Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000543583
Ethics application status
Approved
Date submitted
17/04/2024
Date registered
30/04/2024
Date last updated
11/08/2024
Date data sharing statement initially provided
30/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of calcium on gut hormone secretion in healthy participants
Scientific title
Effects of intraduodenal calcium on the release of gut hormone, upper gastrointestinal motility, and energy intake in healthy participants
Secondary ID [1] 311923 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy human gastrointestinal physiology 333510 0
Healthy human bone turnover physiology 333633 0
Condition category
Condition code
Diet and Nutrition 330188 330188 0 0
Obesity
Oral and Gastrointestinal 330189 330189 0 0
Normal oral and gastrointestinal development and function
Metabolic and Endocrine 330190 330190 0 0
Normal metabolism and endocrine development and function
Musculoskeletal 330191 330191 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study consists of a 75-min intraduodenal infusion of either a calcium chloride (CaCl2) or control solution.

Participants enrolled into the study will receive, in randomised, double-blind fashion
(i) Saline (control),
(ii) 500 mg CaCl2,
(iii) 1000 mg CaCl2,

each occurring at separate visits. Each visit will last 4-6 hours in duration and will be separated by 3-7 days. To ensure adherence to the intervention, research staff will closely supervise the participants throughout the study visit. Visits will be carried out in the Clinical Research Facility of the Adelaide Medical School, the University of Adelaide by staff and students trained in the required techniques.

Participants will be asked to consume a standardised dinner meal (Beef lasagne; total energy content: 602kcal; McCain Food, Wendouree, Victoria, Australia) the night before each visit by no later than 7 pm. After fasting for 14 hours overnight and refraining from exercise and alcohol for 24 hours, participants will arrive at the laboratory at 8 am. Upon arrival, participants will be intubated with a 17-channel manometric catheter that will be inserted through an anaesthetised nostril and allowed to pass through the stomach and into the duodenum by peristalsis. The manometric catheter consists of 16 side holes, spaced at 1.5 cm intervals, will be used for measuring pressures in the antrum, pylorus, and duodenum. An additional channel (with the side hole positioned approx 14 cm distal to the pylorus when the catheter is in the correct position) will be used for intraduodenal infusions. The correct positioning of the catheter will be maintained by continuous measurement of the transmucosal potential difference between the most distal antral channel and the most proximal duodenal channel. All manometric channels will be perfused with degassed, distilled water, except for the two channels that will be perfused with degassed 0.9% saline, at 0.15 ml/min. An intravenous cannula will be placed into a forearm vein for regular blood sampling. Once the catheter has been positioned correctly, fasting motility will be monitored continuously, and immediately after the end of phase III activity of the fasting migrating motor complex, during a period of motor quiescence, baseline antropyloroduodenal (APD) pressures will be recorded for 10 min (t = -10-0 min), and at t = 0 min after collecting baseline blood sample and visual analogue scale (VAS), one of the three intraduodenal infusions (ie i) saline, ii) 500 mg or iii) 1000 mg CaCl2) will commence.

APD pressures will be measured continuously for 75 min (t = 0-75 min). Vital signs (blood pressure, heart rate) will be measured at regular time intervals using a sphygmomanometer/blood pressure meter. At t = 75 min, the manometric assembly will be removed and participants will be presented with a standardised, buffet-style meal to assess energy intake. Participants will be allowed 30 min to freely consume food until they feel comfortably full. At t = 105 min, a final blood sample and VAS questionnaire will be collected. The intravenous cannula will then be removed and participants will be allowed to leave the laboratory. A total of 80 mL of blood will be taken on each study day (study total of 248 mL, including screening test).
Intervention code [1] 328388 0
Treatment: Other
Comparator / control treatment
Saline
Control group
Placebo

Outcomes
Primary outcome [1] 337942 0
Energy intake at a buffet meal
Timepoint [1] 337942 0
At t=75 min, participants will be presented with a standardised, buffet-style meal, to assess energy intake. The meal comprises 4 slices (~120 g) of whole-meal bread, 4 slices (~120 g) of white bread, 100 g sliced ham, 100 g sliced chicken, 85 g sliced cheddar cheese, 100 g lettuce, 100 g sliced tomato, 100 g sliced cucumber, 22 g mayonnaise, 20 g margarine, 1 apple (~170 g), 1 banana (~190 g), 175 g strawberry yogurt, 100 g chocolate custard, 120 g fruit salad, 375 mL iced coffee, 300 mL orange juice, and 600 mL water. The meal has a total energy content of ~2300 kcal (~27% fat, ~52% carbohydrate, and ~21% protein) and weight of ~2924 g.
Secondary outcome [1] 433831 0
Plasma concentrations of GI hormones (including cholecystokinin (CCK), glucagon-like peptide-1 (GLP-1), peptide tyrosine-tyrosine (PYY), and potentially other yet to be discovered hormones, will be assessed as a composite secondary outcome.
Timepoint [1] 433831 0
These will be assessed from venous blood samples taken at regular time points during the infusion (t= 0, 5, 15, 30, 45, 60, 75 min) and after the meal (t = 105 min).
Secondary outcome [2] 433834 0
Antropyloroduodenal (APD) pressures
Timepoint [2] 433834 0
This will be measured continuously from t = -10-75 min using the manometric catheter.
Secondary outcome [3] 434147 0
Appetite ratings (hunger, fullness, desire to eat, and prospective consumption), and GI symptoms (nausea and bloating) will be assessed as a composite secondary outcome.
Timepoint [3] 434147 0
These will be assessed at regular time points during the infusion (t= 0, 5, 15, 30, 45, 60, 75 min) and after the meal (t = 105 min).

Eligibility
Key inclusion criteria
Healthy
Lean weight (BMI 19-25 kg/m2)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Each participant will be questioned prior to the study to exclude:
• significant GI symptoms, disease or surgery
• use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, body weight or appetite (e.g. domperidone, cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
• lactose intolerance/other food allergy(ies)
• current gallbladder or pancreatic disease
• cardiovascular or respiratory diseases
• individuals with low ferritin levels (females <15 ng/mL, males <30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
• any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above)
• high performance athletes
• current intake of > 2 standard drinks on > 5 days per week
• current smokers of tobacco (cigarettes, cigars, pipes, sheesha, chewing, vaping etc.)
• recreational drug use, e.g marijuana
• current intake of any illicit substance
• vegetarians
• inability to tolerate nasoduodenal tube
• inability to comprehend study protocol
• restrained eaters (score >12 on the 3-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 participant number and randomised treatment for each study visit. Randomisation involves contacting the holder (study assistant) of the randomisation table to inform them of participant details and study dates. The unblinded study assistant is, therefore, responsible for allocating a random treatment to the participant and administering the dose.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation is generated using a 3x3 Latin Square design, with subjects randomly allocated to one of three treatment sequences. Randomisation using blocks of size 3 will be generated with sealedenvelope.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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
31/05/2024
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
15/05/2025
Actual
Sample size
Target
15
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316268 0
Government body
Name [1] 316268 0
National Health and Medical Research Council (NHMRC)
Country [1] 316268 0
Australia
Primary sponsor type
Individual
Name
Christine Feinle-Bisset
Address
Country
Australia
Secondary sponsor category [1] 318457 0
Individual
Name [1] 318457 0
Michael Horowitz
Address [1] 318457 0
Country [1] 318457 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315088 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315088 0
Ethics committee country [1] 315088 0
Australia
Date submitted for ethics approval [1] 315088 0
20/03/2022
Approval date [1] 315088 0
20/04/2022
Ethics approval number [1] 315088 0
13243

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

Contacts
Principal investigator
Name 133638 0
Prof Christine Feinle-Bisset
Address 133638 0
Adelaide Medical School University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
Country 133638 0
Australia
Phone 133638 0
+61 8 8313 6053
Fax 133638 0
Email 133638 0
[email protected]
Contact person for public queries
Name 133639 0
Prof Christine Feinle-Bisset
Address 133639 0
Adelaide Medical School University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
Country 133639 0
Australia
Phone 133639 0
+61 8 8313 6053
Fax 133639 0
Email 133639 0
[email protected]
Contact person for scientific queries
Name 133640 0
Prof Christine Feinle-Bisset
Address 133640 0
Adelaide Medical School University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
Country 133640 0
Australia
Phone 133640 0
+61 8 8313 6053
Fax 133640 0
Email 133640 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.