Health BehaviorNCT01116115
The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters in Infants (InFat_005)
A study testing InFat™ based infant formula and Standard vegetable oil based infant formula in people with Health Behavior and Disorder of Growth and Development, run by Enzymotec at 1 site in Israel.
Trial summary
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters in term formula fed infants. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Disorder of Growth and Development
- What is being tested?
- InFat™ based infant formula and Standard vegetable oil based infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parental/ legal guardian written inform consent
- The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group).
- Term infants of born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
- Birth weight appropriate for gestational age (AGA).
- The infant is apparently healthy at birth and entry to study.
- Apgar after 5 minutes >7
Show all 9Show fewer
- Enrolled within their first 7 days of life
- The infant is a product of normal pregnancy and delivery, including C-section.
- Parental ability to attend visits and interviews and willing to fill questionnaires.
Who cannot join
- Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant or according to PI discretion may interfere with study results.
- The infant suffers from a major congenital abnormality, a disease or chromosomal disorder with a clinical significance that can be detected at or around birth.
- The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
- The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
- The infant or mother was treated with antibiotics around birth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters, Anthropometric Parameters and Stool Characteristics in Term Infants
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters in term formula fed infants.
Read the detailed description
InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty acids) and easy digestion. These benefits are the result of a unique fatty acid composition on the glycerol backbone, which ensures high level of palmitic acid at the middle (sn-2) position.
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters, anthropometric parameters and stool characteristics in formula fed term infants.
- Being tested
- InFat™ based infant formula, Standard vegetable oil based infant formula
- Keywords
- Term Infants, Intestine flora, Stool characteristics
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InFat™ based infant formulaOther
Also called High sn-2 palmitic acid, structured triglyceride
High sn-2 palmitic acid oil based infant formula
Standard vegetable oil based infant formulaOther
Also called Standard vegetable oil
Standard vegetable oil based infant formula
| Study group | Role | What they receive |
|---|---|---|
| Standard vegetable oil based formula | Active comparator | Not described Receives: Other: Standard vegetable oil based infant formula |
| InFat™ based infant formula | Active comparator | Not described Receives: Other: InFat™ based infant formula |
| Breast-fed | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal flora composition
infant feces microbial analysis
Measured: Baseline, 5 weeks
Secondary outcomes (2)
Anthropometric measurements
Body length, weight, and head circumferences
Measured: Baseline, 5 weeks
General Health and Well being
Physical examinations, Health (dieases, doctor visits) and well being (sleeping, crying) questionnaires, medications report
Measured: Baseline, 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Arie Riskin, MD, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116115
- Sponsor's protocol ID
- InFat_005
- Status last verified
- May 2011
- First submitted
- 7 Apr 2010
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yaron S, Shachar D, Abramas L, Riskin A, Bader D, Litmanovitz I, Bar-Yoseph F, Cohen T, Levi L, Lifshitz Y, Shamir R, Shaoul R. Effect of high beta-palmitate content in infant formula on the intestinal microbiota of term infants. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):376-81. doi: 10.1097/MPG.0b013e31827e1ee2.
PubMed 23201699
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters, Anthropometric Parameters and Stool Characteristics in Term Infants
- ClinicalTrials.gov ID
- NCT01116115
- Acronym / sponsor ID
- InFat_005
- Keywords
- Term Infants, Intestine flora, Stool characteristics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EnzymotecIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters in term formula fed infants.
Detailed description
InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty acids) and easy digestion. These benefits are the result of a unique fatty acid composition on the glycerol backbone, which ensures high level of palmitic acid at the middle (sn-2) position.
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters, anthropometric parameters and stool characteristics in formula fed term infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard vegetable oil based formula | Active comparator | Other: Standard vegetable oil based infant formula |
| InFat™ based infant formula | Active comparator | Other: InFat™ based infant formula |
| Breast-fed | No intervention | – |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Parental/ legal guardian written inform consent
- The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group).
- Term infants of born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
- Birth weight appropriate for gestational age (AGA).
- The infant is apparently healthy at birth and entry to study.
Key exclusion criteria (5 listed)
- Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant or according to PI discretion may interfere with study results.
- The infant suffers from a major congenital abnormality, a disease or chromosomal disorder with a clinical significance that can be detected at or around birth.
- The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
- The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
- The infant or mother was treated with antibiotics around birth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InFat™ based infant formulaAlso: High sn-2 palmitic acid, structured triglycerideHigh sn-2 palmitic acid oil based infant formula | Other | InFat™ based infant formula |
| Standard vegetable oil based infant formulaAlso: Standard vegetable oilStandard vegetable oil based infant formula | Other | Standard vegetable oil based formula |
Primary outcome
Intestinal flora composition
Time frame: Baseline, 5 weeks
infant feces microbial analysis
2 secondary outcomes
Anthropometric measurements
Time frame: Baseline, 5 weeks
General Health and Well being
Time frame: Baseline, 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- Derived from this study: PubMed 23201699Yaron S, Shachar D, Abramas L, Riskin A, Bader D, Litmanovitz I, Bar-Yoseph F, Cohen T, Levi L, Lifshitz Y, Shamir R, Shaoul R. Effect of high beta-palmitate content in infant formula on the intestinal microbiota of term infants. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):376-81. doi: 10.1097/MPG.0b013e31827e1ee2.
Related trials for Health Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arie Riskin, MD principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InFat™ based infant formula and Standard vegetable oil based infant formula in people with Health Behavior and Disorder of Growth and Development, run by Enzymotec at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal flora composition (time frame: Baseline, 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01116115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.