Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000198820
Ethics application status
Approved
Date submitted
25/01/2012
Date registered
16/02/2012
Date last updated
5/02/2021
Date data sharing statement initially provided
5/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
21 day trial into the weight reduction effects of supplementation with 1g and 500mg SolaThin.
Scientific title
21 day trial into the weight reduction effects of supplementation with 1g and 500mg SolaThin in adults aged between 18 and 40 with a Body Mass Index (BMI) of over 30.
Secondary ID [1] 279794 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
weight and appetite in overweight and obese individuals 285675 0
Condition category
Condition code
Diet and Nutrition 285857 285857 0 0
Obesity
Alternative and Complementary Medicine 285859 285859 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SolaThin is an extract of pure potato protein consisting of several low molecular weight proteins, including protease inhibitor PI-2. It has been suggested that certain protease inhibitor fractions may lead to a reduction in food intake via modulation of Cholecystokinin (CCK) levels.

On the testing days participants will have weight, height and body measurements recorded and complete baseline mood and appetite questionnaires. Participants will then consume one beverage pre-prepared by the investigator containing SolaThin Supplement or matching placebo. 20 minutes after the consumption of the treatment participants will complete the mood and appetite questionnaires again and have a series of blood tests taken.
At the end of testing day one, participants will be given their 21 day allotment of beverages containing the same treatment as the testing day and counselled on the appropriate way to consume the beverages. Participants will be required to consume the beverage 20 minutes before all main meals (three times a day) for the 21 days.

Testing day two will be the same as testing day one however participants will also have energy intake measured (assessed by analysis of buffet food intake)

The 3 treatments are:
- 500mg SolaThin (see details below)
- 1g SolaThin (see details below)
- Placebo (matched for taste and appearance)
Beverages will consist of 200 ml water mixed with one sachet of treatment.

SolaThin Nutritional Analysis
NUTRIENTS PER 1 gram of SolaThin trademark
TOTAL CARBOHYDRATE 14 mg
PROTEIN, 6.25 factor 946 mg
SODIUM 1.87 mg
IRON 0.004 mg

Amino Acids (g) Per 100 Grams
Alanine 2.79
Arginine <0.10
Aspartic Acid 12.17
Cysteine 0.34
Cystine 0.12
Glutamic Acid 7.16
Glutamine 0.18
Glycine 5.14
Histidine 1.68
Isoleucine 7.91
Leucine 7.96
Lysine 12.51
Methionine 1.99
Phenylalanine 1.24
Proline 4.82
Serine 5.55
Threonine 4.70
Tryptophan 1.89
Tyrosine 5.23
Valine <0.10

Minerals Per 100 Grams
Calcium 8.2 mcg
Cobalt 1.2 mcg
Copper 1.7 mcg
Iron 546.3 mcg
Magnesium 3.53 mg
Manganese 124.0 mcg
Phosphorus 3.0 mg
Potassium 6.0 mcg
Selenium 210.2 mcg
Sodium 40.5 mg
Zinc 2.4 mg

Vitamins Per 10 Grams
Beta-Carotene 34.0 IU
Biotin (B7) 8.2 mcg
Choline 3.8 mg
Pyrodixie (B6) 40 mcg
Riboflavin (B2) 460 mcg
Thiamin (B) 3.2 mcg
Vitamin E 0.47 IU
Vitamin K 4.3 mcg
Intervention code [1] 284115 0
Prevention
Intervention code [2] 284116 0
Behaviour
Comparator / control treatment
500mg equivilant Placebo (matched for taste and appearance)
Control group
Placebo

Outcomes
Primary outcome [1] 286359 0
Weight, height and body measurements.

