faecal microbiota transplant; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 16S rRNA gene sequencing

  The investigators will extract bacterial DNA for 16S rRNA gene sequencing analysis to compare the baseline microbial community of volunteers to that of the mice microbiota after faecal microbiota transplantation.

  December 2024 to October 2025

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: This study is interested in looking at prostate cancer and accepts only biological male volunteers.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will also invite men over 60 years who are staff at the University of Aberdeen, via All Staff mailing lists (including SMMSN and Rowett) and the University's weekly News Update and small ads.

You may qualify if:

• Men (biologically male) over 60 years old.
• Regularly pass a bowel motion at least daily.
• Able to attend the Rowett Institute for consent procedure and able to arrange delivery of fresh faecal sample to the Rowett Institute on the required study day.

You may not qualify if:

• Living with cancer/on active cancer treatment.
• Active ulcerative colitis or Crohn's disease.
• Antibiotic therapy within previous 3 months.
• Diarrhoea from recent foreign travel.
• Known HIV or Hepatitis B positive.
• Working directly on specific study for which samples are required.
• Line managed or supervised by PI of study.

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

University of Aberdeen

Aberdeen, Scotland, AB25 2ZD, United Kingdom

Location

Related Publications (16)

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  PMID: 37414899 RESULT

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  PMID: 24018052 RESULT

• Bui TPN, Manneras-Holm L, Puschmann R, Wu H, Troise AD, Nijsse B, Boeren S, Backhed F, Fiedler D, deVos WM. Conversion of dietary inositol into propionate and acetate by commensal Anaerostipes associates with host health. Nat Commun. 2021 Aug 10;12(1):4798. doi: 10.1038/s41467-021-25081-w.

  PMID: 34376656 RESULT

• Allott EH, Howard LE, Cooperberg MR, Kane CJ, Aronson WJ, Terris MK, Amling CL, Freedland SJ. Serum lipid profile and risk of prostate cancer recurrence: Results from the SEARCH database. Cancer Epidemiol Biomarkers Prev. 2014 Nov;23(11):2349-56. doi: 10.1158/1055-9965.EPI-14-0458. Epub 2014 Oct 10.

  PMID: 25304929 RESULT

• Zhu S, Hu X, Fan Y. Association of triglyceride levels and prostate cancer: a Mendelian randomization study. BMC Urol. 2022 Oct 31;22(1):167. doi: 10.1186/s12894-022-01120-6.

  PMID: 36316671 RESULT

• Tabrizi R, Ostadmohammadi V, Lankarani KB, Peymani P, Akbari M, Kolahdooz F, Asemi Z. The effects of inositol supplementation on lipid profiles among patients with metabolic diseases: a systematic review and meta-analysis of randomized controlled trials. Lipids Health Dis. 2018 May 24;17(1):123. doi: 10.1186/s12944-018-0779-4.

  PMID: 29793496 RESULT

• Ligresti A, Moriello AS, Starowicz K, Matias I, Pisanti S, De Petrocellis L, Laezza C, Portella G, Bifulco M, Di Marzo V. Antitumor activity of plant cannabinoids with emphasis on the effect of cannabidiol on human breast carcinoma. J Pharmacol Exp Ther. 2006 Sep;318(3):1375-87. doi: 10.1124/jpet.106.105247. Epub 2006 May 25.

  PMID: 16728591 RESULT

• Keizman D, Frenkel M, Peer A, Kushnir I, Rosenbaum E, Sarid D, Leibovitch I, Mano R, Yossepowitch O, Margel D, Wolf I, Geva R, Dresler H, Rouvinov K, Rapoport N, Eliaz I. Modified Citrus Pectin Treatment in Non-Metastatic Biochemically Relapsed Prostate Cancer: Results of a Prospective Phase II Study. Nutrients. 2021 Nov 28;13(12):4295. doi: 10.3390/nu13124295.

  PMID: 34959847 RESULT

• Tabung F, Steck SE, Su LJ, Mohler JL, Fontham ET, Bensen JT, Hebert JR, Zhang H, Arab L. Intake of grains and dietary fiber and prostate cancer aggressiveness by race. Prostate Cancer. 2012;2012:323296. doi: 10.1155/2012/323296. Epub 2012 Nov 13.

  PMID: 23213538 RESULT

• Blanco-Perez F, Steigerwald H, Schulke S, Vieths S, Toda M, Scheurer S. The Dietary Fiber Pectin: Health Benefits and Potential for the Treatment of Allergies by Modulation of Gut Microbiota. Curr Allergy Asthma Rep. 2021 Sep 10;21(10):43. doi: 10.1007/s11882-021-01020-z.

  PMID: 34505973 RESULT

• Ewaschuk JB, Dieleman LA. Probiotics and prebiotics in chronic inflammatory bowel diseases. World J Gastroenterol. 2006 Oct 7;12(37):5941-50. doi: 10.3748/wjg.v12.i37.5941.

  PMID: 17009391 RESULT

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  PMID: 32049008 RESULT

• Then CK, Paillas S, Wang X, Hampson A, Kiltie AE. Association of Bacteroides acidifaciens relative abundance with high-fibre diet-associated radiosensitisation. BMC Biol. 2020 Aug 19;18(1):102. doi: 10.1186/s12915-020-00836-x.

  PMID: 32811478 RESULT

• de Vos II, Luiting HB, Roobol MJ. Active Surveillance for Prostate Cancer: Past, Current, and Future Trends. J Pers Med. 2023 Apr 3;13(4):629. doi: 10.3390/jpm13040629.

  PMID: 37109015 RESULT

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• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 RESULT

Related Links

• NDNS: results from years 9 to 11 (2016 to 2017 and 2018 to 2019)
• National Prostate Cancer Audit (NPCA), NPCA State of the Nation Report

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be stored until the study has been completed and then for further 5 years to allow for potential additional analysis in future ethically reviewed and approved studies. Anonymised 16S rRNA gene-based gut microbiota profiling sequence data will be uploaded to a publicly accessible data repository prior to publication.

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Anne E Kiltie, MA, DN, DSc

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: November 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: October 31, 2025
• Last Updated: April 30, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)