Health BehaviorNCT01373541
Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China
A study testing InFat™ based infant formula and Standard vegetable oil based infant formula in people with Health Behavior and Personal Satisfaction, run by Enzymotec at 1 site in China.
Trial summary
The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, 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
- 171 participants
- Where
- 1 siteChina
- Study dates
- May 2011to May 2013
- 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 1 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parental/legal guardian written informed consent;
- The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants).
- Term infant of Chinese origin born at 37-42 gestation weeks
- Birth weight appropriate for gestational age (AGA), 2500-4000grams
- The infant is apparently healthy at birth and entry of study.
Who cannot join
- Adverse maternal, fetal or infant medical history that can potentially affect efficacy parameters, tolerance, growth and/or development
- The infant is not a singleton newborn
Trial locations and contacts
1 site in 1 country.
China1 site
Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China: a Double Blind, Multi-center, Randomized, Controlled Trial
The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants.
Read the detailed description
The purpose of this study is to assess the efficacy of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) as compared to standard vegetable oil based infant formula on general gastrointestinal tolerance and fat absorption, reducing calcium soaps formation and stool hardness in Chinese formula-fed term infants.
- Conditions
- Health Behavior, Personal Satisfaction
- Being tested
- InFat™ based infant formula, Standard vegetable oil based infant formula
- Medical subject headings
- Health Behavior, 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 |
|---|---|---|
| InFat group | Active comparator | Infant formula with structured triglycerides (high palmitic acid content at the sn-2 position) Receives: Other: InFat™ based infant formula |
| Control group | Active comparator | Infant formula with standard vegetable blend (low palmitic acid content at the sn-2 position) Receives: Other: Standard vegetable oil based infant formula |
| Referance group | No intervention | Human milk breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis
Measured: 6 postnatal weeks
Secondary outcomes (4)
Anthropometric parameters: body length, body weight, and head circumferences at each visit
Measured: Baseline, 6, 12 and 24 postnatal weeks
Dietary, stool consistency and well being recorded by 3 day questionnaires
Measured: 6, 12 and 24 postnatal weeks
Number of participants with adverse events and concomitant medications as a measure of safety and tolerability
Measured: Baseline, 6,12 and 24 postnatal weeks
Bone speed of sound measured by ultrasonic device at each visit
Measured: Baseline, 6,12 and 24 postnatal weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionMay 2013
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biostime, Inc. (Guangzhou)
- Responsible party
- Sponsor
- Investigators
- Xu Chundix, Prof., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373541
- Sponsor's protocol ID
- InFat_003
- Status last verified
- Jan 2012
- First submitted
- 13 Jun 2011
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bar-Yoseph F, Lifshitz Y, Cohen T, Malard P, Xu C. SN2-Palmitate Reduces Fatty Acid Excretion in Chinese Formula-fed Infants. J Pediatr Gastroenterol Nutr. 2016 Feb;62(2):341-7. doi: 10.1097/MPG.0000000000000971.
PubMed 26334255
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China: a Double Blind, Multi-center, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01373541
- Acronym / sponsor ID
- InFat_003
- Conditions
- Health Behavior, Personal Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- EnzymotecIndustry (pharma, biotech, devices)
- Collaborators
- Biostime, Inc. (Guangzhou)
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Jun 2011 (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 infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants.
Detailed description
The purpose of this study is to assess the efficacy of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) as compared to standard vegetable oil based infant formula on general gastrointestinal tolerance and fat absorption, reducing calcium soaps formation and stool hardness in Chinese formula-fed term 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 |
|---|---|---|
| InFat group | Active comparator | Other: InFat™ based infant formulaInfant formula with structured triglycerides (high palmitic acid content at the sn-2 position) |
| Control group | Active comparator | Other: Standard vegetable oil based infant formulaInfant formula with standard vegetable blend (low palmitic acid content at the sn-2 position) |
| Referance group | No intervention | –Human milk breastfeeding |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parental/legal guardian written informed consent;
- The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants).
- Term infant of Chinese origin born at 37-42 gestation weeks
- Birth weight appropriate for gestational age (AGA), 2500-4000grams
- The infant is apparently healthy at birth and entry of study.
Key exclusion criteria (2 listed)
- Adverse maternal, fetal or infant medical history that can potentially affect efficacy parameters, tolerance, growth and/or development
- The infant is not a singleton newborn
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 group |
| Standard vegetable oil based infant formulaAlso: standard vegetable oilstandard vegetable oil based infant formula | Other | Control group |
Primary outcome
Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis
Time frame: 6 postnatal weeks
4 secondary outcomes
Anthropometric parameters: body length, body weight, and head circumferences at each visit
Time frame: Baseline, 6, 12 and 24 postnatal weeks
Dietary, stool consistency and well being recorded by 3 day questionnaires
Time frame: 6, 12 and 24 postnatal weeks
Number of participants with adverse events and concomitant medications as a measure of safety and tolerability
Time frame: Baseline, 6,12 and 24 postnatal weeks
Bone speed of sound measured by ultrasonic device at each visit
Time frame: Baseline, 6,12 and 24 postnatal 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 13 Feb 2014.
- Derived from this study: PubMed 26334255Bar-Yoseph F, Lifshitz Y, Cohen T, Malard P, Xu C. SN2-Palmitate Reduces Fatty Acid Excretion in Chinese Formula-fed Infants. J Pediatr Gastroenterol Nutr. 2016 Feb;62(2):341-7. doi: 10.1097/MPG.0000000000000971.
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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.
Xu Chundix, Prof. principal investigator
Ruijin Hospital
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 Personal Satisfaction, run by Enzymotec at 1 site in China.
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 5 inclusion and 2 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 13 Feb 2014. 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 China. 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?
Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis (time frame: 6 postnatal 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 NCT01373541, 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 13 Feb 2014.