Effects of intragastric administration of L-phenylalanine on gastric emptying, gut hormone release, blood glucose and energy intake in healthy, normal weight subjects.

Not Applicable

Completed

• Conditions: Obesity; Type 2 diabetes; Healthy human gastrointestinal physiology; Diet and Nutrition - Obesity; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616001595404
• Lead Sponsor: Christine Feinle-Bisset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-18
• Study Completion: 2019-04-05
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

A total of 16 healthy, lean (BMI 19-25 kg/m2) male subjects, aged between 18 - 55 years, will be included in each study part.

Exclusion Criteria

Significant gastrointestinal symptoms, disease or surgery;
Current gallbladder or pancreatic disease;
Cardiovascular or respiratory diseases;
Phenylketonuria; .
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 and cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.);
Individuals with low ferritin levels (less than 30 ng/mL), 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;
Restrained eaters (score >12 on the three factor eating questionnaire);
Inability to comprehend study protocol;
Unable to tolerate naso-gastric tube.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part A:<br>Energy intake at the buffet meal measured using the computer software program FoodWorks.<br><br>[Part A:<br>A buffet meal will be presented during each study visit (t = 0-30). The subject will be allowed to freely consume food until comfortably full for 30 minutes.<br><br><br>];Part B:<br>Blood glucose before and after infusion administration, and following the mixed nutrient Ensure drink.[Part B:<br>Blood glucose will be assessed from blood samples taken at t = -31, -20, -10, -1, 15, 30, 45, 60, 90, 120 min, where t = -31 is just prior to the time of L-phenylalanine administration and t = -1 is just prior to nutrient drink consumption.]