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| Name | Class |
|---|---|
| Beneo GmbH | INDUSTRY |
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The study shall investigate whether isomaltulose
It is hypothesized that isomaltulose, provided with a standard follow-on formula,
The intervention will be scheduled on Study Day 1 and Study Day 2. The caretakers will be asked to feed their infant with their usual standard formula in the morning of Study Day 1 and Study Day 2 at home (at their regular feeding time). At the study center, the infant will consume his usual follow-up formula in the usual amount to wich the study product (palatinose or sucrose 1 gram/kg body weight) will be added to the nearest 0.5 kg weight. The introduction will be in the second meal of the day and the time between the first feeding and the interventionwill be of 4h. Before and after the single consumption of the study formula (baseline vs. test condition), the H2 exhalation of the infant will be measured and monitored every 30 min for an additional period of 3 h. In between Study Days 1 and 2, a wash-out period of at least 2 days will be implemented to reduce the potential occurrence of carry-over effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isomaltulose | Experimental | Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg) |
|
| Sucrose | Active Comparator | Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isomaltulose | Dietary Supplement | Each subject receives isomaltulose on Study Day 1. After having completed the wash-out period, each subject receives sucrose on Study Day 2. Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg). |
| Measure | Description | Time Frame |
|---|---|---|
| hydrogen breath | 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nachum Vaisman, MD | Contact | +972.524.266.596 | nachumv@tlvmc.gov.il | |
| Carolin Sieland | Contact | +49 6359 803 831 | Carolin.Sieland@beneo.com |
| Name | Affiliation | Role |
|---|---|---|
| Nachum Vaisman, MD | The Tel Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C008189 | isomaltulose |
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Sucrose | Dietary Supplement | Each subject receives sucrose on Study Day 1. After having completed the wash-out period, each subject receives isomaltulose on Study Day 2. Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg). |
|
| D009750 | Nutritional and Metabolic Diseases |
| D000073893 |
| Sugars |