Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/09/2010
Date assigned
25/11/2010
Last edited
12/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julie Wallace

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REC/10/0013

Study information

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

Acronym

Study hypothesis

Consumption of slow carbohydrate digestion will influence satiety, related blood biomarkers of satiety and energy release, and subsequent food intake

Ethics approval

The University of Ulster Research Ethics Committee approved on the 23rd of May 2010 (REC/10/0013)

Study design

Randomised double blind crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2010

Overall trial end date

31/01/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

38

Participant exclusion criteria

1. Regular use of medication (apart from OTC medication)
2. Smoking

Recruitment start date

01/06/2010

Recruitment end date

31/01/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Ulster (UK)

Sponsor details

Cromore Road
Coleraine
BT52 1SA
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Nestle (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes