Effects of amino acids on gut functions in healthy lean individuals

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; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12620001275954
• Lead Sponsor: Prof. Christine Feinle-Bisset

Brief Summary

In healthy men, intraduodenal co-administration of increasing doses of Leu can interfere with the ability of Trp to stimulate the secretion of CCK, and pyloric pressures, possibly through changes in plasma Trp/LNAA ratio, associated with lesser suppression of energy intake.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-25
• Study Completion: 2023-03-01
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Lean (BMI: 19-25 kg/m2) male participants (aged 18-50 years) who are healthy and do not have chronic illnesses will be included.

Exclusion Criteria

- regular GI symptoms, as measured by the GI symptom score (score greater than 1 for any component) or significant GI disease or surgery
- use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, body weight or appetite (eg domperidone, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.), mood and cognitive function (including benzodiazepines (eg alprazolam), non-benzodiazepine (eg zolpidem), sedatives, antipsychotics (eg aripiprazole), and mood-stabilisers (eg lithium)
- regular medication that may affect any of the study outcomes (i.e. GI motor or hormone functions, appetite or mood) and cannot be discontinued during the study
- lactose intolerance/other food allergy
- current gallbladder or pancreatic disease
- coagulation abnormalities
- oesophageal varices or strictures
- cardiovascular or respiratory diseases that may affect any of the study outcomes and/or tolerance of the naso-duodenal tube
- psychological disorders, anxiety and depression, as assessed by the Kessler Psychological Distress Scale (K10)
- individuals with low serum ferritin levels (less than 30 µg/L), or who have donated blood in the 12 weeks prior to taking part in the study
- any other illnesses as assessed by the investigator (including chronic illnesses that may affect any of the study outcomes and not explicitly listed above)
- high performance athletes, due to their specific dietary requirements and energy intakes (i.e. much higher than the average population), which affect GI functions and appetite
- current intake of more than 2 standard drinks on more than 5 days per week, due to the known effects of alcohol on GI function, energy intake, mood and cognition
- current smokers/users of tobacco products (including pipe, chewing, cigarettes, cigars, sheesha, vaping etc)
- recreational drug use (e.g marijuana)
- current intake of any illicit substance (since all of these, i.e. tobacco products, marijuana and illicit drugs may affect both GI functions and mood.
- vegetarians
- restrained eaters (score greater than 12 on the 3-factor eating questionnaire)(the degree of eating restraint will be assessed in obese participants, but not used as an exclusion criterion, as obese often have some degree of eating restraint
- diabetes mellitus, as defined by fasting glucose greater than 6.9 mmol/l and/or HbA1c of greater than or equal to 6.5 or less than or equal to 7.9%
- inability to tolerate oro/naso-gastric tube
- inability to comprehend study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified