Authors
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Massey University -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2020
INTERVENTION: Participants who habitually consume dairy and are self‐described as dairy tolerant will be recruited from the general population. Following informed consent, participants will be randomised to consume on a single morning either 500 mL ultra‐high temperature (UHT) bovine milk, or 500 mL pasteurised bovine milk (PAST) within 5 minutes. After a wash‐ out phase of minimum 3 days, the participants will cross over and receive the other treatment. CONDITION: Dairy intolerance;Digestive disorders; ; Dairy intolerance ; Digestive disorders Diet and Nutrition ‐ Other diet and nutrition disorders Oral and Gastrointestinal ‐ Normal oral and gastrointestinal development and function PRIMARY OUTCOME: Half gastric emptying time (T1/2) between UHT and PAST bovine milk ingestion as assessed by MRI.,[Gastric emptying T1/2 which will be determined from volumes captured at regular intervals after milk ingestion. At 5 minutes after milk ingestion, an MRI will be taken and from 10 minutes, every 10 minutes for half an hour. At 30 minutes after milk ingestion. MRI will be taken every 30 minutes till the T120 mark. Final scan will be conducted at T180.] SECONDARY OUTCOME: To investigate the difference in gastric emptying parameters between UHT and PAST, including TMAX, AUC, and CMAX [Mean difference between MRI scans, will be taken every 10 minutes for half an hour. At 30 minutes after milk ingestion. MRI will be taken every 30 minutes till the T120 mark. Final scan will be conducted at T180.] To investigate the differences in exploratory plasma metabolite changes between UHT and PAST milk after ingestion[Mean difference of blood response of plasma metabolites, as measured by HILIC / LC‐MS/MS / GC‐MS / NMR, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit] To investigate the differences in peripheral amino acid appearance changes between UHT and PAST milk after ingestion[Mean difference of blood response of peripheral amino acid appearance, as measured by HPLC, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit] To investigate the differences in peripheral B vitamin and vitamer appearance changes between UHT and PAST milk after ingestion[Mean difference of blood response of peripheral B vitamin and vitamer appearance, as measured by UPLC‐MS/MS collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit] To investigate the differences in peripheral fat soluble vitamin changes between UHT and PAST milk after ingestion ; ] To investigate the differences in physiological (body surface gastric mapping – BSGM) in response to UHT and PAST ingestion.[Mean difference of BSGM activity (as assessed using high resolution electrogastrography by cutaneously applied electrode arrays) continuously (aside from MRI scanning times) at each visit. ; ] To investigate the differences in physiological (plethysmography; abdominal distension) in response to UHT and PAST ingestion.[Mean difference of plethysmography (abdominal distension), as measured by stretch sensors and/or waist circumference, continuously (aside from MRI scanning times) at each visit ; ] To investigate the differences in plasma appetite hormone response to ingestion between UHT and PAST[Mean difference of blood responses of appetite hormones (including CCK, PYY, GLP‐1, and ghrelin), by immunoassays, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit] To investigate the differences in plasma glycaemic response to ingestion between UHT and PAST ; ] INCLUSION CRITERIA: a) Female adult (18‐40 years). Female participants will need to declare stage of menstrual cycle during the different study phases, if applicable. b) A BMI between 18 and 30 kg/m2. ; [Mean difference of blood response of peripheral fat soluble vitamin, as measured by LC‐MS/MS, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit] To investigate the differences in peripheral fatty acid appearance changes between UHT and PAST milk after ingestion[Mean difference of blood response of peripheral fatty acid appearance, as measured by GC‐FID / GC‐MS, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit] To investigate the differences in peripheral lipidome composition changes between UHT and PAST milk after ingestion[Mean difference of blood response of peripheral lipidome composition (including triglyceride responses), as measured by LC‐MS/MS, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit] To investigate the differences in peripheral mineral appearance c changes between UHT and PAST milk after ingestion[Mean difference of blood response of peripheral mineral appearance, as measured by ICP‐MS, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit ; [Mean difference of blood response of glucose and insulin, as measured by electrochemiluminescent and colorimetric assays, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit] To investigate the differences in subjective appetite responses between UHT and PAST.[Mean difference in appetite responses and digestive comfort using visual analog scales at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit ; ] To investigate the differences in subjective digestive responses between UHT and PAST.[Mean difference in subjective digestive comfort responses using visual analog scales at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit c) Self‐described habitual dairy consumer as assessed by average weekly liquid milk consumption of 3x 250 mL (1 glass). Can be consumed as a drink or as fluid milk in other forms (e.g. milk with tea, coffee, cereal, etc.)
Epistemonikos ID: b1c3c3b251be959ef0d629de9491f33daf935a5f
First added on: Aug 24, 2024