Investigation of the effects of slow release carbohydrate digestion on satiety and related blood biomarkers of satiety and energy release
| ISRCTN | ISRCTN46403895 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46403895 |
| Secondary identifying numbers | REC/10/0013 |
- Submission date
- 28/09/2010
- Registration date
- 25/11/2010
- Last edited
- 12/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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 Julie Wallace
Scientific
Scientific
Northern Ireland Centre for Food and Health
University of Ulster
Coleraine
BT52 1SA
United Kingdom
Study information
| Study design | Randomised double blind crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Investigation of the effects of slow release carbohydrate digestion on satiety and related blood biomarkers of satiety and energy release: A randomised, double blinded, crossover trial |
| Study objectives | Consumption of slow carbohydrate digestion will influence satiety, related blood biomarkers of satiety and energy release, and subsequent food intake |
| Ethics approval(s) | The University of Ulster Research Ethics Committee approved on the 23rd of May 2010 (REC/10/0013) |
| Health condition(s) or problem(s) studied | Food metabolism |
| Intervention | Each patient will undergo each of the following conditions on the same day of each week and with a minimum one week interval between study conditions: 1. Control (rapidly digestible starches) 2. 10g slow digestible starch 3. 25g slow digestible starch The order in which the patient undergoes these conditions will be randomised. |
| Intervention type | Other |
| Primary outcome measure | Food and nutrient intake: 1. Energy intake (kJ) 2. Macronutrient intakes (g and % energy) 3. Weight of food and beverages (g) consumed Assessed following a test meal served 4 hours after consuming each of the test products. |
| Secondary outcome measures | 1. Subjective satiety ratings: Visual analogue scales (VAS) to assess feelings of hunger, fullness, thirst, preoccupation with thoughts of food and desire to eat will be made on each study condition 2. Hormonal and metabolic responses: Blood samples will be taken at each study condition by venous cannula and analysed for the following metabolites: 2.1. Glucose 2.2. Insulin 2.3. Glucagon-Like Peptide (GLP-1) 2.4. Ghrelin 2.5. Peptide YY (PYY) (GLP-1, Ghrelin, and PYY only being analysed if there is a positive outcome for the outer measures) |
| Overall study start date | 01/06/2010 |
| Completion date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 38 |
| Key inclusion criteria | 1. Aged between 19-55 years 2. Body Mass Index (BMI) > 20 and < 25 3. In good health condition (no cardiovascular, respiratory, neurological or metabolic disease such as diabetes) 4. Willing to consume the test products |
| Key exclusion criteria | 1. Regular use of medication (apart from OTC medication) 2. Smoking |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 31/01/2011 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Northern Ireland Centre for Food and Health
Coleraine
BT52 1SA
United Kingdom
BT52 1SA
United Kingdom
Sponsor information
University of Ulster (UK)
University/education
University/education
Cromore Road
Coleraine
BT52 1SA
Northern Ireland
United Kingdom
"ROR" |
https://ror.org/01yp9g959 |
|---|
Funders
Funder type
Industry
Nestle (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
