HealthyPhase 4NCT00480948
Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants
A Phase 4 study testing Infant formula feeding (InFat™) in people with Healthy, run by Enzymotec at 1 site in China.
Trial summary
The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants. Read more about this study
- Who is it for?
- Ages 1 day to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Infant formula feeding (InFat™)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Aug 2009
- Phase
- Phase 4
- 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 8 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infants: gestation 37-40 weeks
- Birth weight 2500-4000 g
- Apparent good health
- The infant is a product of normal pregnancy and delivery.
Who cannot join
- Any maternal disease (psychological or disabled) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
- Major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth, clinically significant
- Disease requiring mechanical ventilation or medication treatment at the first week (not including photo treatment for infantile hepatitis)
- Born with a 5- or 10-minute Apgar score <7
- Any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
- Breast-feeding for a week or over.
- 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: Effects of InFat™ Product (High Sn-2 Palmitic Acid) on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants: a Triple-blind, Randomized, Placebo-controlled Trial
The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.
Read the detailed description
In human breast milk, and in most infant formulas more than 98% of this milk fat is in the form of triglycerides, which contain saturated and unsaturated fatty acids esterified to glycerol. Fatty acids in human milk-fat have a highly specific positional distribution on the glycerol backbone and this specific configuration is known to have a major contribution to the efficacy of this nutrient absorption.
Palmitic acid (C16:0), the major saturated fatty acid, is predominantly esterified to the sn-2 (β) position of the triglyceride in human milk. In contrast, palmitic acid in standard infant formulas is esterified to the sn-1 and sn-3 positions.
Infants fed with high sn-2 palmitic acid formula had softer stools, less constipation and better calcium absorption as compared to standard infant formula.
InFat™ is structured triglyceride fat ingredient with high levels of palmitic acid at sn-2 position.
The primary objective of this trial is to demonstrate that feeding Chinese term infants, with formula having proportion of palmitate in the sn-2 position comparable to human milk, reduces calcium-soaps formation.
- Conditions
- Healthy
- Being tested
- Infant formula feeding (InFat™), Control
- Keywords
- infant, infant formula, fatty acids, palmitic acid, stool, calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formula feeding (InFat™)Behavioural
Infant formula with InFat™ oil (containing ~49% of C16:0 at sn-2 position), 24 wk
ControlDietary supplement
Standard vegetable oil based infant formula
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Infant formula with InFat™ oil(containing ~49% of C16:0 at sn-2 position). Receives: Behavioral: Infant formula feeding (InFat™) |
| 2 | Placebo comparator | Standard vegetable oil based infant formula Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool biochemistry - soaped fatty acids
Measured: 6 weeks
Secondary outcomes (4)
Stool biochemistry - total fatty acids and calcium content
Measured: 6 weeks
Stool characteristics - 7days diaries
Measured: 3 months
General health
Measured: 3 months
Anthropometric parameters
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startSep 2008
- Primary completionApr 2009
- Study completionAug 2009
Why it stopped: Study design changes were needed due to change of protocol to a multisite trial and updated set up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enzymotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yi Xiang Su, MD Professor, Principal investigator, Sun Yat-sen UniversityYuming Chen, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480948
- Sponsor's protocol ID
- InFat™001
- Status last verified
- Aug 2008
- First submitted
- 30 May 2007
- Last updated
- 7 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of InFat™ Product (High Sn-2 Palmitic Acid) on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants: a Triple-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00480948
- Acronym / sponsor ID
- InFat™001
- Conditions
- Healthy
- Keywords
- infant, infant formula, fatty acids, palmitic acid, stool, calcium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study design changes were needed due to change of protocol to a multisite trial and updated set up
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- EnzymotecIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 31 May 2007 (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 demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.
Detailed description
In human breast milk, and in most infant formulas more than 98% of this milk fat is in the form of triglycerides, which contain saturated and unsaturated fatty acids esterified to glycerol. Fatty acids in human milk-fat have a highly specific positional distribution on the glycerol backbone and this specific configuration is known to have a major contribution to the efficacy of this nutrient absorption.
Palmitic acid (C16:0), the major saturated fatty acid, is predominantly esterified to the sn-2 (β) position of the triglyceride in human milk. In contrast, palmitic acid in standard infant formulas is esterified to the sn-1 and sn-3 positions.
Infants fed with high sn-2 palmitic acid formula had softer stools, less constipation and better calcium absorption as compared to standard infant formula.
InFat™ is structured triglyceride fat ingredient with high levels of palmitic acid at sn-2 position.
The primary objective of this trial is to demonstrate that feeding Chinese term infants, with formula having proportion of palmitate in the sn-2 position comparable to human milk, reduces calcium-soaps formation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Infant formula feeding (InFat™)Infant formula with InFat™ oil(containing ~49% of C16:0 at sn-2 position). |
| 2 | Placebo comparator | Dietary Supplement: ControlStandard vegetable oil based infant formula |
Who may qualify
- Ages
- 1 day to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Term infants: gestation 37-40 weeks
- Birth weight 2500-4000 g
- Apparent good health
- The infant is a product of normal pregnancy and delivery.
Key exclusion criteria (7 listed)
- Any maternal disease (psychological or disabled) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
- Major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth, clinically significant
- Disease requiring mechanical ventilation or medication treatment at the first week (not including photo treatment for infantile hepatitis)
- Born with a 5- or 10-minute Apgar score <7
- Any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
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 |
|---|---|---|
| Infant formula feeding (InFat™)Infant formula with InFat™ oil (containing ~49% of C16:0 at sn-2 position), 24 wk | Behavioural | 1 |
| ControlStandard vegetable oil based infant formula | Dietary supplement | 2 |
Primary outcome
Stool biochemistry - soaped fatty acids
Time frame: 6 weeks
4 secondary outcomes
Stool biochemistry - total fatty acids and calcium content
Time frame: 6 weeks
Stool characteristics - 7days diaries
Time frame: 3 months
General health
Time frame: 3 months
Anthropometric parameters
Time frame: 3-6 months
Results and safety
The study was stopped early (reason given: Study design changes were needed due to change of protocol to a multisite trial and updated set up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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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.
Yi Xiang Su, MD Professor principal investigator
Sun Yat-sen University
Yuming Chen, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infant formula feeding (InFat™) in people with Healthy, 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 7 Jun 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study design changes were needed due to change of protocol to a multisite trial and updated set up). Results are not available in the source record.
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?
Stool biochemistry - soaped fatty acids (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2011.