NCT06153719

Brief Summary

There are trillions of microorganisms living alongside us in our guts. Recent research has shown that this community, known as the gut microbiome, has a big influence on our health and wellbeing. Imbalances in the composition of the gut microbial community has been linked to several diseases including COVID, mental ill health, and diabetes. When the composition of the gut microbiome changes towards a less healthy one (called dysbiosis) this will, in turn, affect our health in a negative way. The composition of our gut microbiome remains fairly stable during adulthood, however, as we move into older age, there is a shift and its composition will change to a less healthy one; this is one of the reasons why older people can be more susceptible to diseases. Fortunately, there are several tools that we can use to improve our gut microbiome and one of them is exercise. Besides its well-known effects on our health, exercise has been shown to be able to improve the gut microbiome composition of younger people and those with certain metabolic diseases such as obesity. However, less is known about the effects of exercise on the gut microbiome of older adults. The aim of this study, therefore, is to assess the effects of a 12-week exercise intervention on the gut microbiome of physically inactive older adults. Hopefully, after this study, the investigators will have more information on whether exercise can be used as a tool to improve the gut microbiome of older adults therefore improving their overall health and quality of life.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

November 22, 2023

Last Update Submit

December 1, 2023

Conditions

Keywords

Gut microbiomeExercisePhysical activityPhysical inactivityOlder adultsGut microbiota

Outcome Measures

Primary Outcomes (1)

  • Gut microbiome composition

    Gut microbiome composition will be analysed using 16s rRNA sequencing

    At the begining and at the end of the intervention

Study Arms (2)

Exercise group

ACTIVE COMPARATOR
Other: 12-weeks combined exercise intervention

Control group

PLACEBO COMPARATOR
Other: 12-weeks combined exercise intervention

Interventions

This 12-week combined exercise intervention will consist of 3 supervised exercise classes per week, each one lasting 50 minutes. It will involve both aerobic and resistance training in order to follow the UK's physical activity recommendations

Control groupExercise group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged between 65-85 years old
  • Healthy, free-living individuals
  • Vaccinated against COVID-19
  • Physically inactive (\<150 mins/week of PA)
  • No participation in any exercise intervention studies in the last 3 months
  • BMI Between 20-35 kg/m2

You may not qualify if:

  • The use of antibiotics 3 months before or during the study
  • Cancer
  • Intestinal inflammatory conditions (e.g., Crohns, ulcerative colitis)
  • Consumption of proton pump inhibitors (e.g., omeprazole, lansoprazole, etc…)
  • Auto-immune diseases
  • GI diseases (e.g., IBS, peptic ulcers)
  • Routine consumption of pre and/or probiotic foods or supplements
  • On blood thinners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham Trent University - Clifton campus

Nottingham, United Kingdom

RECRUITING

Related Publications (6)

  • Ramos C, Gibson GR, Walton GE, Magistro D, Kinnear W, Hunter K. Systematic Review of the Effects of Exercise and Physical Activity on the Gut Microbiome of Older Adults. Nutrients. 2022 Feb 5;14(3):674. doi: 10.3390/nu14030674.

    PMID: 35277033BACKGROUND
  • Taniguchi H, Tanisawa K, Sun X, Kubo T, Hoshino Y, Hosokawa M, Takeyama H, Higuchi M. Effects of short-term endurance exercise on gut microbiota in elderly men. Physiol Rep. 2018 Dec;6(23):e13935. doi: 10.14814/phy2.13935.

    PMID: 30536648BACKGROUND
  • Erlandson KM, Liu J, Johnson R, Dillon S, Jankowski CM, Kroehl M, Robertson CE, Frank DN, Tuncil Y, Higgins J, Hamaker B, Wilson CC. An exercise intervention alters stool microbiota and metabolites among older, sedentary adults. Ther Adv Infect Dis. 2021 Jun 25;8:20499361211027067. doi: 10.1177/20499361211027067. eCollection 2021 Jan-Dec.

    PMID: 34262758BACKGROUND
  • Barton W, Penney NC, Cronin O, Garcia-Perez I, Molloy MG, Holmes E, Shanahan F, Cotter PD, O'Sullivan O. The microbiome of professional athletes differs from that of more sedentary subjects in composition and particularly at the functional metabolic level. Gut. 2018 Apr;67(4):625-633. doi: 10.1136/gutjnl-2016-313627. Epub 2017 Mar 30.

    PMID: 28360096BACKGROUND
  • Bressa C, Bailen-Andrino M, Perez-Santiago J, Gonzalez-Soltero R, Perez M, Montalvo-Lominchar MG, Mate-Munoz JL, Dominguez R, Moreno D, Larrosa M. Differences in gut microbiota profile between women with active lifestyle and sedentary women. PLoS One. 2017 Feb 10;12(2):e0171352. doi: 10.1371/journal.pone.0171352. eCollection 2017.

    PMID: 28187199BACKGROUND
  • Allen JM, Mailing LJ, Niemiro GM, Moore R, Cook MD, White BA, Holscher HD, Woods JA. Exercise Alters Gut Microbiota Composition and Function in Lean and Obese Humans. Med Sci Sports Exerc. 2018 Apr;50(4):747-757. doi: 10.1249/MSS.0000000000001495.

    PMID: 29166320BACKGROUND

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kirsty Hunter

    Nottingham Trent University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Associate

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 1, 2023

Study Start

December 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations