Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000075189
Ethics application status
Approved
Date submitted
16/01/2019
Date registered
21/01/2019
Date last updated
11/02/2020
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of oral administration of lauric acid on gut hormone release and appetite perceptions in healthy people
Scientific title
Effects of oral administration of lauric acid on gut hormone release and appetite perceptions in healthy people
Secondary ID [1] 297033 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 311015 0
Type 2 diabetes
 311142 0
Healthy Human Gastrointestinal Physiology 311143 0
Condition category
Condition code
Diet and Nutrition 309662 309662 0 0
Obesity
Oral and Gastrointestinal 309663 309663 0 0
Normal oral and gastrointestinal development and function
Metabolic and Endocrine 309664 309664 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will consume, in randomized, double-blind fashion (cross-over design), capsules of i) 4.0g lauric acid (C12), ii) 2.0g C12, or iii) matching placebo (control). Each subject will receive each does once only on separate occasions. Study visits will be separated by 3-7 days. During study visits, the lead researchers will be present to closely monitor adherence to study protocol. On each study day, patients will attend the laboratory at ~08:00 hr, and a baseline calorimetry will be performed for 30 minutes. An intravenous catheter will then be inserted for blood sampling. At t=-2 min, a baseline blood sample will be taken and the subject will complete a VAS ratings. Immediately thereafter, subjects will ingest capsules of either (i) 4.0g C12 (ii), 2.0g C12 or (iii) control, with 200 ml of water, within 2 min. Blood samples and VAS questionnaires will be collected at 15-min intervals from t=0-60, and at 30-min intervals from t=60-180 min. Additional calorimetry measurements will be performed at t=60-90 and t=150-180. At t=180 min, after collection of a final blood sample and VAS ratings, the intravenous cannula will be removed, and subjects will be served a light meal after which they will be allowed to leave the laboratory. The light meal is chicken sandwich including wholemeal bread, chicken, tomato, cucumber, cheese, lettuce and water.
Intervention code [1] 313312 0
Treatment: Other
Comparator / control treatment
Placebo capsules including maltodextrin for within group comparison.
Control group
Placebo

Outcomes
Primary outcome [1] 318634 0
changes in gut hormones concentrations including cholecystokinin, PYY and ghrelin
This outcome is of an exploratory nature so that other gastrointestinal hormones to be measured may be decided upon based on the effect of the intervention on this and other outcomes.
Timepoint [1] 318634 0
Plasma will be obtained from blood samples taken at t = -2, 15, 30, 45, 60, 90, 120, 150, and 180 min.
Secondary outcome [1] 365876 0
Measure hunger sensation using a VAS questionnaire
Timepoint [1] 365876 0
VAS questionnaires will be completed at t = -2, 15, 30, 45, 60, 90, 120, 150 and 180 min.
Secondary outcome [2] 365877 0
Measure fullness sensation using a VAS questionnaire
Timepoint [2] 365877 0
VAS questionnaires will be completed at t = -2, 15, 30, 45, 60, 90, 120, 150 and 180 min.
Secondary outcome [3] 365884 0
Measure the desire to eat using a VAS questionnaire
Timepoint [3] 365884 0
VAS questionnaires will be completed at t = -2, 15, 30, 45, 60, 90, 120, 150 and 180 min.
Secondary outcome [4] 365885 0
Measure the amount of food the subject thinks he/she could eat
Timepoint [4] 365885 0
VAS questionnaires will be completed at t = -2, 15, 30, 45, 60, 90, 120, 150 and 180 min.

Eligibility
Key inclusion criteria
Healthy lean (BMI 19-25 kg/m2) male subjects aged between 18 - 55 years, non-smoker, and without significant illness will be included in the study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant gastrointestinal symptoms, disease or surgery;
Current gallbladder or pancreatic disease;
Cardiovascular or respiratory diseases;
Diagnosed type 2 diabetes;
Any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above);
Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, gastrointestinal function, body weight or appetite (eg domperidone, cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.);
Individuals with low ferritin (less than 30 ug/L) or iron (less than 8 umol/L) levels, or who have donated blood in the 12 weeks prior to taking part in the study;
Lactose intolerance/other food allergy(ies);
Vegetarians;
Current intake of greater than 2 standard drinks on greater than 5 days per week;
Current smokers of cigarettes/cigars/marijuana;
Current intake of any illicit substance;
High performance athletes;
Inability to comprehend study protocol;
Restrained eaters (score >12 on the three factor eating questionnaire).

