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Gastrointestinal determinants of vascular risk in healthy humans

A randomised crossover trial of the effect of adding guar gum to meals or prolonging meal duration on postprandial flow mediated dilatation in healthy humans

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000828628
Enrollment
12
Registered
2014-08-05
Start date
2012-07-17
Completion date
2013-05-31
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 aim of the trial is to examine the hypothesis that dietary interventions, which slow gastric emptying and/or the rate of carbohydrate absorption, will be associated with a corresponding reduction in the decline in endothelial dysfunction that is observed after meals. Subjects will be studied on 3 occasions in random order, after an overnight fast. They will consume a 13C-octanoic acid labelled mashed potato meal ('meal 1'), or the same meal mixed with 9 g guar ('meal 2') within 10 min, or 'meal 1' divided into 12 equal portions over 60 min ('meal 3'). Brachial artery flow mediated dilatation will be measured every 30 min for 120 min, breath samples will be collected to evaluate gastric emptying, and blood will be sampled to measure blood glucose and serum insulin.

Interventions

Each of 3 meals will be administered once, with at least 2 days between each. For 'meal 1', the mashed potato meal will be consumed over 10 min. For 'meal 2', 9g guar gum will be added to the mashed potato meal, and consumed over 10 min. For 'meal 3', the mashed potato meal will be consumed over 60 min.

Sponsors

University of Adelaide
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy volunteers

Exclusion criteria

History of gastrointestinal surgery (except appendicectomy) History of cerebral haemorrhage or head trauma Hypertrophic obstructive cardiomyopathy, or aortic or mitral valve stenosis Medication which may affect gastrointestinal motor function or phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, or vardenafil) Other significant illness, including epilepsy, cardiovascular or respiratory disease Evidence of drug abuse, consumption of more than 20 g alcohol on a daily basis, or smoking.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026