None listed
Conditions
Brief summary
A randomised, double-blind, crossover trial will investigate motility patterns, fermentation profiles, and symptom responses to varying lipid doses in 10 patients with functional dyspepsia – postprandial distress syndrome (FD-PDS) and 10 healthy controls. Participants will be randomly assigned in a crossover design manner to either ingest a low fat (3g), moderate fat (6g), or high fat (16 g) meal. This study aims to determine the effect of dietary lipid content on gastrointestinal transit times and regional fermentation gas dynamics (H2, CO2) in individuals with FD (PDS subtype) compared to healthy controls, using the Atmo gas-sensing capsule.
Interventions
Test meals with varying lipid doses as follows:
• Low-fat: 35 g oat-based cereal bar (Atmo Motility Bar) with 200 g of a modified yogurt containing 3 g saturated fat/serve and 240 mL water.
• Moderate-fat: 35 g oat-based cereal bar (Atmo Motility Bar) with 200 g of a modified yogurt containing 6 g saturated fat/serve and 240 mL water.
• High-fat: 35 g oat-based cereal bar (Atmo Motility Bar) with 200 g of a modified yogurt containing 16 g saturated fat/serve and 240 mL water.
Participants will
Test meals with varying lipid doses as follows: • Low-fat: 35 g oat-based cereal bar (Atmo Motility Bar) with 200 g of a modified yogurt containing 3 g saturated fat/serve and 240 mL water. • Moderate-fat: 35 g oat-based cereal bar (Atmo Motility Bar) with 200 g of a modified yogurt containing 6 g saturated fat/serve and 240 mL water. • High-fat: 35 g oat-based cereal bar (Atmo Motility Bar) with 200 g of a modified yogurt containing 16 g saturated fat/serve and 240 mL water. Participants will be asked to consume the test meals within 15 minutes under the supervision of a member of the research team (e.g., dietician/nutrition scientist). The Atmo Gas-Sensing capsule will be used to measure gastrointestinal transit time and fermentation profile in response to the test meals. As such, participants will then be asked to ingest the Atmo Gas-sensing capsule immediately after ingesting the test meal under the supervision of a member of the research team. Each study visit will be separated by a 3-day washout period wherein a member of the research team will monitor capsule excretion 24-48 h after each study visit.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
• Adults aged 18-65 years of age • Diagnosed with FD – PDS subtype (Rome IV criteria) by gastroenterologist or healthy controls • BMI greater than or equal to 18.5 kg/m2 and less than 30.0 kg/m2 • Ability to adhere to diet and capsules procedures • Ability to consent to study requirements • Sufficient English to provide informed consent and complete study questionnaires • Willing to abstain from restricted medications, supplements, and foods during the study periods (~1 month duration) • For females of childbearing potential: agreement to use highly effective contraception during the study • Symptomatic at the time of recruitment
Exclusion criteria
• Evidence of organic GI disease (e.g. peptic ulcer, coeliac disease, inflammatory bowel disease, GI malignancy) by history, investigation or recent endoscopy • Prior significant GI surgery (except appendectomy/cholecystectomy) • Severe comorbidities • Pregnancy/breastfeeding • Food allergies relevant to test meals • Inability to swallow capsule • Known gastroesophageal strictures, obstruction or swallowing disorders • Use of medications known to significantly affect gastrointestinal motility that cannot be safely withheld (e.g. prokinetics, laxatives, opioids, anticholinergics, antidiarrheals or proton pump inhibitors not withheld per protocol) • Commencement or change in dose of antibiotics, pre-, pro-, synbiotics or fibre supplements and digestive enzymes within 1 month prior to study • Recent participation in other studies involving intervention/measurements that may impact gastrointestinal motility (past 30 days) • Non-compliance with study procedures (e.g. inability to consume control diet and/or attend all three study visits) • Current smoker or history of smoking within the past 3 months prior to study • Positive Helicobacter pylori status • Significant loss of weight within the past 3 months prior to study • Other DGBI (e.g. IBS-C/D) or with functional constipation • Chronic intake of NSAIDS within the past 3 months prior to study • Patients with implantable or portable electro-mechanical medical devices (e.g., pacemakers) • Patients with GERD, diverticulitis, suspected obscure GI bleeding, gastric bezoar or radiation enteritis • Requiring an MRI during the study duration or 3 months after the study
Outcome results
None listed