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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000376044

Enrollment

Registered

2010-05-11

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 load and duration of Whey Protein Hydrolysate effects gut motility, gut hormones, and appetite sensations. Volunteers are required to visit the clinic on 4 occassions no less than 3 days apart. Visits will last for approximately 5 hours. A long felxible tube will be inserted through an anaethetised nostril and passed through into the small intestine to monitor stomach and small intestinal contractions. Through this tube, a whey protein or saline solution will be infused over a 60 minute period (4mL/min). 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 60 minute infusion, a buffet meal will be provided. This meal will be consumed over 30 minutes until the volunteer is comfortably full.

Interventions

A single 60 minute intraduodenal infusion at 4mL/min of: a) 0 kcal/min (control of saline solution ) b) 0.5 kcal/min (Whey Protein Hydrolysate) c) 1.5 kcal/min (Whey Protein Hydrolysate) d) 3.0 kcal/min (Whey Protein Hydrolysate) Appetite sensation questionnaires in the form of a Visual Analogue Scale (VAS), blood samples. 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 mayonnaise, 2 portions margarine, 1 medium apple, 1 medium banana, 200g chocolate custard, 150g fruit salad, 200g strawberry yoghurt, and a 14g milky way chocolate bar. Each volunteer will receive one of each infusion solutions on each of the 4 study days. Each study visit will be separated by no less than 3 days. Each study visit will last approximately 3-6 hours.

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 18-25kg/m2 and obese with a BMI of 27-35kg/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 effect 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