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Trial registered on ANZCTR


Registration number
ACTRN12624001271594
Ethics application status
Approved
Date submitted
2/10/2024
Date registered
18/10/2024
Date last updated
18/10/2024
Date data sharing statement initially provided
18/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Lifestyle Modification Program and Supplementation with Dietary Fibre on Metabolic Health in overweight adults.
Scientific title
Impact of lifestyle modification program with and without dietary fibre supplementation on body weight and composition, and metabolic health biomarkers in overweight adults.
Secondary ID [1] 308638 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 328550 0
Metabolic Syndrome 328551 0
Gastrointestinal disorders 328552 0
Condition category
Condition code
Diet and Nutrition 325566 325566 0 0
Obesity
Metabolic and Endocrine 325567 325567 0 0
Metabolic disorders
Oral and Gastrointestinal 325568 325568 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Allocation: Randomised
Intervention Model: Parallel assignment
Intervention Model Description: Randomised, double-blind, controlled study with unblinded lifestyle modification advice, parallel assignment

Participants were randomly assigned into one of four groups (A-D):
A, the Control group that received a placebo (rice powder);
B, which received a novel dietary fibre (BioPB);
C, which received lifestyle modification advice (LSMA, AstonRx Program) plus psyllium;
D, received the LSMA plus BioPB.

Intervention details: The intervention period was four weeks. During the intervention period, participants consumed either 4.2 g of BioPB, psyllium, or placebo twice daily, sprinkled over meals. BioPB comprised equal proportions of Carrageenan, Konjac and cellulose (hence about 60% soluble fibre and 40% insoluble fibre). After the cessation of the intervention period, participants were followed up for an additional four weeks.
Seventy -seven subjects were randomly assigned to four groups and 67 completed the study.
LSMA (AstonRx Program): A 28-day customised online lifestyle modification program that provides participants access to an Interactive dashboard that delivers education, and a detailed daily meal plan with portion sizes (incorporating diverse fibrous plant foods) based on an individual’s lean body weight. It also instructs participants to follow time-restricted eating (TRE - circadian) and avoid consuming alcohol, sugar, refined CHO or artificial sweeteners. The program commences with 3 meals a day, with a minimum 5-hour fast between meals and a minimum 12-hour overnight fast. Participants are encouraged to finish eating during daylight hours and at least 3-4 hours before sleep. From Day 10 onwards, participants have increased metabolic flexibility and may opt for 2 meals a day on any day they wish.
Intervention code [1] 325102 0
Lifestyle
Intervention code [2] 329730 0
Prevention
Comparator / control treatment
The Control group will receive a placebo (rice powder), with no lifestyle/dietary modification.
Control group
Placebo

Outcomes
Primary outcome [1] 333403 0
Safety and tolerability will be assessed as composite outcomes. These will be assessed by monitoring the levels of liver and kidney enzymes in the blood, and side effects such as gastrointestinal discomfort, bloating, constipation, stool frequency and consistency, and monitoring the health-related quality of life using RAND 36 Item Short Form Health Survey and Gastrointestinal Symptoms and Stool Output Questionaire.
Timepoint [1] 333403 0
Baseline (week 0), after 4 weeks of supplementation/intervention (Week 4) and then 4 weeks of follow-up (Week 8).
Primary outcome [2] 333404 0
Changes in body weight, waist circumference, waist-to-height ratio, and waist-to-height ratio will be assessed as composite outcomes. Anthropometric measurements were performed using the Stadiometer (BSM370, InBody Body Composition Analyser, and body composition by using a bioelectrical impedance body composition analyser (InBody 570®, InBody Body Composition Analyser).
Timepoint [2] 333404 0
At baseline (week 0), after 4 weeks of intervention (Week 4), and again 4 weeks post-intervention (Week 8).
Primary outcome [3] 333405 0
Changes in body composition (body fat mass, visceral fat levels, % body fat, total body water, protein, minerals, soft lean mass, fat-free mass and skeletal muscle mass) were assessed using a bioelectrical impedance body composition analyser (InBody 570®, InBody Body Composition AnalysersPty Ltd, Queensland, Australia).
Timepoint [3] 333405 0
At baseline (week 0), after 4 weeks of intervention (Week 4), and again 4 weeks post-intervention (Week 8).
Secondary outcome [1] 416939 0
Changes in gut microbiota structure (composition) and function (short-chain fatty acid production) were assessed as a composite outcome. The stool microbiota composition was assessed using 16S rRNA gene sequencing and SCFA concentrations by LC-MS.
Timepoint [1] 416939 0
At baseline (week 0) and after 4 weeks of intervention (week 4)
Secondary outcome [2] 416940 0
Changes in blood lipid profiles, fasting glucose, and insulin levels were assessed as a composite outcome. These were measured using standard blood analysis techniques by NutriPath (Melbourne) (https://nutripath.com.au/).
Timepoint [2] 416940 0
At baseline (week 0), after 4 weeks of intervention (Week 4), and again 4 weeks post-intervention (Week 8).
Secondary outcome [3] 423707 0
Changes in high-sensitivity CRP (inflammation marker) levels. The levels of hs-CRP were assessed by NutriPath (Melbourne) (https://nutripath.com.au/)
Timepoint [3] 423707 0
At baseline (week 0), after 4 weeks of intervention (Week 4), and again 4 weeks post-intervention (Week 8).
Secondary outcome [4] 423708 0
Changes in dietary habits, This was assessed using 3-day food diary records.
Timepoint [4] 423708 0
At baseline (week 0), after 4 weeks of intervention (Week 4), and again 4 weeks post-intervention (Week 8).
Secondary outcome [5] 440559 0
Change in physical activity. This was assessed by administering a four-day physical activity questionnaire specifically designed for the study
Timepoint [5] 440559 0
At baseline (week 0), 4 weeks after the intervention (week 4) , and after 4 weeks of follow-up (week 8).

Eligibility
Key inclusion criteria
Age: 19 -65 years
Gender: Both male and female
BMI: 25 - 29.9 kg/m2
Able and willing to provide written consent to enroll in the study and comply with the study guidelines
Willingness to provide dietary records (days 0, 28 and 56), and blood and stool samples (self-collected) on days 0, 28 and 56 of the study
Willingness to maintain and provide information on bowel movement frequency, stool consistency and GI symptoms at weekly intervals during the intervention period.
Minimum age
19 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable or unwilling to give informed consent;

Do not meet the BMI criteria

History of diverticulitis; allergy or intolerance to the treatment dietary fibre; use of glucose-lowering medications (e.g. diabetes medications) or use of medications known to influence body weight (e.g. GLP-1 receptor agonists, certain antidepressants), lipid metabolism (e.g. cholesterol medications) or gut function; use of proton pump inhibitors (e.g. esomeprazole used in the treatment of gastroesophageal reflux disease); history of gastrointestinal surgical interventions; coeliac disease; clinically diagnosed irritable bowel syndrome (IBS); diseases of the gallbladder; eating disorders; pregnant, planning to be pregnant or breastfeeding at any point during the study; regular intake of laxatives in the past month and during the study; a history of eating disorders; documented chronic diseases including Type 1 diabetes, hyperthyroidism, cancer, liver or renal failure; currently enrolled in another study; anaemic and difficulty with blood draws; or presence of psychiatric disorders.

Additional exclusion criteria include weight unstable in the previous 3 months (evident by a loss or gain of more than 10% of total body weight), taking other contraindicated medication (i.e., antibiotics, psychotropic drugs or appetite suppressants), or use of any dietary supplement that might interfere with the results of the study.

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 conducted off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was via stratified, block randomisation using the random number generator in Microsoft Excel, with stratification according to gender, BMI, and whether participants have had an appendectomy, a cholecystectomy or neither.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The blood biochemistry, anthropometric and body composition data, blood pressure and pulse data were assessed for the assumption of normality and homoscedasticity using the Shapiro-Wilk test and Levene's test, respectively. Within and between groups differences in results (pre- and post-intervention) were analysed using the Friedman test followed by Dunn’s post hoc test. Differences between groups were analysed using Kruskal-Wallis ANOVA followed by Dunn’s post hoc test. Changes between groups or weeks were considered significant if p was > 0.05..

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/04/2023
Date of last participant enrolment
Anticipated
Actual
19/04/2023
Date of last data collection
Anticipated
Actual
3/07/2023
Sample size
Target
100
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312873 0
Government body
Name [1] 312873 0
Australian Government Department for Industry, Innovation and Science
Country [1] 312873 0
Australia
Funding source category [2] 312874 0
Commercial sector/Industry
Name [2] 312874 0
Aston Rx Pty Ltd
Country [2] 312874 0
Australia
Primary sponsor type
Government body
Name
Australian Government Department for Industry, Innovation and Science
Address
Australian Government Department for Industry, Innovation and Science, Industry House,10 Binara Street,Canberra
Country
Australia
Secondary sponsor category [1] 314547 0
Commercial sector/Industry
Name [1] 314547 0
Aston Rx
Address [1] 314547 0
9-11 Claremont St, South Yarra, VIC 3141
Country [1] 314547 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312153 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 312153 0
Ethics committee country [1] 312153 0
Australia
Date submitted for ethics approval [1] 312153 0
20/12/2022
Approval date [1] 312153 0
24/03/2023
Ethics approval number [1] 312153 0

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

Contacts
Principal investigator
Name 123662 0
Prof Harsharn Gill
Address 123662 0
Bld 203, RMIT Bundoora West Campus, Plenty Road, Bundoora VIC 3083
Country 123662 0
Australia
Phone 123662 0
+61 3 9925 2600
Fax 123662 0
Email 123662 0
harsharn.gill@rmit.edu.au
Contact person for public queries
Name 123663 0
Harsharn Gill
Address 123663 0
Bld 203, RMIT Bundoora West Campus), Plenty Road, Bundoora, VIC 3083
Country 123663 0
Australia
Phone 123663 0
+61 3 9925 2600
Fax 123663 0
Email 123663 0
harsharn.gill@rmit.edu.au
Contact person for scientific queries
Name 123664 0
Harsharn Gill
Address 123664 0
Bld 203, RMIT Bundoora West Campus), Plenty Road, Bundoora, VIC 3083
Country 123664 0
Australia
Phone 123664 0
+61 3 9925 2600
Fax 123664 0
Email 123664 0
harsharn.gill@rmit.edu.au

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19355Ethical approval  harsharn.gill@rmit.edu.au 385151-(Uploaded-08-10-2024-15-50-44)-26096 Gill - Notice of approval.pdf



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.