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Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose or Sucrose in Infants

NCT ID: NCT02247102

Last Updated: 2014-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

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The study shall investigate whether isomaltulose

* is digested and absorbed to a comparable degree like other carbohydrates (CHO) used as ingredients for this age group (e.g. sucrose), by measuring the H2 exhalation in the postprandial period
* does not mediate abdominal discomfort or diarrhoea and is therefore as well tolerated as other CHO (e.g. sucrose), by/in healthy infants aged 6 to 12 months.

It is hypothesized that isomaltulose, provided with a standard follow-on formula,

1. will not significantly increase the mean basal breath H2-excretion rate (determined as the incremental area under the curve (iAUC) of H2-exhalation) over a 3 h postprandial period compared to a sucrose containing standard follow-on formula.
2. will not lead to a significantly different gastrointestinal tolerance in the conse-quent 24 h after formula consumption compared to a sucrose containing standard follow-on formula in infants aged 6 to 12 months.

Detailed Description

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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.

Conditions

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Malabsorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Isomaltulose

Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)

Group Type EXPERIMENTAL

Isomaltulose

Intervention Type 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).

Sucrose

Intervention Type 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).

Sucrose

Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)

Group Type ACTIVE_COMPARATOR

Isomaltulose

Intervention Type 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).

Sucrose

Intervention Type 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).

Interventions

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Isomaltulose

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).

Intervention Type DIETARY_SUPPLEMENT

Sucrose

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).

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Palatinose™

Eligibility Criteria

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Inclusion Criteria

1. Subject was healthy-born at term (37th-42th gestational week) and is healthy at the time of pre-examination
2. Subject is aged 6-12 months at the time of pre-examination
3. Subject ranges between 5th and 95th percentile for age (EURO Growth Guide-lines)
4. Subject has been formula-fed (and complementary food, such as fruit or car-rots, have already been introduced) and not exclusively breast-fed for at least 4 weeks prior onset of the trial
5. Parents/caretakers understand the English or Hebrew language and are able and willing to follow the study instructions and fill out questionnaires
6. Subject is suitable for participation in the study according to the PI/study per-sonnel
7. Parents/caretakers have voluntarily agreed to participate and successfully completed the informed consent form (ICF)

Exclusion Criteria

1. Subject is a pre-term (\<37th gestational week)
2. Subject or mother is suffering from an acute or chronic disease followed by medication therapy at the time of pre-examination
3. Subject is suffering from (congenital) gastrointestinal disease or malformation (followed by medication)
4. Subject is suffering/ suffered from infection (which lead to diarrhoea or vomit-ing) in previous 14 days
5. Subject has been administered antibiotics and/or laxatives in the previous 14 days prior to the start of the intervention
6. Subject has a (hereditary) fructose/lactose intolerance and/or (food) allergy
7. Subject is suffering from carbohydrate malabsorption
8. Drug or alcohol abuse by mother of subject
9. Subject is a hydrogen non producer.
10. Subject is currently involved or will be involved in another clinical or food study
11. Subject is not suitable for participation in the study according to the PI/study personnel
12. It is impossible for the subject to travel to the study center on Study Days 1 and 2
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beneo GmbH

INDUSTRY

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nachum Vaisman, MD

Role: PRINCIPAL_INVESTIGATOR

The Tel Aviv Sourasky Medical Center

Locations

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The Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Nachum Vaisman, MD

Role: CONTACT

Phone: +972.524.266.596

Email: [email protected]

Carolin Sieland

Role: CONTACT

Phone: +49 6359 803 831

Email: [email protected]

Other Identifiers

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TASMC-14-NV-132-CTIL

Identifier Type: -

Identifier Source: org_study_id