Measurement of the glycaemic index (GI) of Diben 2 KCAL Drink and Renalive HIGH PROTEIN in healthy subjects
Organizational Data
- DRKS-ID:
- DRKS00032832
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2023-10-23
- Last update in DRKS:
- 2023-10-23
- Registration type:
- Prospective
Acronym/abbreviation of the study
GCOS-011-CEN
URL of the study
No Entry
Brief summary in lay language
In this study the effect of two enteral nutrition formulations on blood glucose levels is measured (determination of theglycaemic index)
Brief summary in scientific language
The glycemic index of two enteral nutrition formulations will be determined in this study. The study will be performed according to ISO 26642. The test products will be compared with glucose dissolved in water as reference. The orally administered volume of products contains a comparable amount of available carbohydrates. Each subject will test each 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 2 KCAL Drink, once p.o., volume containing 25 g or 50 g available carbohydrates (depending on results of nutrient analysis)
- Arm 2:
- Renalive HIGH PROTEIN, once p.o., volume containing 25 g or 50 g available carbohydrates (depending on results of nutrient analysis)
- Arm 3:
- Glucose (glucose monohydrate) dissolved in water as reference, 25 g or 50 g p.o. on 3 separate days. Participants act as their own control.
Endpoints
- Primary outcome:
- Glycaemic index (GI). Blood samples will be taken at -5 min and 0 min before consumption of the product. The baseline value taken as a mean of these two values. The product will be consumed immediately after this within 15 minutes and further bloodsamples will be taken at 15, 30, 45, 60, 90 and 120 minutes after starting to eat/drink.
- Secondary outcome:
- none
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 planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- United Kingdom
- Number of study centers:
- Monocenter study
- Recruitment location(s):
- No Entry
Recruitment period and number of participants
- Planned study start date:
- 2023-10-28
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 10
- Final Sample Size:
- No Entry
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 ISO26642 and study protocol
Exclusion Criteria
- Aged < 18 or > 60 years; - Pregnant or lactating; - Body mass index (BMI) < 18.5 kg/m2 or > 30 kg/m2; - Known history of diabetes mellitus or fasting blood glucose value > 6.1 mmol/l or the use of anti-hyperglycaemic drugsor 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 influencedigestion 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 glucosemetabolism and body fat distribution); - Suspicion of alcohol abuse (defined as an average daily intake of more than 6 units of alcohol per day, e.g. more than 2 pints of beer per day or equivalent amount of alcohol in other beverages) or drug abuse; - Participants who are unable to comply with experimental procedures or do not follow GI testing safety guidelines or are not able to tolerate fasting condition for at least 10 hours
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://fresenius.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Oxford Brookes Centre for Nutrition and Health (OxBCNH), Department of Sport, Health Sciences and Social Work, Faculty of Health & Life Sciences, Oxford Brookes UniversityDr Sangeetha ThondreHeadington Campus, Gipsy LaneOX3 0BP OxfordUnited Kingdom
- Telephone:
- +44 (0) 1865 483988
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://cnh.brookes.ac.uk/
Contact for Public Queries
- Address:
- Oxford Brookes Centre for Nutrition and Health (OxBCNH), Department of Sport, Health Sciences and Social Work, Faculty of Health & Life Sciences, Oxford Brookes UniversityDr Sangeetha ThondreHeadington Campus, Gipsy LaneOX3 0BP OxfordUnited Kingdom
- Telephone:
- +44 (0) 1865 483988
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://cnh.brookes.ac.uk/
Principal Investigator
- Address:
- Oxford Brookes Centre for Nutrition and Health (OxBCNH), Department of Sport, Health Sciences and Social Work, Faculty of Health & Life Sciences, Oxford Brookes UniversityDr Sangeetha ThondreHeadington Campus, Gipsy LaneOX3 0BP OxfordUnited Kingdom
- Telephone:
- +44 (0) 1865 483988
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://cnh.brookes.ac.uk/
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Fresenius Kabi Deutschland GmbHElse-Kröner-Straße 1 61352 Bad Homburg61352 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 RoadOX3 0BP OxfordUnited Kingdom
- Telephone:
- +44 1865 484204
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.brookes.ac.uk/sites/research-support/research-ethics-and-integrity/university-research-ethics-committee-urec
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-02-26
- Ethics committee number:
- 140806
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-02-28
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