Not applicable
ID
Bron
Verkorte titel
Aandoening
Not applicable
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is the glycemic index of the test products
Achtergrond van het onderzoek
This is a generic protocol for the assessment of glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or (one of) the test product(s). Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Appetite and liking will be assessed by completing a VAS scale on several time-points. Several nutritional products will be tested over time.
Doel van het onderzoek
Not applicable
Onderzoeksopzet
Time points of the outcome; for example: V0 (screening); V1; V2 (≥48 hrs), V# (≥48 hrs)
Onderzoeksproduct en/of interventie
Duration of intervention: depending on number of test products
Intervention group:
- Test product(s):
All test products contain 25 or 50 g of available carbohydrates.
- Reference product (one to be chosen):
a) anhydrous glucose powder (25 or 50 g)
b) dextrose (glucose monohydrate, 27,5 or 55 g)
c) commercial solution containing glucose (25 or 50 g)
Publiek
Danone Nutricia Research
+31 30 2095 000
register.clinicalresearchnutricia@danone.com
Wetenschappelijk
Danone Nutricia Research
+31 30 2095 000
register.clinicalresearchnutricia@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Known Diabetes Mellitus type I or type II, rebound hypoglycaemia and/or any other medical condition that interferes with glucose
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 relevant food allergy or intolerance
5. Adherence to a strict vegan diet and/or a weight loss program
6. Any known bleeding disorder
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8151 |
| CCMO | NL71190.056.19 |
| OMON | NL-OMON49247 |