None listed
Conditions
Brief summary
Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease worldwide; progression and severity are influenced by systemic inflammation, lifestyle factors and body composition. With no pharmacological treatments available, exercise and diet are first-line treatments. The mechanisms by which lifestyle interventions influence NAFLD severity are unknown but may be related to inflammation and gut microbiome composition. We aim to examine whether gut microbiome composition and inflammation are related to NAFLD severity; and whether 12-weeks of exercise impacts gut microbiome , inflammation and NAFLD severity. This research will provide basis for identifying novel treatments for NAFLD by targeting the microbiome. This research will develop our understanding of how exercise improves NAFLD through modulation of gut microbiome diversity and inflammation. This will contribute to identifying effective exercise prescriptions that target underpinning mechanisms to improve health outcomes for patients with NAFLD and prevent disease progression. This in turn will contribute to better diagnosis/treatment when considering disease severity and outcomes for those with NAFLD. Additionally, assessment of potential changes in HRQoL of NAFLD patients in response to exercise training will verify real world efficacy, considering the gut microbiome and inflammation in NAFLD progression/severity. There is evidence showing that exercise-mediated changes to the gut microbiome influence biological variables known to be related to NAFLD severity and progression. However, research is yet to examine correlations between gut microbiome alpha diversity, key inflammatory markers, and body composition with NAFLD severity. Additionally, research is yet to examine the effects of a combined exercise program on gut microbiome composition in NAFLD. Research aimed at filling these gaps could inform the development of evidence-based recommendations for diagnostic, exercise, and treatment-related outcomes in patients with NAFLD and place SCUH Hepatology/Gastroenterology as a leading department in novel research and treatment in this field. SCUH has the expertise to undertake clinical data collection, as well as access to a large patient group and access to excellent laboratory facilities, however, the department does not have the expertise required to run clinical exercise interventions or assess inflammation or gut microbiome diversity.
Interventions
Initial phase (baseline assessment):
Participants recruited will undergo baseline measurements for cross-sectional analysis of all outcome measures.
-Liver fibrosis and steatosis
-Body composition
-General blood biochemistry
-Inflammatory cytokine levels
-Quality of life questionnaire
-Gut microbiome richness (stool samples)
-Cardiovascualr fitness
-Muscular strength
-Dietary intake
All initial testing will be completed over 2-3 days (over one or two weeks) at no more than 2.5 hours per session.
Initial phase (baseline assessment): Participants recruited will undergo baseline measurements for cross-sectional analysis of all outcome measures. -Liver fibrosis and steatosis -Body composition -General blood biochemistry -Inflammatory cytokine levels -Quality of life questionnaire -Gut microbiome richness (stool samples) -Cardiovascualr fitness -Muscular strength -Dietary intake All initial testing will be completed over 2-3 days (over one or two weeks) at no more than 2.5 hours per session. Interventional phase will start the following week straight after the initial assessments are completed. Intervention phase: Same participants from the initial phase will then participate in an exercise intervention 12 weeks of combined aerobic and resistance training for NAFLD patients - Supervised by a qualified Accredited exercise physiologist - Sessions will be in a group format 3-6 participants per group - Aerobic and resistance training will be at a moderate intensity measured through heart rate reserve with BORG RPE and % one rep maximum, respectively - Sessions will be conducted 3 days per week (12 weeks total), 30-35min aerobic training and ~30min resistance training (includes warm ups and cool down time) per session. - Session attendance and progression of fitness (increased workload when fitness improved) will be monitored and recorded The same outcome measeurements from baseline measurements will be collected after week 6 and week 12 of the exercise intervention.
Sponsors
Mr Christiaan Hattingh
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(i) A diagnosis of NAFLD (ii) No other liver disease or cancer present (iii) Other well-managed comorbidities, e.g. Type 2 Diabetes Mellitus (T2DM), and hypertension, are approved for the study (iv) No recent or current exercise performed (v) Commit to the cross-sectional study and assess for the longitudinal study (vi) Complete consent form
Exclusion criteria
(i) Younger than 18 years of age (ii) Serious cardiovascular, respiratory, or neurological diseases and cancers (iii) Poorly controlled hypertension, glucose regulation or other serious chronic diseases (iv) A disability that could prevent the completion of exercises (v) High-risk participants with contraindications to exercise (vi) Currently exercising more than 60 minutes per week (vii) Participation in conflicting studies (viii) Participants with internal artefacts that may obscure DXA readings (ix) Participants who are pregnant, attempting to conceive or lactating. (x) Participants exposed to radiation levels deemed unsafe in the DXA pre-testing preparation checklist. (xi) Participants who cannot complete the 1RM and VO2max protocols. (xii) Medications that could alter outcome measures
Outcome results
None listed