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)
Eligible volunteers are assigned a subject number and randomised treatment for each study visit. Randomisation involves contacting the holder (study assistant) of the randomisation table to inform them of subjects details and study dates. The unblinded study assistant is therefore responsible for allocating a random treatment to the subject and preparing the study treatment on each study day.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation is generated using a randomization plan generator available at www.randomization.com
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/01/2019
Actual
1/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 301602 0
Government body
Name [1] 301602 0
National Health and Medical Research Council (NHMRC)
Country [1] 301602 0
Australia
Primary sponsor type
Individual
Name
Prof. Christine Feinle-Bisset
Address
School of Medicine, University of Adelaide
Level 5, Adelaide Health and Medical Sciences Building
Cnr North Terrace and George Street
Adelaide
South Australia 5005
Country
Australia
Secondary sponsor category [1] 301305 0
Individual
Name [1] 301305 0
Prof. Michael Horowitz
Address [1] 301305 0
School of Medicine, University of Adelaide
Level 5, Adelaide Health and Medical Sciences Building
Cnr North Terrace and George Street
Adelaide
South Australia 5005
Country [1] 301305 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302329 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 302329 0
Level 3, Roma Mitchell House, North Terrace, Adelaide SA 5000
Ethics committee country [1] 302329 0
Australia
Date submitted for ethics approval [1] 302329 0
01/05/2017
Approval date [1] 302329 0
18/05/2017
Ethics approval number [1] 302329 0
R20170501

Summary
Brief summary
To combat the global burden of obesity and its co-morbidities, a major challenge lies in the development of effective therapies that increase fullness and satiety, and result in improvements in blood glucose control, while lacking adverse effects that are often associated with current therapies.
Meal ingestion brings about changes in GI functions that are associated with slowing of gastric emptying, gut hormone release, regulation of blood glucose and energy intake. Among all three macro-nutrients, lipid seems to be the most potent. The effects of fat on gastric emptying, APD motility, gut hormones, energy intake, and blood glucose rely on fat digestion products, namely fatty acids, are an essential requirement for intestinal fat sensing.
Several studies have demonstrated effects of C12 on GI functions and energy intake. However, the effects of orally ingested C12 on the suppression of appetite over a period of time (for example, potential hunger-suppressant effects in the lead-up to meal ingestion), or its effects on gut hormones, gastric emptying of a meal and the relationship with postprandial blood glucose in both normal-weight and obese people remain unknown.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89842 0
Prof Christine Feinle-Bisset
Address 89842 0
School of Medicine, University of Adelaide
Level 5, Adelaide Health and Medical Sciences Building
Cnr North Terrace and George Street
Adelaide
South Australia 5005
Country 89842 0
Australia
Phone 89842 0
+61 8 8313 6053
Fax 89842 0
Email 89842 0
[email protected]
Contact person for public queries
Name 89843 0
Ms Penelope Fitzgerald
Address 89843 0
School of Medicine, University of Adelaide
Level 5, Adelaide Health and Medical Sciences Building
Cnr North Terrace and George Street
Adelaide
South Australia 5005
Country 89843 0
Australia
Phone 89843 0
+61 8 8313 6278
Fax 89843 0
Email 89843 0
[email protected]
Contact person for scientific queries
Name 89844 0
Prof Christine Feinle-Bisset
Address 89844 0
School of Medicine, University of Adelaide
Level 5, Adelaide Health and Medical Sciences Building
Cnr North Terrace and George Street
Adelaide
South Australia 5005
Country 89844 0
Australia
Phone 89844 0
+61 8 8313 6053
Fax 89844 0
Email 89844 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
In line with intellectual property agreement


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.