The objective of this study is to measure the postprandial glycemic response to several nutritional products.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
GI = Capillary blood glucose iAUC0-120 [mmol/l] of test product/ mean capillary
blood glucose iAUC0-120 [mmol/l] of reference product
Secondary outcome
- GL=GI*available carbohydrate/given amount
- Capillary blood glucose mmol/l and iAUC0-120 [mmol/l*min] of the reference
product and test product(s)
- Capillary blood glucose iCmax [mmol/l] and Tmax [min] of the reference
product and test product(s)
- Appetite profile and liking of the test product using visual analogue scales
Background summary
Elevated blood glucose levels (hyperglycemia) are known to cause metabolic
changes that affect health and disease parameters. Several studies indicate
that improvement in glycemic control results in lower rates of hospital
complications.
The GI is an intrinsic property of a food that reflects the postprandial
glycemic impact compared with an equivalent carbohydrate portion of glucose in
solution. Low GI foods are those containing carbohydrates causing less
fluctuation in blood glucose and insulin levels than high GI foods.
To our knowledge, the GI of the study products have not been measured. The aim
of this study is therefore to measure the postprandial glycemic response to
these products.
Study objective
The objective of this study is to measure the postprandial glycemic response to
several nutritional products.
Study design
This is a randomised controlled, open label, single-centre study.
Intervention
- Several nutritional products containing 25 or 50 grams of carbohydrates
(testproduct)
- Standard glucose solution (reference product) (250 ml, contains 25 or 50
grams of glucose)
Study burden and risks
Subjects should take during the study visits (with a minimum of 48 hours
between the separate visits) a nutritional product containing 25 or 50 grams
carbohydrates or a standard glucose solution (250 ml, contains 25 or 50 grams
of glucose). During a study visit, blood is sampled using a finger prick just
before and after the intake at 8 timepoints spread over 2,5 hours for analysis
of glucose and a questionnaire is completed at 4 timepoints. A few days after
the last study visit a follow-up phone call will be done.
During participation subjects should adhere to a number of rules related to
medication use and lifestyle.
The study will be performed with healthy adult volunteers and the subjects will
take a nutritional product or a standard glucose solution once every visit. The
intake of the nutritional products is not expected to cause adverse events. The
intake of the standard glucose solution may cause nausea, stomach complaints
and/or thirst. The risks of the other study procedure are very limited as well
and will be performed / guided by qualified study staff.
The burden for participants in this study is considered small and the benefits
of obtaining more knowledge on the characteristics of nutritional products
outweighs the minimal burden.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
1. Age * 18 and * 60 years
2. Body Mass Index (BMI) * 18.5 and * 24.9 kg/m2
3. Written informed consent
4. Willingness and ability to comply with the protocol
5. Judged by the investigator to be in good health
Exclusion criteria
1. Known Diabetes Mellitus type I or type II, rebound hypoglycemia and/or any
other medical condition that interferes with glucose metabolism
2. Any use of anticoagulants, steroids, protease inhibitors or antipsychotics
and/or any medication known to affect glucose tolerance and/or to influence
digestion and absorption of nutrients within 1 week of screening, in opinion of
the investigator
3. Any known disease which influence digestion and absorption of nutrients
within 1 week of screening
4. Any known food allergy or intolerance
5. Adherence to a strict vegan diet and/or a weight loss program
6. Any known bleeding disorder
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71190.056.19 |
| Other | NTR: NL8151 |