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
Protocol serial number	REC/10/0013
Sponsor	University of Ulster (UK)
Funder	Nestle (UK)

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

Northern Ireland Centre for Food and Health
University of Ulster
Coleraine
BT52 1SA
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised double blind crossover group trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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)
Completion date	31/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
Northern Ireland

Study participating centre

Northern Ireland Centre for Food and Health

Coleraine
BT52 1SA
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