None listed
Conditions
Brief summary
To combat the global burden of obesity and its co-morbidities, a major challenge lies in the development of effective therapies that increase fullness and satiety, and result in improvements in blood glucose control, while lacking adverse effects that are often associated with current therapies. Meal ingestion brings about changes in GI functions that are associated with slowing of gastric emptying, gut hormone release, regulation of blood glucose and energy intake. Among all three macro-nutrients, lipid seems to be the most potent. The effects of fat on gastric emptying, APD motility, gut hormones, energy intake, and blood glucose rely on fat digestion products, namely fatty acids, are an essential requirement for intestinal fat sensing. Several studies have demonstrated effects of C12 on GI functions and energy intake. However, the effects of orally ingested C12 on the suppression of appetite over a period of time (for example, potential hunger-suppressant effects in the lead-up to meal ingestion), or its effects on gut hormones, gastric emptying of a meal and the relationship with postprandial blood glucose in both normal-weight and obese people remain unknown.
Interventions
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 performe
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.
Sponsors
Prof. Christine Feinle-Bisset
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Exclusion criteria
Significant gastrointestinal symptoms, disease or surgery; Current gallbladder or pancreatic disease; Cardiovascular or respiratory diseases; Diagnosed type 2 diabetes; Any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above); Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, gastrointestinal function, body weight or appetite (eg domperidone, cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.); Individuals with low ferritin (less than 30 ug/L) or iron (less than 8 umol/L) levels, or who have donated blood in the 12 weeks prior to taking part in the study; Lactose intolerance/other food allergy(ies); Vegetarians; Current intake of greater than 2 standard drinks on greater than 5 days per week; Current smokers of cigarettes/cigars/marijuana; Current intake of any illicit substance; High performance athletes; Inability to comprehend study protocol; Restrained eaters (score >12 on the three factor eating questionnaire).
Outcome results
None listed