Effect of a nutritional supplement on gastrointestinal, immune and metabolic health

Not Applicable

• Conditions: Sedentary adults; Diet and Nutrition - Other diet and nutrition disorders; Metabolic dysfunction; Inflammatory and Immune System - Other inflammatory or immune system disorders; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12622001094763
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-08
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Male and female adults engaged in < 150 minutes of structure exercise or sport per week

Exclusion Criteria

Athletes
Anyone having experienced a musculoskeletal injury in the past 3 months.
Chronic disease (hypertension, dyslipidemia, diabetes) any gastrointestinal diseases (IBD, Coeliac Disease), irritable bowel syndrome (IBS) or dietary intolerances or food allergies.
Body mass index (BMI) less than 18 kg/m2 OR greater than 35 kg/m2.
Regular exposure to heat, eg sauna, hot yoga, hot water immersion.
Consumption of nutritional supplements such as plant extracts, prebiotics, probiotics, antioxidant supplements in the past 3 months.
Use of antibiotics or other medications in the past 3 months.
Current smokers, vapers or other recreational drug users.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal marker: Plasma Intestinal Fatty Acid Binding Protein (I-FAB) response to the metabolic challenge test[Baseline and 8 weeks after intervention commencement];Gastrointestinal marker: Response of plasma sCD14 to metabolic challenge test<br>Blood sample <br><br><br>[Baseline, and 8 weeks after intervention commencement];Immune markers: White blood cell count - response to the metabolic challenge test<br>Blood sample [Baseline, 8 weeks after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Subjective measures of wellness<br>Quality of life (World Health Organization Quality of life questionnaire)<br>[Baseline, 8 weeks after intervention commencement];Metabolic markers: Blood glucose[Baseline, 8 weeks after intervention commencement];Hepatic markers: Serum alanine aminotransferase (ALT)[Baseline, 8 weeks after intervention commencement];Subjective measures of wellness:<br>Vitality (Scale of vitality questionnaire)[Basleine, 8 weeks after intervention commencement];Metabolic markers: Serum insulin[Baseline, 8 weeks after commencement of intervention];Metabolic markers: Serum triglycerides[Baseline, 8 weeks after commencement of intervention];Hepatic markers: Serum aspartate transaminase (AST)[Baseline, 8 weeks after commencement of intervention];Hepatic markers: Serum gamma-glutamyl transferase (GGT)[Baseline, 8 weeks after commencement of intervention];Hepatic markers: Serum alkaline phosphatase (ALP)[Baseline, 8 weeks after commencement of intervention]