Personal SatisfactionInFat_002NCT00874068
The Effects of Dietary Palmitic Acid Triacylglyceride Position on Bone Strength Parameters in Infants
A study testing InFat™ based infant formula and Standard vegetable oil based infant formula in people with Personal Satisfaction, 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 bone strength parameters. Read more about this study
- Who is it for?
- Ages Up to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Personal Satisfaction
- 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
- 94 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to 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 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age above 32 weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
- Birth weight appropriate for gestational age (AGA) using current CDC growth charts, and above 1750gr.
- 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).
- The infant is apparently healthy.
- Parental/ legal guardian written inform consent
- Apgar after 5 minutes >7
- Enrolled within their first 14 days of life for term infants and first month of life for preterm infants
- At enrollment: clinical stability and acceptable weight gain
Who cannot join
- The infant suffer from a congenital or chromosomal disorder (Cystic fibrosis, Tracheomalacia, Tracheoesophageal fistula, major congenital heart disease, down-syndrome)
- The infant suffer from neonatal morbidities:
- Bronchopulmonary dysplasia (BPD)
- Intraventricular Hemorrhage3-4 (IVH)
- Necrotizing Enterocolitis (NEC)
- Laboratory or clinical sings of Osteopenia
Show all 9Show fewer
- The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
- The mother suffers from any disease or disability that may interfere with her ability to take care of her infant
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Dietary Palmitic Acid Triacylglyceride Position on Anthropometric Measures, Bone Strength Parameters, Stool Characteristics and Stool Biochemistry in Preterm and Term Infants
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters.
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 results of a unique fatty acid composition on the glycerol backbone, which ensure 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 bone strength parameters, anthropometric parameters, wellbeing and stool characteristics in term and preterm infants.
- Conditions
- Personal Satisfaction
- Being tested
- InFat™ based infant formula, Standard vegetable oil based infant formula
- Keywords
- term infants, preterm infants, bone strength, Speed of sound (SOS), Ultrasound
- Medical subject headings
- Personal Satisfaction
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 formula | Active comparator | Not described Receives: Other: Standard vegetable oil based infant formula |
| InFat | 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.
bone strength parameters
Measured: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
Secondary outcomes (2)
stool characteristics
Measured: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
Antropometric measurements
Measured: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startFeb 2009
- 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 Personal SatisfactionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dan Nemet, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874068
- Sponsor's protocol ID
- PAL1
- Acronym
- InFat_002
- Status last verified
- Feb 2011
- First submitted
- 31 Mar 2009
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Litmanovitz I, Bar-Yoseph F, Lifshitz Y, Davidson K, Eliakim A, Regev RH, Nemet D. Reduced crying in term infants fed high beta-palmitate formula: a double-blind randomized clinical trial. BMC Pediatr. 2014 Jun 19;14:152. doi: 10.1186/1471-2431-14-152.
PubMed 24942975
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 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 Anthropometric Measures, Bone Strength Parameters, Stool Characteristics and Stool Biochemistry in Preterm and Term Infants
- ClinicalTrials.gov ID
- NCT00874068
- Acronym / sponsor ID
- InFat_002 / PAL1
- Conditions
- Personal Satisfaction
- Keywords
- term infants, preterm infants, bone strength, Speed of sound (SOS), Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- EnzymotecIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Apr 2009 (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 bone strength parameters.
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 results of a unique fatty acid composition on the glycerol backbone, which ensure 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 bone strength parameters, anthropometric parameters, wellbeing and stool characteristics in term and preterm infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard vegetable oil formula | Active comparator | Other: Standard vegetable oil based infant formula |
| InFat | Active comparator | Other: InFat™ based infant formula |
| Breast-fed | No intervention | – |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Gestational age above 32 weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
- Birth weight appropriate for gestational age (AGA) using current CDC growth charts, and above 1750gr.
- 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).
- The infant is apparently healthy.
- Parental/ legal guardian written inform consent
Key exclusion criteria (9 listed)
- The infant suffer from a congenital or chromosomal disorder (Cystic fibrosis, Tracheomalacia, Tracheoesophageal fistula, major congenital heart disease, down-syndrome)
- The infant suffer from neonatal morbidities:
- Laboratory or clinical sings of Osteopenia
- The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
- The mother suffers from any disease or disability that may interfere with her ability to take care of her infant
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 |
| Standard vegetable oil based infant formulaAlso: standard vegetable oilstandard vegetable oil based infant formula | Other | Standard vegetable oil formula |
Primary outcome
bone strength parameters
Time frame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
2 secondary outcomes
stool characteristics
Time frame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
Antropometric measurements
Time frame: baseline, 40 corrected gestation weeks, 6 weeks, 12 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 24 Feb 2011.
- Derived from this study: PubMed 24942975Litmanovitz I, Bar-Yoseph F, Lifshitz Y, Davidson K, Eliakim A, Regev RH, Nemet D. Reduced crying in term infants fed high beta-palmitate formula: a double-blind randomized clinical trial. BMC Pediatr. 2014 Jun 19;14:152. doi: 10.1186/1471-2431-14-152.
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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.
Dan Nemet, MD principal investigator
Meir 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 Personal Satisfaction, 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 8 inclusion and 9 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 24 Feb 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?
bone strength parameters (time frame: baseline, 40 corrected gestation weeks, 6 weeks, 12 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 NCT00874068, 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 24 Feb 2011.