Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2019
INTERVENTION: 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. CONDITION: Diet and Nutrition ‐ Obesity Metabolic and Endocrine ‐ Diabetes Obesity;Type 2 diabetes ;Healthy Human Gastrointestinal Physiology; ; Obesity ; Type 2 diabetes; ; Healthy Human Gastrointestinal Physiology Oral and Gastrointestinal ‐ Normal oral and gastrointestinal development and function PRIMARY OUTCOME: 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.[Plasma will be obtained from blood samples taken at t = ‐2, 15, 30, 45, 60, 90, 120, 150, and 180 min.] SECONDARY OUTCOME: Measure fullness sensation using a VAS questionnaire[VAS questionnaires will be completed at t = ‐2, 15, 30, 45, 60, 90, 120, 150 and 180 min.] Measure hunger sensation using a VAS questionnaire[VAS questionnaires will be completed at t = ‐2, 15, 30, 45, 60, 90, 120, 150 and 180 min.] Measure the amount of food the subject thinks he/she could eat[VAS questionnaires will be completed at t = ‐2, 15, 30, 45, 60, 90, 120, 150 and 180 min.] Measure the desire to eat using a VAS questionnaire[VAS questionnaires will be completed at t = ‐2, 15, 30, 45, 60, 90, 120, 150 and 180 min.] 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.
Epistemonikos ID: 0398e93c6221b0a6f8ed902a0be9cd756fc75a9d
First added on: Aug 24, 2024