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Biogut: a study of nutrient bioaccessibility in ileostomy volunteers

A randomised trial to study nutrient bioaccessibility in ileostomy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40517475
Enrollment
12
Registered
2012-06-13
Start date
2012-09-03
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Digestion and nutrient bioaccessibility Digestive System

Interventions

Participants will eat on 5 separate occasions the test meals rich in either fat (Study 1) or starch (Study 2): Study 1 (3 visits) 1. 85 g of whole almonds given with a muffin and some custard 2. A m

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female aged 20-60 years, who previously had proctocolectomy 2. Stable at least 12 months post-operative 3. Normal stoma functions (digest and excrete food without any difficulty)

Exclusion criteria

Exclusion criteria: 1. Allergy to almonds or related products, gluten and any other added ingredients in recipe of the test meal 2. Previous case of obstruction of the stoma 3. Body mass index 35 kg/m2 4. Have a diagnosed mouth, throat or gastrointestinal tract problem (other than ileostomy) that may affect normal ingestion and digestion of food 5. Plasma glucose > 7 mmol/L 6. Plasma cholesterol > 7.8 mmol/L 7. Plasma triacylglycerol > 3 mmol/L 8. On a medication regimen that would invalidate the results as judged by the medical advisor

Design outcomes

Primary

MeasureTime frame
Indicative measure of the digestibility (nutrient loss and modification in cell wall structure) of fat or starch foods during passage throught the upper gastrointestinal tract

Secondary

MeasureTime frame
1. Measuring the glycaemic and lipaemic response to the test meals including insulin and c-peptide 2. Measuring the particle size of chewed and digested samples 3. Examination of the microstructure of chewed and digested samples 4. Measuring gut hormones [peptide YY (PYY), cholecystokinin (CCK), glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP)] For Study 1, plasma triacylglycerol concentrations will be measured hourly up to 8 h to determine the overall level of lipaemia after eating the test meal. Plasma glucose and insulin will also be measured at 0, 15, 30, 45, 60, 90, and 120 min and thereafter at 3, 4, 5, 6, 7, and 8 h. For Study 1 and 2, plasma glucose and insulin concentrations will be measured at 0, 15, 30, 45, 60, 90, 120, 150 min and at hourly intervals up to 4 h, to determine blood glucose and insulin levels after eating the test meal.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026