The aim of the present study is to assess whether the postprandial glucose response of the new test products is superior to the postprandial glucose response of an original treatment option.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter in this study is the rate of decline in glucose
(mmol/hour) after reaching peak glucose levels (Cmax) until reaching baseline
(t = -5) blood glucose levels or, in case baseline blood glucose levels are not
reached, the lowest observed blood glucose level.
Secondary outcome
• incremental Area Under the Curve (iAUC) for:
o glucose (mmol/L/hrs)
o insulin (pmol/L/hrs)
o paracetamol (mg/L/hrs)
• incremental peak levels (iCmax) of:
o glucose (mmol/L)
o insulin (pmol/L)
o paracetamol (mg/L)
• time to peak levels (Tmax) of:
o glucose (min)
o insulin (min)
o paracetamol (min)
Background summary
Nutricia has a range of formulas on the market including medical formulas
addressing specific needs of patients who are at risk for hypoglycaemia. A new
product is currently under development.
Study objective
The aim of the present study is to assess whether the postprandial glucose
response of the new test products is superior to the postprandial glucose
response of an original treatment option.
Study design
The study has a double-blind, crossover design with healthy volunteers taking
one serving of the products in a randomized order.
Intervention
Participants will receive a single bolus of study product (50g carbohydrate
equivalent) together with paracetamol (1 gram) at the start of each test day.
Study burden and risks
Subjects should visit the study site 4 times: one screening visit and three
study visits. During each study visit, the subjects will get a bolus with one
of the study products and paracetamol, and blood is sampled using a cannula in
the arm at 13 time points in 6 hours for analysis of blood glucose, insulin and
paracetamol.
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 3 study products are at random assigned to the subjects on
each visit. Participation in the study is expected to cause minimal discomfort
for the subject. The risks of the other study procedures are very limited as
well; there is a small risk of experiencing pain/discomfort from the cannula.
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. Healthy individuals, 18 up to and including 50 years of age.
2. Willing to maintain habitual diet, physical activity pattern, and body
weight throughout the trial.
3. Willing to avoid the consumption of alcohol, unusual food intake, unusual
physical activity 24h prior to each study visit.
4. Willing to come to the study visit in the morning after an overnight fast of
minimum 10 hours and maximum 14 hours (with water only).
Exclusion criteria
1. Abnormal blood glucose levels at screening (not fasted) in the opinion of
the investigator.
2. Known history of gastrointestinal disease (e.g., diverticulitis, Crohn*s
disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history
or presence of clinically important endocrine (including Type 1 or Type 2
diabetes mellitus), or any condition which might, in the opinion of the
Principal Investigator either: 1) make participation dangerous to the subject
(e.g. anaemia) or to others, or 2) affect the results.
3. Use of medications known to influence carbohydrate metabolism,
gastrointestinal function or appetite, including, but not limited to adrenergic
blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids
within 4 weeks of the screening visit, or any medication which might, in the
opinion of the Principal Investigator either: 1) make participation dangerous
to the subject or to others, or 2) affect the results.
4. Use of medications known to influence gastric emptying (including but not
limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking
drugs, antacids and metoclopramide).
5. Use of anti-clotting medications.
6. Current tobacco smokers or smokers that quite smoking < 1 month prior to
screening (except for occasional (<= 3) cigarettes/cigars/pipes per week on
average over the past month).
7. Self-reported pregnancy or breastfeeding.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82867.056.22 |