Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001094763
Ethics application status
Approved
Date submitted
3/08/2022
Date registered
8/08/2022
Date last updated
8/08/2022
Date data sharing statement initially provided
8/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a nutritional supplement on gastrointestinal, immune and metabolic health
Scientific title
Effect of a nutritional supplement on gastrointestinal, immune and metabolic outcomes at rest and in response to a metabolic exercise challenge in healthy, sedentary adults
Secondary ID [1] 307692 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary adults 327239 0
Metabolic dysfunction 327240 0
Condition category
Condition code
Diet and Nutrition 324378 324378 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 324401 324401 0 0
Metabolic disorders
Inflammatory and Immune System 324402 324402 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will be sedentary, but otherwise healthy adults. They will consume a daily dose of a commercial powdered dietary supplement containing wheatgrass, barley grass, chlorella, and spirulina for 8 weeks. Participants will consume 1 teaspoon per day, dissolved in a beverage. Supplement that is not consumed will be returned to the study team to monitor compliance.
Prior to, and after the 8 weeks, participants will take part in an individual metabolic challenge supervised by qualified research staff. Participants will consume a pre-exercise breakfast beverage (approx 7% Energy (E) protein, 30%E CHO, 63%E fat), then 2 h later undertake light exercise (walking on an incline at 60% VO2max) in heat conditions (35deg C), until exhaustion (participant decides not to continue).
Every 15 minutes during exercise, participants will be asked to provide: a Borg Rating of Perceived Exertion (RPE); a Rating of Thermal Comfort; and an indicator of gastrointestinal discomfort. Participant heart rate and tympanic temperature will also be monitored.
Intervention code [1] 324166 0
Treatment: Other
Comparator / control treatment
Powdered cellulose-based placebo, colour-matched to the supplement
Control group
Placebo

Outcomes
Primary outcome [1] 332179 0
Gastrointestinal marker: Plasma Intestinal Fatty Acid Binding Protein (I-FAB) response to the metabolic challenge test
Timepoint [1] 332179 0
Baseline and 8 weeks after intervention commencement
Primary outcome [2] 332182 0
Gastrointestinal marker: Response of plasma sCD14 to metabolic challenge test
Blood sample


Timepoint [2] 332182 0
Baseline, and 8 weeks after intervention commencement
Primary outcome [3] 332196 0
Immune markers: White blood cell count - response to the metabolic challenge test
Blood sample
Timepoint [3] 332196 0
Baseline, 8 weeks after intervention commencement
Secondary outcome [1] 412493 0
Subjective measures of wellness
Quality of life (World Health Organization Quality of life questionnaire)
Timepoint [1] 412493 0
Baseline, 8 weeks after intervention commencement
Secondary outcome [2] 412494 0
Metabolic markers: Blood glucose
Timepoint [2] 412494 0
Baseline, 8 weeks after intervention commencement
Secondary outcome [3] 412516 0
Hepatic markers: Serum alanine aminotransferase (ALT)
Timepoint [3] 412516 0
Baseline, 8 weeks after intervention commencement
Secondary outcome [4] 412567 0
Subjective measures of wellness:
Vitality (Scale of vitality questionnaire)
Timepoint [4] 412567 0
Basleine, 8 weeks after intervention commencement
Secondary outcome [5] 412568 0
Metabolic markers: Serum insulin
Timepoint [5] 412568 0
Baseline, 8 weeks after commencement of intervention
Secondary outcome [6] 412569 0
Metabolic markers: Serum triglycerides
Timepoint [6] 412569 0
Baseline, 8 weeks after commencement of intervention
Secondary outcome [7] 412570 0
Hepatic markers: Serum aspartate transaminase (AST)
Timepoint [7] 412570 0
Baseline, 8 weeks after commencement of intervention
Secondary outcome [8] 412571 0
Hepatic markers: Serum gamma-glutamyl transferase (GGT)
Timepoint [8] 412571 0
Baseline, 8 weeks after commencement of intervention
Secondary outcome [9] 412572 0
Hepatic markers: Serum alkaline phosphatase (ALP)
Timepoint [9] 412572 0
Baseline, 8 weeks after commencement of intervention

Eligibility
Key inclusion criteria
Male and female adults engaged in < 150 minutes of structure exercise or sport per week
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed to both researchers and participants by use of labelled containers (A or B). Treatment allocation will only be revealed at the completion of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311961 0
Commercial sector/Industry
Name [1] 311961 0
Melrose Laboratories Pty Ltd
Country [1] 311961 0
Australia
Funding source category [2] 311963 0
Government body
Name [2] 311963 0
Department of Industry, Science and Resources
Country [2] 311963 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Nutrition, Dietetics & Food
Level 1, 264 Ferntree Gully Rd
Notting Hill, VIC 3168
Country
Australia
Secondary sponsor category [1] 313447 0
None
Name [1] 313447 0
Address [1] 313447 0
Country [1] 313447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311391 0
Monash University HREC
Ethics committee address [1] 311391 0
Ethics committee country [1] 311391 0
Australia
Date submitted for ethics approval [1] 311391 0
14/03/2022
Approval date [1] 311391 0
08/06/2022
Ethics approval number [1] 311391 0
32041

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120930 0
Dr Aimee Dordevic
Address 120930 0
Department of Nutrition, Dietetics & Food, Monash University
Level 1, 264 Ferntree Gully Rd
Notting Hill, VIC 3168
Country 120930 0
Australia
Phone 120930 0
+61399052142
Fax 120930 0
Email 120930 0
[email protected]
Contact person for public queries
Name 120931 0
Aimee Dordevic
Address 120931 0
Department of Nutrition, Dietetics & Food, Monash University
Level 1, 264 Ferntree Gully Rd
Notting Hill, VIC 3168
Country 120931 0
Australia
Phone 120931 0
+61399052142
Fax 120931 0
Email 120931 0
[email protected]
Contact person for scientific queries
Name 120932 0
Aimee Dordevic
Address 120932 0
Department of Nutrition, Dietetics & Food, Monash University
Level 1, 264 Ferntree Gully Rd
Notting Hill, VIC 3168
Country 120932 0
Australia
Phone 120932 0
+61399052142
Fax 120932 0
Email 120932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality and ethical limitations


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.