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ID
Source
Brief title
Health condition
Diabetes Mellitus type 2
Sponsors and support
Intervention
Outcome measures
Primary outcome
4-hour postprandial blood glucose response after consumption of diabetes-specific or standard ONS (iAUC0-4h).
Secondary outcome
1. 4-hour postprandial responses after consumption of diabetes-specific or standard ONS:
A. Blood glucose levels (iAUC0-4h) (serving size);
B. Blood insulin levels (iAUC0-4h);
C. Blood glucagon levels (iAUC0-4h).
2. Postprandial peak blood glucose, insulin and glucagon levels;
3. Postprandial delta peak blood glucose, insulin and glucagon levels.
Background summary
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.
Study objective
Diabetes specific oral nutritional supplement has an improved 4-hour postprandial glucose response compared to standard oral nutritional supplement.
Study design
Screening, Baseline, Day 1, Day 2, Day 3, Follow up.
Intervention
Duration of intervention: 3 days.
Intervention group: A high-energy, high-protein diabetes-specific ONS.
Control group: An isocaloric high-energy, high-protein ONS.
P.O.Box 7005
Marjolein Vossers
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467955
marjolein.vossers@danone.com
P.O.Box 7005
Marjolein Vossers
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467955
marjolein.vossers@danone.com
Inclusion criteria
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.
Exclusion criteria
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.
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 |
---|---|
NTR-new | NL3576 |
NTR-old | NTR3734 |
Other | Danone Research : Dia.6.C/A |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |