Measurement of the glycaemic index (GI) of enteral nutrition formulations in healthy subjects
Organizational Data
- DRKS-ID:
- DRKS00025495
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-06-17
- Last update in DRKS:
- 2022-07-08
- Registration type:
- Prospective
Acronym/abbreviation of the study
GCOS-008-CEN
URL of the study
No Entry
Brief summary in lay language
In this study the effect of seven products for enteral nutrition on blood glucose levels is measured (determination of the glycemic index, GI).
Brief summary in scientific language
The glycemic index of seven products for enteral nutrition (sip and tube feeds) is determined in this study. The study is performed according to ISO 26642: Food products - Determination of the glycaemic index (GI) and recommendation for food classification (First edition 2010-10-01). The test products are compared with glucose dissolved in water as reference. The orally administered volume of each product contains a comparable amount of available carbohydrates (25g or 50g depending on results of nutrient analyses). Each subject tests each test product once and the reference product three times on separate days, with at least a one-day gap between measurements. Subjects are 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 volunteers
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Supportan DRINK (Tropical fruits), once p.o., volume containing 25 g oder 50 g available carbohydrates (depending on results of nutrient analysis)
- Arm 2:
- Survimed OPD DRINK (Vanilla), once p.o., volume containing 25 g oder 50 g available carbohydrates (depending on results of nutrient analysis)
- Arm 3:
- Fresubin 3.2 kcal DRINK (Vanilla-Caramel), once p.o., volume containing 25 g oder 50 g available carbohydrates (depending on results of nutrient analysis)
- Arm 4:
- Fresubin Energy DRINK (Vanilla), once p.o., volume containing 25 g oder 50 g available carbohydrates (depending on results of nutrient analysis)
- Arm 5:
- Fresubin Protein Energy DRINK (Vanilla), once p.o., volume containing 25 g oder 50 g available carbohydrates (depending on results of nutrient analysis)
- Arm 6:
- Fresubin Diabetes (Neutral), once p.o., volume containing 25 g oder 50 g available carbohydrates (depending on results of nutrient analysis)
- Arm 7:
- Diben DRINK (Cappuccino), once p.o., volume containing 25 g oder 50 g available carbohydrates (depending on results of nutrient analysis)
- Arm 8:
- Glucose, 25 g or 50 g p.o. on 3 separate days
Endpoints
- Primary outcome:
- Glycemic index (GI)
- Secondary outcome:
- n.a
Study Design
- Purpose:
- Basic research/physiological study
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- 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:
- 2021-07-15
- Actual study start date:
- 2021-08-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2022-04-15
- 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
1. Aged < 18 or > 60 years; 2. Pregnant or lactating; 3. Body mass index (BMI) > 30kg/m2; 4. Known history of diabetes mellitus or fasting blood glucose value > 6.1 mmol/l or the use of anti-hyperglycaemic drugs or insulin; 5. Any known food allergy or intolerance; 6. 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); 7. Hospitalization within the preceding 3 months; 8. Use of steroids, protease inhibitors, amphetamines or antipsychotics; 9. 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:
- No Entry
- 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 University,MChem, 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 University,MChem, 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 University,MChem, 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:
- No Entry
- 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 University, Headington Campus [University Research Ethics Committee (UREC) at Oxford Brookes University ]OX3 0BP OxfordUnited Kingdom
- Telephone:
- No Entry
- 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:
- 2021-02-16
- Ethics committee number:
- UREC-Registrierungsnummer: 140806
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-02-19
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