Diabetes specific oral nutritional supplement has an improved 4-hour postprandial glucose response compared to standard oral nutritional supplement.
ID
Bron
Verkorte titel
Aandoening
Diabetes Mellitus type 2
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
4-hour postprandial blood glucose response after consumption of diabetes-specific or standard ONS (iAUC0-4h).
Achtergrond van het onderzoek
In this study the effect of a diabetes-specific oral nutritional supplement (ONS) on the 4-hour postprandial glucose response will be compared to a standard ONS in adults with type 2 diabetes with (risk of) malnutrition.
Doel van het onderzoek
Diabetes specific oral nutritional supplement has an improved 4-hour postprandial glucose response compared to standard oral nutritional supplement.
Onderzoeksopzet
Screening, Baseline, Day 1, Day 2, Day 3, Follow up.
Onderzoeksproduct en/of interventie
Duration of intervention: 3 days.
Intervention group: A high-energy, high-protein diabetes-specific ONS.
Control group: An isocaloric high-energy, high-protein ONS.
Publiek
P.O.Box 7005
Marjolein Vossers
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467955
marjolein.vossers@danone.com
Wetenschappelijk
P.O.Box 7005
Marjolein Vossers
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467955
marjolein.vossers@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age ≥ 18 yrs;
2. (At risk of) malnourishment, based on the presence of one or more of the following criteria:
A. ≥ 5% involuntary weight loss in the last month, or;
B. ≥ 10% involuntary weight loss in the last 6 months, or;
C. Serum albumin < 35 g/L, or;
D. Age ≥ 70 yrs and body mass index (BMI) < 21.0 kg/m2, or;
D. Age < 70 yrs and BMI < 18.5 kg/m2, or;
E. Age ≥ 65 yrs and Short Mini Nutritional Assessment (MNA) score ≤ 11.
3. Diagnosis of type 2 diabetes for at least six months;
4. On stable (20%) anti-hyperglycaemic therapy (oral medication and/or insulin) for at least 1 month prior to study entry;
5. Willingness and ability to comply with the study protocol, including: An overnight fast (at least 10 hours) at each study day.
6. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis);
2. Any known severe disease, i.e.:
A. Heart failure (New York Heart Association (NYHA) class IV);
B. Kidney disease (Chronic Kidney Disease (CKD) ≥ stage 4);
C. Hepatic disease (transaminases > 5 times upper limit of normal);
D. Severe anemia (hemoglobin <8 g/dl or 5 mmol/L).
3. (Metabolic) disorders interfering with stable glucose metabolism (i.e. uncontrolled thyroid and/or adrenal disease, or interfering malignant diseases);
4. Concurrent condition /treatment that interferes with stable glucose metabolism (i.e. immediately post-operative);
5. Major infections (requiring antibiotics) within 3 weeks prior to study entry;
6. Concomitant therapy with systemic glucocorticoids within 2 weeks prior to study entry;
7. Pregnant female;
8. Requirement of a fibre-free diet;
9. Intolerance or allergy to dairy or other ingredients of the study products;
10. Alcohol intake of > 21 units per week for men and > 14 units per week for women;
11. Swallowing disorders making consumption of an oral nutritional supplement impossible;
12. Parenteral feeding / tube feeding;
13. Investigators' uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
14. Participation in any other studies involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL3576 |
NTR-old | NTR3734 |
Ander register | Danone Research : Dia.6.C/A |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |