Measurement of the glycaemic index (GI) of an enteral nutrition formulation in healthy subjects
Organizational Data
- DRKS-ID:
- DRKS00029379
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-08-18
- Last update in DRKS:
- 2022-12-06
- Registration type:
- Retrospective
Acronym/abbreviation of the study
GCOS-010-CEN
URL of the study
No Entry
Brief summary in lay language
In this study the effect of an enteral nutrition formulation on blood glucose levels is measured (determination of the glycaemic index, GI)
Brief summary in scientific language
The glycemic index of an enteral nutrition formulation (sip and tube feed) will be determined in this study. The study will be performed according to ISO 26642:2010. The test product will be compared with glucose dissolved in water as reference. The orally administered volume of product contains a comparable amount of available carbohydrates. Each subject will test the test product once and the reference product three times on separate days, with at least a one-day wash-out between measurements. Subjects will be tested in the morning after a 10-12 hour overnight fast. Participants will act as their own controls
Health condition or problem studied
- Free text:
- Healthy subjects
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Diben POWDER (Vanille), once p.o., volume containing 25 g or 50g available carbohydrates (depending on results of nutrient analysis)
- Arm 2:
- Glucose, 25 g oder 50 g p.o. on 3 separate days. Participants will act as their own controls
Endpoints
- Primary outcome:
- Glycaemic index (GI). Blood samples will be taken at -5 min and 0 min before consumption of the product and the baseline value taken as a mean of these two values. The product will be consumed immediately after this within 15 minutes and further blood samples will be taken at 15, 30, 45, 60, 90 and 120 minutes after starting to eat/drink. Additional blood samples will be taken at 150 and 180 minutes for a 3-hour test.
- Secondary outcome:
- n.a.
Study Design
- Purpose:
- Basic research/physiological study
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Crossover
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- United Kingdom
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Oxford Brookes Centre for Nutrition and Health (OxBCNH), Department of Sport, Health Sciences & Social Work, Oxford Brookes University, Gipsy Lane Campus, Headington Oxford OX3 0BP
Recruitment period and number of participants
- Planned study start date:
- 2022-08-30
- Actual study start date:
- 2022-08-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2022-09-15
- Target Sample Size:
- 10
- Final Sample Size:
- 12
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 60 Years
- Additional Inclusion Criteria:
- Healthy subjects who give informed consent to participate in the study and fulfill the eligibility criteria according to ISO 26642
Exclusion Criteria
- Aged < 18 or > 60 years; - Pregnant or lactating; - Body mass index (BMI) > 30 kg/m2; - Known history of diabetes mellitus or fasting blood glucose value > 6.1 mmol/l or the use of anti-hyperglycaemic drugs or insulin to treat diabetes and related conditions; - Any known food allergy or intolerance; - Medical condition(s) or medication(s) known to affect glucose regulation, tolerance or appetite and/or which influence digestion and absorption of nutrients (excluding oral contraceptives); - Major medical or surgical event requiring hospitalization within the preceding 3 months; - Use of steroids, protease inhibitors, amphetamines or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution); - Participants who are unable to comply with experimental procedures or do not follow GI testing safety guidelines
Addresses
Primary Sponsor
- Address:
- Fresenius Kabi Deutschland GmbHElse-Kröner-Straße 161352 Bad HomburgGermany
- Telephone:
- +49 6172 686 0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.fresenius.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Centre Manager, Oxford Brookes Centre for Nutrition and Health (OxBCNH), Department of Sport, Health Sciences and Social Work, Faculty of Health & Life Sciences, Oxford Brookes UniversityMChem, MSc, ANutr Isabel ButlerGipsy Lane Campus, HeadingtonOX3 0BP OxfordUnited Kingdom
- Telephone:
- +44 (0) 1865-483297
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Centre Manager, Oxford Brookes Centre for Nutrition and Health (OxBCNH), Department of Sport, Health Sciences and Social Work, Faculty of Health & Life Sciences, Oxford Brookes UniversityMChem, MSc, ANutr Isabel ButlerGipsy Lane Campus, HeadingtonOX3 0BP OxfordUnited Kingdom
- Telephone:
- +44 (0) 1865-483297
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Centre Manager, Oxford Brookes Centre for Nutrition and Health (OxBCNH), Department of Sport, Health Sciences and Social Work, Faculty of Health & Life Sciences, Oxford Brookes UniversityMChem, MSc, ANutr Isabel ButlerGipsy Lane Campus, HeadingtonOX3 0BP OxfordUnited Kingdom
- Telephone:
- +44 (0) 1865-483297
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Fresenius Kabi Deutschland GmbHElse-Kröner-Straße 161352 Bad HomburgGermany
- Telephone:
- +49 6172 686 0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.fresenius.de
Ethics Committee
Address Ethics Committee
- Address:
- University Research Ethics Committee (UREC) at Oxford Brookes UniversityHeadington CampusOX3 0BP OxfordUnited Kingdom
- Telephone:
- +44 (0) 1865 48 56
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-07-19
- Ethics committee number:
- 140806
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-08-09
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry