None listed
Conditions
Brief summary
A novel medical device, the Atmo gas-sensing capsule, has emerged as a technique capable of reliably assessing regional gastrointestinal transit time. In order to standardise assessments made using the Atmo gas-sensing capsule, the meal that is eaten as part of the investigation needs to be consistent across assessments. An alternative nutrient bar has been developed for this purpose to approximate the nutrition profile and form of a predicate nutrient bar. This study aims to compare how the two nutrient bars impact regional gastrointestinal transit time, to determine whether the newly developed, alternative nutrient bar is suitable for future evaluations of transit time using the Atmo gas-sensing capsule.
Interventions
This study will involve consumption of two nutrient bars (alternative and predicate) on separate occasions. These bars are matched for serve size (~70 g) and nutritional composition (~1050 kJ, ~15 g protein, ~2 g fat, ~45 g carbohydrate), but differ in their ingredient profiles and in the proprietary processes by which they are manufactured. A medical device, the Atmo gas-sensing capsule, will be ingested immediately afterward, on each occasion.
Following an overnight fast (water only for at le
This study will involve consumption of two nutrient bars (alternative and predicate) on separate occasions. These bars are matched for serve size (~70 g) and nutritional composition (~1050 kJ, ~15 g protein, ~2 g fat, ~45 g carbohydrate), but differ in their ingredient profiles and in the proprietary processes by which they are manufactured. A medical device, the Atmo gas-sensing capsule, will be ingested immediately afterward, on each occasion. Following an overnight fast (water only for at least 8 hours), participants will attend the Department of Gastroenterology at the Alfred Centre to undertake the investigation. Participants will be asked to consume the alternative nutrient bar with 200 mL water within a 15 min timeframe, followed immediately by ingestion of the Atmo gas-sensing capsule. Participants will fast for the next 6 hours, and consume their normal meals thereafter. Participants will be monitored for 15 minutes before being able to leave the trial site. Once ingested, the Atmo gas-sensing capsule transmits information about gas profiles (hydrogen, carbon dioxide etc.) and temperature every 5 minutes to an external receiver worn by the participant. Data recording will then be ceased once the capsule has been passed (confirmed visually in the toilet bowl or signal loss after a bowel movement) from the body. The Atmo gas-sensing capsule is a simple, safe and non-invasive method for learning about the inside of the bowel. As a crossover trial, participants will undertake both treatments. The treatments will be delivered by a research dietitian from the Department of Gastroenterology. There is no minimum wash out period between treatments, although confirmation of the first capsule's excretion is required prior to the undertaking the second treatment. Participants will be required to attend the trial site (Department of Gastroenterology at the Alfred Centre) once per treatment; each visit will take approximately 30 minutes.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy individuals
Exclusion criteria
- Presence or suspicion of gastrointestinal or chronic comorbidity (e.g., irritable bowel syndrome, chronic kidney disease). - Have had previous abdominal surgery. - Has an implantable device (e.g., pacemaker). - Dysphagia to solid foods. - Use of antibiotic therapies in the month preceding study commencement. - Consumption of prebiotics and probiotics in the month preceding study commencement. - Use of medication that potentially affects gastrointestinal transit time (e.g.,hypomotility agents, laxatives). - Pregnancy or planning pregnancy. - Current smoker. - Unable to give written informed consent.
Outcome results
None listed