Weight, height, waist, hip, upper arm, thigh and chest circumference and percent body fat will be measured during a clinical assessment by a trained technician/Research Assistant using a sensitive scientific scale and tape measure. Body Mass Index (BMI) will also be calculated.
Timepoint [1] 286359 0
To capture any weight loss effects participant height, weight, body fat, and body measurements will be measured at baseline on day 1 and at visit two following the 21 day intervention.
Primary outcome [2] 286360 0
Appetite as measured by self-ratings of hunger, thirst, fullness, desire to eat, prospective eating and nausea
Timepoint [2] 286360 0
Participants will be asked to complete appetite scales prior to one meal (i.e. 20 min following either SolaThin or placebo) twice per week. The meal (breakfast, lunch, dinner) will be varied so that there will be 2 measures for each meal for each participant. At the end of the 21 day period they will return to the lab and complete the same assessments as day 1.
Secondary outcome [1] 295670 0
Energy intake (assessed by analysis of buffet food intake)
Timepoint [1] 295670 0
Measured at visit two following the 21 day intervention.
Secondary outcome [2] 295671 0
Mood (alert, calm, content, stress, fatigue, tiredness)
Timepoint [2] 295671 0
Participants will be asked to complete mood scales prior to one meal (i.e. 20 min following either SolaThin or placebo) twice per week. The meal (breakfast, lunch, dinner) will be varied so that there will be 2 measures for each meal for each participant. At the end of the 21 day period they will return to the lab and complete the same assessments as day 1.
Secondary outcome [3] 295672 0
Levels of cholecystokinin, leptin, ghrelin and adiponectin.
Timepoint [3] 295672 0
5 blood samples will be collected via a cannula over the course of each testing session at baseline prior to consumption of beverage and then, 20, 50, 80 and 100 minutes post-beverage.

Eligibility
Key inclusion criteria
Participants who meet the following eligibility criteria will be recruited in the trial:
1. Males and females aged 18-40 with Body Mass Index (BMI) >30, otherwise healthy.
2. Are comfortable with computers and willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol.
3. Are comfortable with taking a daily supplement of SolaThin or Placebo for 21 days.
4. Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants presenting with any of the following will not be included in the trial:

1. History of anxiety, depression, psychiatric disorders.
2. History of / do not currently suffer from heart disease or high blood pressure or diabetes
3. Taking any medication, herbal extracts, vitamin supplements or illicit drugs for 4 weeks prior to (and duration of) study
4. Taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
5. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers)
6. Renal function problems, Hypercalcaemia; Hypermagnesemia, Severe hypercalciuria, phenylketonuria (autosomal metabolic disorder),
7. Currently pregnant or lactating

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)
To minimize bias this study will employ both randomization and blinding.

Randomization of participants will be achieved using a random number generator. Eligible, recruited participants will be assigned a participant number. The randomisation that has been placed next to the participant’s number will be the allocated treatment for that individual.

Blinding will be achieved by enlisting a person not involved with data collation or analysis to code the treatments, and maintain the key to this code until data collection is completed. The codes will only be broken in an emergency, such as an SAE that requires knowledge of the treatment being taken in order to manage a participant’s condition. The principle investigator, sponsor and ethics committee will be informed within 24 hours of the code-break envelope being opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party will generate the randomisation sequence using a computerised sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/03/2012
Actual
16/04/2012
Date of last participant enrolment
Anticipated
Actual
28/11/2012
Date of last data collection
Anticipated
Actual
19/12/2012
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284574 0
Commercial sector/Industry
Name [1] 284574 0
CYVEX NUTRITION, INC
Country [1] 284574 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CYVEX NUTRITION, INC
Address
1851 Kaiser Avenue
Irvine, CA 92614
Country
United States of America
Secondary sponsor category [1] 283491 0
None
Name [1] 283491 0
Address [1] 283491 0
Country [1] 283491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286559 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 286559 0
Ethics committee country [1] 286559 0
Australia
Date submitted for ethics approval [1] 286559 0
Approval date [1] 286559 0
21/12/2011
Ethics approval number [1] 286559 0
SUHREC Project 2011/219

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

Contacts
Principal investigator
Name 33680 0
Prof Prof Andrew Scholey
Address 33680 0
Centre for Human Psychopharmacology
Swinburne University of Technology
H24, Po Box 218 Hawthorn, Vic, 3122
Country 33680 0
Australia
Phone 33680 0
+61392148932
Fax 33680 0
Email 33680 0
[email protected]
Contact person for public queries
Name 16927 0
Rebecca King
Address 16927 0
H24, Po Box 218
Hawthorn, Vic, 3122
Country 16927 0
Australia
Phone 16927 0
613 92145087
Fax 16927 0
Email 16927 0
[email protected]
Contact person for scientific queries
Name 7855 0
Professor Andrew Scholey
Address 7855 0
H24, Po Box 218
Hawthorn, Vic, 3122
Country 7855 0
Australia
Phone 7855 0
613 9214 8932
Fax 7855 0
Email 7855 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


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.