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Effects of intragastric administration of L-leucine, L-isoleucine and L-valine on gastric emptying, gut hormone release and blood glucose in healthy, lean volunteers.

Effects of intragastric administration of L-leucine, L-isoleucine and L-valine on gastric emptying, gut hormone release and blood glucose in healthy, lean volunteers.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000718145
Enrollment
15
Registered
2019-05-13
Start date
2019-05-30
Completion date
2019-12-16
Last updated
2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate the effects of intragastric administration of specific L-amino acids on gastric emptying, gut hormone release, glycaemic control and appetite perceptions in healthy, lean males. We hypothesize that the gastric emptying, gastrointestinal hormone, glycemic and appetite repsonses will be affected by specific L-amino acids in healthy lean males.

Interventions

Assessment of blood glucose and gastric emptying, following administration of control, 10g L-Leucine, 10g L-Isoleucine or 10g L-Valine 30 min prior to a standardised mixed nutrient drink. Subjects will receive, in randomized, double-blind fashion, a 100 ml intragastric bolus infusion of: i) 10g L-Leucine; ii) 10g L-Isoleucine; iii) 10g L-Valine; iv) saline (control). Subjects will receive one infusion per visit. All bolus infusions will be administered by the primary researcher. Study visits w

Assessment of blood glucose and gastric emptying, following administration of control, 10g L-Leucine, 10g L-Isoleucine or 10g L-Valine 30 min prior to a standardised mixed nutrient drink. Subjects will receive, in randomized, double-blind fashion, a 100 ml intragastric bolus infusion of: i) 10g L-Leucine; ii) 10g L-Isoleucine; iii) 10g L-Valine; iv) saline (control). Subjects will receive one infusion per visit. All bolus infusions will be administered by the primary researcher. Study visits will be separated by 3-7 days. In addition, during study visits, the primary researcher will be present in order to closely monitor adherence to study protocol. For each study visit a baseline blood sample, VAS, and breath sample will be collected (t = -31). At t = -31 the infusion will be administered over 1 minute using a feeding tube. At t = -20, -10, and -1 min further blood samples will be collected and VAS completed. At t = -1 min, subjects will consume, within 1 minute, a mixed-nutrient drink (Resource Plus, 500 kcal, 325 ml) labeled with 100 mg of 13C-acetate for measurement of gastric emptying by breath sampling, and 3g 3-OMG for measurement of glucose absorption. Blood samples and VAS will be taken every 15 minutes, and breath samples will be taken every 5 min, over the next hour (t = 0 to 60 min). Over the following hour, VAS and blood samples will be collected every half hour (t = 90, 120), and breath samples collected every 15 min (t = 75, 90, 105, 120).

Sponsors

Christine Feinle-Bisset
Lead SponsorIndividual

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

A total of 16 healthy, lean (BMI 19-25 kg/m2) male subjects, aged between 18 - 55 years will be included. Subjects will be required to be weight stable (ie <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 4 weeks.

Exclusion criteria

Significant gastrointestinal symptoms, disease or surgery; 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.) Lactose intolerance/other food allergy(ies) Current gallbladder or pancreatic disease Cardiovascular or respiratory diseases Those 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 Any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above) High performance athletes 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 Vegetarians Inability to comprehend study protocol Restrained eaters (score >12 on the three factor eating questionnaire)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026