Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 93 of 748 for:    Area Under Curve AND meal

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247102
Recruitment Status : Unknown
Verified December 2014 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : September 23, 2014
Last Update Posted : December 25, 2014
Sponsor:
Collaborator:
Beneo GmbH
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Malabsorption Dietary Supplement: Isomaltulose Dietary Supplement: Sucrose Phase 3

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Placebo-controlled Randomized Trial to Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose (Palatinose™) or Sucrose in Infants Aged 6-12 Months
Study Start Date : September 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arm Intervention/treatment
Experimental: Isomaltulose
Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)
Dietary Supplement: 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).

Other Name: Palatinose™

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).


Active Comparator: Sucrose
Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)
Dietary Supplement: 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).

Other Name: Palatinose™

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).





Primary Outcome Measures :
  1. hydrogen breath [ Time Frame: 3 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247102


Contacts
Layout table for location contacts
Contact: Nachum Vaisman, MD +972.524.266.596 nachumv@tlvmc.gov.il
Contact: Carolin Sieland +49 6359 803 831 Carolin.Sieland@beneo.com

Locations
Layout table for location information
Israel
The Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Beneo GmbH
Investigators
Layout table for investigator information
Principal Investigator: Nachum Vaisman, MD The Tel Aviv Sourasky Medical Center

Layout table for additonal information
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02247102     History of Changes
Other Study ID Numbers: TASMC-14-NV-132-CTIL
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases