Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001011471
Ethics application status
Approved
Date submitted
22/08/2025
Date registered
11/09/2025
Date last updated
11/09/2025
Date data sharing statement initially provided
11/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a plant extract on weight loss in healthy overweight and obese participants
Scientific title
The effect of a plant extract on weight, body composition, appetite, and related hormone measures in a cohort of healthy overweight and obese participants
Secondary ID [1] 312562 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 334464 0
Condition category
Condition code
Diet and Nutrition 331080 331080 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hop extract intervention. Given in a delayed release hydroxypropyl methylcellulose oral capsule.
Daily Dosage:
Week 1: 125mg
Week2: 250mg
Week3: up to 375mg
Week4-24: up to 500mg

Individual participant sensitivity will be determined during the week 1-4 dose escalation period by self reported participant feedback on treatment tolerability.
Participants will continue on between 250-500mg for the rest of the study period. It is expected that the majority of participants will take 500mg, however, as previous studies have suggested some variability in sensitivity, the dosage will be matched to tolerability to maximize participant retention.
Compliance will be assessed monthly by study staff by assessing left over capsules.
Intervention code [1] 329075 0
Treatment: Other
Comparator / control treatment
Calorie-matched placebo control capsule containing canola oil. Given in same delayed resistant capsule using the same dose escalation
Week 1: 125mg canola oil
Week2: 250mg canola oil
Week3: up to 375mg canola oil
Week4-24: up to 500mg canola oil
Control group
Placebo

Outcomes
Primary outcome [1] 338852 0
Body Weight
Timepoint [1] 338852 0
Baseline, 4,8,12,16,20 and 24 weeks (Primary timepoint) after treatment start, 6 weeks and 12 weeks post treatment completion.
Primary outcome [2] 338853 0
Body Composition
Timepoint [2] 338853 0
DEXA Scan at Baseline and after 24 weeks of treatment. Bioelectrical impedance analysis at Baseline, after 4,8,12,16,20 and 24 week (primary timepoint) treatment, and at 6 weeks and 12 weeks after completion of intervention.
Secondary outcome [1] 437682 0
Long term blood glucose
Timepoint [1] 437682 0
Baseline and after 24 weeks of treatment.
Secondary outcome [2] 450982 0
Glucagon Like Peptide-1 plasma levels
Timepoint [2] 450982 0
Will be assessed at baseline and then at 24 weeks
Secondary outcome [3] 450983 0
Plasma Peptide Tyrosine Tyrosine (PYY) concentration
Timepoint [3] 450983 0
baseline and at 24 weeks
Secondary outcome [4] 450984 0
Inflammation
Timepoint [4] 450984 0
baseline and at 24 weeks
Secondary outcome [5] 450985 0
Hunger
Timepoint [5] 450985 0
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks.
Secondary outcome [6] 450986 0
fullness
Timepoint [6] 450986 0
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks.
Secondary outcome [7] 451372 0
Energy Intake
Timepoint [7] 451372 0
Baseline, 12 weeks, 24 weeks

Eligibility
Key inclusion criteria
Male and pre-menopausal Female
BMI 25-35
Aged 18-45 years
Normal gross gastrointestinal tract anatomy, as ascertained by self-report
Generally healthy as ascertained by self-report
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI outside range
Any medical conditions or medications known to affect appetite -related parameters, including depression, diabetes and glucose intolerance or supplements that regulate appetite.
Participation in an active diet program and/or loss/gain of >10% body weight within the last 6 months
Smoker or ex-smoker who quit within the last 6 months
Hypersensitivities or allergies to any ingredients included in the study capsules
Dislike and/or unwilling to follow dietary recommendations.
Unwilling/unable to comply with study protocol
Conditions effecting the gastrointestinal tract
Participating in another clinical intervention trial
Abnormal hunger and meal patterns, as ascertained by self-assessment
Trying or likely to get pregnant
Likely or planning to either start or stop taking hormonal-based contraception during the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2025
Actual
Date of last participant enrolment
Anticipated
15/10/2025
Actual
Date of last data collection
Anticipated
30/03/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 27312 0
New Zealand
State/province [1] 27312 0

Funding & Sponsors
Funding source category [1] 316989 0
Government body
Name [1] 316989 0
New Zealand institute for bioeconomy science
Country [1] 316989 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand institute for bioeconomy science
Address
Country
New Zealand
Secondary sponsor category [1] 322286 0
None
Name [1] 322286 0
Address [1] 322286 0
Country [1] 322286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315744 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315744 0
Ethics committee country [1] 315744 0
New Zealand
Date submitted for ethics approval [1] 315744 0
04/12/2023
Approval date [1] 315744 0
24/04/2024
Ethics approval number [1] 315744 0

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

Contacts
Principal investigator
Name 135674 0
Dr Edward Walker
Address 135674 0
New Zealand Institute for Bioeconomy Science: 120 Mt Albert Road Sandringham Auckland 1025
Country 135674 0
New Zealand
Phone 135674 0
+64 210424306
Fax 135674 0
Email 135674 0
[email protected]
Contact person for public queries
Name 135675 0
Edward Walker
Address 135675 0
New Zealand Institute for Bioeconomy Science: 120 Mt Albert Road Sandringham Auckland 1025
Country 135675 0
New Zealand
Phone 135675 0
+64 210424306
Fax 135675 0
Email 135675 0
[email protected]
Contact person for scientific queries
Name 135676 0
Edward Walker
Address 135676 0
New Zealand Institute for Bioeconomy Science: 120 Mt Albert Road Sandringham Auckland 1025
Country 135676 0
New Zealand
Phone 135676 0
+64 210424306
Fax 135676 0
Email 135676 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Journal publication or its supplementary materials: We plan to publish the deidentified primary outcome data and safety data for all the studies participants as supplementary materials.

Are there extra considerations when requesting access to individual participant data?
No


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.