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Contribution of the level of protein hydrolysis to the effects of small intestinal protein, on gut motility, gut hormone release and sensations of appetite.

Contribution of the level of protein hydrolysis to the effects of intraduodenal protein, on antropyloroduodenal motility, gut hormone release and sensations of appetite in lean and obese males.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000364077
Enrollment
32
Registered
2010-05-07
Start date
2010-01-14
Completion date
Unknown
Last updated
2020-01-13

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 has been designed to investigate how the extent of hydrolysated protein effects gut motility, gut hormones and appetite sensations. Volunteers are required to visit the clinic on 3 occassions no less than 3 days apart. Visits will last for approximately 5 hours. A long flexible tube will be inserted through an anaesthetised nostril and passed through into the small intestine to monitor stomach and small intestinal contractions. Through this tube, a protein solution will be infused into the small intestine over a 90 minute period. Blood samples will be taken (through a cannula, which is a long flexible tube inserted into a vein) and questionnaires on appetite sensations will be completed every 15 minutes. At the end of the 90 minute solution infusion, a buffet meal will be provided. This meal will be consumed over 30 minutes until the volunteer is confortably full.

Interventions

A single, 90 minute, 3kcal/min ( 270kcal total load) intraduodenal infusion of each of the following treatments in random order: a) Intact Whey Protein, b) 18% Whey Protein Hydrosylate, or c) free amino acid solution. Appetite sensation questionnaires (VAS) and blood samples will occur at t= -15 min, 0 (start of infusion), 15, 30, 45, 60, 75, 90 & 120 (after completion of the buffet meal). A buffet meal will be provided at the end of infusion and the participant has 30 minutes to eat until comfo

A single, 90 minute, 3kcal/min ( 270kcal total load) intraduodenal infusion of each of the following treatments in random order: a) Intact Whey Protein, b) 18% Whey Protein Hydrosylate, or c) free amino acid solution. Appetite sensation questionnaires (VAS) and blood samples will occur at t= -15 min, 0 (start of infusion), 15, 30, 45, 60, 75, 90 & 120 (after completion of the buffet meal). A buffet meal will be provided at the end of infusion and the participant has 30 minutes to eat until comfortably full. The buffet meal consists of 300ml orange juice, 600ml water, 375ml iced coffee, 4 slices white bread, 4 slices brown bread, 100g deli leg ham, 100g virginian chicken, 4 slices cheese, 100g tomato, 100g cucumber, 100g lettuce, 2 portions manyonnaise, 2 portions margarine, 1 medium apple, 1 medium banana, 200g chocolate custard, 150g fruit salad, 200g strawberry yoghurt, and 14g milky way chocolate bar. Each volunteer will receive one of each infusion solutions on each of the 3 study days. Each study visit will be separated by no less than 3 days and no more than 10 days.

Sponsors

Christine Feinle-Bisset
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

non-obese with a Body Mass Index (BMI) of 18-25 kg/m2 and obese with a BMI of 27-35 kg/m2 Weight stable (<5% fluctuation in body weight in previous 3 months)

Exclusion criteria

Significant gastrointestinal symptoms, disease or surgery. Use of prescribed or non-prescribed medications (including vitamins and herbal suppliments) 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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026