NCT03344133

Brief Summary

Evidence suggests that gut microbiota contributes to the development of atherosclerosis and therefore CVDs. Exercise has been extensively reported to be protective against CVDs due to modification of body fatness, metabolic risk factors and cardio-respiratory fitness. It remains unclear whether impact of exercise on CVD risk can be at least in part explained by changes in the microbiota. It also remains to be investigated whether modification of appetite and appetite hormones due to participation in exercise are related to changes in the gut microbiota composition. Therefore, this study will be conducted in overweight, healthy, sedentary women and will investigate the effect of a 4-week moderate intensity exercise programme on gut microbiota composition and metabolic activity, plasma concentrations of fasting and postprandial lipids, glucose, insulin and inflammatory markers, fasting and postprandial gut appetite hormones, subjective appetite measures and cardio-respiratory fitness.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration 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

Study Start

First participant enrolled

September 16, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

September 19, 2017

Last Update Submit

November 14, 2017

Conditions

Overweight and Obesity

Keywords

ObesityExerciseCVD risk factorsAppetite RegulationGut Microbiota

Outcome Measures

Primary Outcomes (1)

  • Gut microbiota composition

    Changes in the gut microbiota composition measured by 16S rRNA amplicon sequencing.

    12 months

Secondary Outcomes (18)

  • Interleukin-6 (IL-6)

    3 months

  • Glucose

    3 months

  • Triglycerides

    3 months

  • Insulin

    3 months

  • Peptide YY (PYY)

    12 months

  • +13 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

4-week moderate intensity exercise programme

Behavioral: Exercise

Control

NO INTERVENTION

4 weeks of habitual life style

Interventions

ExerciseBEHAVIORAL

4-week moderate intensity exercise programme

Exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, sedentary females, BMI\>25 kg/m2, on a stable body weight for the last 3 months

You may not qualify if:

  • Acute or chronic illness, use of antibiotics the past 3 months, smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary

Glasgow, G312ER, United Kingdom

RECRUITING

MeSH Terms

Conditions

OverweightObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Konstantinos Gerasimidis, BSc MSc PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni Rizou, BSc MSc

CONTACT

e.rizou.1@research.gla.ac.uk

Konstantinos Gerasimidis, BSc MSc PhD

CONTACT

Konstantinos.Gerasimidis@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

September 19, 2017

First Posted

November 17, 2017

Study Start

September 16, 2015

Primary Completion

November 30, 2017

Study Completion

November 30, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)