Nutrient modulation of sensory responses of the human oesophagus
| ISRCTN | ISRCTN82131820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82131820 |
| Protocol serial number | N0217101260 |
| Sponsor | Department of Health (UK) |
| Funder | Salford Royal Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simon Lal
Scientific
Scientific
Gastroenterology
Clinical Sciences Building
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Nutrient modulation of sensory responses of the human oesophagus |
| Study objectives | To determine whether intragastric or intraduodenal infusion of cholecystokinin (CCK)-releasing fatty acid (C12 or C14) modifies the threshold at which sensations are experienced in response to different oesophageal stimuli, when compared to a non-CCK-releasing fatty acid (C10 or C8). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Sensory responses of the human oesophagus |
| Intervention | Extended pilot study consisting of a series of randomised controlled studies. |
| Intervention type | Other |
| Primary outcome measure(s) |
To confirm or refute the hypothesis that fatty acids have a differential effect on oesophageal sensations. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2004 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | Healthy male or female volunteers aged 20 - 60 years |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/2001 |
| Date of final enrolment | 31/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hope Hospital
Salford
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/02/2018: No publications found, verifying study status with principal investigator.
