Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000685516
Ethics application status
Approved
Date submitted
16/05/2024
Date registered
29/05/2024
Date last updated
29/05/2024
Date data sharing statement initially provided
29/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Discovering the effect of plant natural products on appetite and fullness in healthy overweight adults
Scientific title
Screening for the effectiveness of appetite-suppressing and satiety-increasing natural bioactive compounds in healthy overweight adults
Secondary ID [1] 312161 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 333813 0
Condition category
Condition code
Diet and Nutrition 330481 330481 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to investigate the effectiveness of the satiety-prolonging and appetite-suppressing effects of natural plant extracts, including Momordica charantia, Caralluma fimbriata, Gymnema sylvestre, and Humulus lupulus, on healthy, overweight individuals.

This randomized, double-blinded, crossover study will be conducted at the Be Active Sleep Eat (BASE) Facility, Monash University. The study consists of an initial screening and five treatment sessions. Participants first complete an online pre-screening questionnaire to determine eligibility. Those who meet the criteria are invited for an in-person visit at the BASE Facility, where researchers measure their height and weight, provide a detailed briefing on the study procedures, and obtain informed consent.

Each participant required to attend a total of 5 treatment sessions (4 interventions and one placebo). Participants are advised to avoid alcohol and strenuous exercise for 24 hours before each treatment session and to fast from 9 PM the previous night. On the day of each session, participants arrive at the facility at 8 AM. Researchers measure their height, weight, and body composition using multi-frequency Bioelectrical Impedance Analysis (mBIA). Throughout each visit, participants complete several questionnaires assessing their feelings related to appetite, mood, food cravings, gastrointestinal condition, and perceptions of the food provided. Participants then consume a fixed-calorie breakfast (approximate calorie content: 1700 kJ). They are advised to finish the breakfast within 15 minutes. Two and a half hours later, they ingest a treatment capsule containing 500 mg of either a plant extract (Momordica charantia, Caralluma fimbriata, Gymnema sylvestre, or Humulus lupulus) or a placebo.

An hour after capsule administration, participants eat a standard lunch and can eat as much as they like within a duration of 30 minutes. After the standard lunch, participants complete the same questionnaires again until 2 PM.

Additionally, they maintain a 24-hour diet diary until 12 PM the following day, documenting all food and beverage intake. A seven-day washout period is provided between each treatment session to ensure accurate results.

To ensure adherence to the intervention, trained researchers will directly supervise participants during key aspects of the study, including the consumption of study capsules, meals, and the completion of questionnaires.
Intervention code [1] 328607 0
Prevention
Intervention code [2] 328649 0
Treatment: Other
Comparator / control treatment
500 mg of maltodextrin encapsulated in opaque capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 338254 0
Difference in lunch intake
Timepoint [1] 338254 0
immediately after the lunch at each of the five treatment sessions.
Secondary outcome [1] 435164 0
The change in appetite-related scores. The scores will be assessed as a composite outcome.
Timepoint [1] 435164 0
The participants are required to complete several sets of questionnaires in each study visit, with breakfast serving time set as t= 0 min. The schedule is as follows:
16 sets of Hunger and satiety questionnaires (at t= 0min, t=15 min, t=30 min, t=45 min, t= 75 min, t=105 min, t= 135 min, t=165 min, t= 180 min, t= 210 min, t=240 min, t=255 min, t=270 min, t= 285 min, t=300 min, and t= 330 min)
5 sets of Mood questionnaires (t= 135 min, t=165 min, t= 210 min, t= 240 min, and t= 285 min)
2 sets of Perception of provided meal questionnaires (t=15 min, and t=240 min)
5 sets of Food craving questionnaires ( t= 135 min, t=165 min, t=210 min, t=240 min, and t=270 min)
5 sets of Gastrointestinal discomfort questionnaires ( t= 135 min, t=165 min, t=210 min, t=240 min, and t=300 min)

Eligibility
Key inclusion criteria
• 18 years or more
• Self-reported as healthy overweight adults with Body Mass Index (BMI) more than 25 kg/m2
• No known health conditions that may affect full participation (e.g., diabetes, cardiovascular disease, liver or thyroid dysfunction or recent major surgery)
• Not taking any medications that are known to affect appetite (e.g., diabetic medications, antidepressants, stimulants, appetite suppressants, and chemotherapy drugs)
• No gastrointestinal conditions (e.g., Crohn’s disease, ulcerative colitis, coeliac disease and/or recent gastrointestinal surgery involving any body parts involved in digestion)
• Not currently cigarette smoking and/or vaping
• Not currently pregnant or breastfeeding
• Have no known intolerance, sensitivity or allergic reaction to lactose, gluten and/or dairy products
• Able to adhere to the study protocol and consume every study food
• Available to attend six testing sessions at the Notting Hill BASE Facility
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
numbered container
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/05/2024
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 42587 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 316525 0
Commercial sector/Industry
Name [1] 316525 0
Access Business Group International LLC
Country [1] 316525 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318708 0
None
Name [1] 318708 0
None
Address [1] 318708 0
Country [1] 318708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315318 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315318 0
Ethics committee country [1] 315318 0
Australia
Date submitted for ethics approval [1] 315318 0
05/04/2024
Approval date [1] 315318 0
15/04/2024
Ethics approval number [1] 315318 0
42236

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

Contacts
Principal investigator
Name 134322 0
Dr Elizabeth Barber
Address 134322 0
Be Active Sleep Eat (BASE) Facility, L1, 264 Ferntree Gully Rd, Notting Hill VIC 3168
Country 134322 0
Australia
Phone 134322 0
+61 399024265
Fax 134322 0
Email 134322 0
[email protected]
Contact person for public queries
Name 134323 0
Woon Yao Chai
Address 134323 0
Be Active Sleep Eat (BASE) Facility, L1, 264 Ferntree Gully Rd, Notting Hill VIC 3168
Country 134323 0
Australia
Phone 134323 0
+61493972130
Fax 134323 0
Email 134323 0
[email protected]
Contact person for scientific queries
Name 134324 0
Woon Yao Chai
Address 134324 0
Be Active Sleep Eat (BASE) Facility, L1, 264 Ferntree Gully Rd, Notting Hill VIC 3168
Country 134324 0
Australia
Phone 134324 0
+61493972130
Fax 134324 0
Email 134324 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published result only
When will data be available (start and end dates)?
no start and end date determined
Available to whom?
case-by-case basis at the discretion of Primary Sponsor and Chief Investigator
Available for what types of analyses?
Only achieve the aims in the approved proposal, and meta analyses
How or where can data be obtained?
access subjected to approvals by Chef Investigator Dr. Elizabeth Barber (Email: [email protected])


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.