Effects of fat and protein ‘pre-loads’ on Gastric Emptying, Small Intestine transit, gut hormones, glycaemia, plasma insulin, haemodynamics, absorption, appetite and Gastrointestinal symptoms in response to a mixed meal after Roux-en-Y Gastric Bypass

Effects of fat and protein ‘pre-loads’ on GE, SI transit, gut hormones, glycaemia, plasma insulin, haemodynamics, absorption, appetite and GI symptoms in response to a mixed meal after RYGB

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000718741

Enrollment

Registered

2013-07-01

Start date

2010-12-03

Completion date

2012-12-17

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

The current study aims to examine the effects of protein and fat ‘preloads’ of RYGB on GE or SI transit, appetite-related and incretin hormones, GI symptoms and haemodynamics. We hypothesized that when given before a mixed meal, (A) a fat ‘preload’ has no effect on GE but slows SI transit, increases the GLP-1 and PYY responses, reduces glycaemic and insulin responses and attenuates the fall in BP and rises in HR/SMA blood flow, as well as symptoms; and (B) a protein ‘preload’ has no effect on GE but slows SI transit, increases GLP-1 and PYY responses, reduces the glycaemic but increases the insulin response and attenuates the fall in BP and rises in HR/SMA flow and symptoms.

Interventions

Twenty morbidly obese subjects will be studied on 3 occasions, which are separated by at least 4 weeks. The subjects will be randomised into 3 “pre-load” groups, in which they will consume either a control of 30ml of water, or one of two preloads, either 30ml olive oil, or 55g Whey protein (in 100ml soup), 30min before a 50g beef patty meal. the preload is administered at t= -30min and the beef patty at t=0

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Subjects who have had have had RYGB (Roux-en-Y Gastric Bypass) RYGB was performed for at least 6 months ago

Exclusion criteria

Subjects with a history of severe respiratory, cardiovascular, hepatic and/or renal disease, chronic alcohol abuse or epilepsy (excluded by history) Subjects requiring medication that may influence gastrointestinal function No previous history of surgery to the gastrointestinal tract apart from the RYGB or LAGB Subjects who have been exposed to ionising radiation for research purposes in the past 12 months Female patients not using appropriate contraceptive method (ie oral contraceptive pill, diaphragm, Depo-Provera hormonal contraceptive injection, intrauterine device (IUD), Norplant method) Pregnancy and/or breastfeeding mothers Smoking > 10 cigarettes/day Alcohol consumption > 20 g/day

Outcome results