Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342303
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Activity of Essential Fatty Acid ElongationDesaturation Pathway During Early Life in Human Infants In Vivo
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Essential Fatty Acid Metabolism in the Newborn Equivalence of Precusors and Mediators in the Synthesis of Long Chain Polyunsaturated Fatty Acids of the n-6 and n-3 Series
Status:
COMPLETED
Status Verified Date:
2010-07-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We will test the following hypotheses
1 The activity of the desaturatingelongating enzymes assessed by the in vivo conversion of deuterated a-linolenic and linoleic acids to DHA and AA respectively will be related to the duration of gestation and to postnatal age
2 Dietary w-3 and w-6 LCPUFAs in human milk or DHA and AA supplemented formula will inhibit the desaturationelongation of deuterated a-linolenic and linoleic acids demonstrating in vivo inhibition of the metabolic pathway by respective products
Present evidence suggests that the parent essential fatty acids EFA linoleic acid 182 w-6 and a-linolenic acids 183 w-3 are insufficient to fully satisfy EFA nutrition during early life in the human A possible need for long chain LC longer than 18 C chain length EFAs in the human is suggested by the accretion rates of elongated and desaturated products in the developing fetus the altered plasma and red cell fatty acid patterns and the abnormal visual function observed in infants receiving solely the parent EFAs and by the relatively high concentration of LC EFAs in human milk Most milk formula as compared to human milk are lower in oleic acid higher in linoleic have little a-linolenic acid and virtually no LC w-3 or w-6 polyunsaturated FA LC PUFA This study will evaluate the capacity of human infants to form w-3 and w-6 LCPUFAs from the parent EFAs as affected by developmental stage and dietary EFA supply The precursors will be labeled with deuterium and the products analyzed by gas chromatography mass spectrometry GCMS The main products of the desaturation elongation pathway are docosahexaenoic DHA and arachidonic AA acids for the w-3 and w-6 series respectively Infants will be fed human milk or formulas with or without supplemental LCPUFAs as part of a study to evaluate the effect of EFAs on CNS functional development Infants included in this study of the effect of developmental stage on EFA desaturationelongation will be 2-5 days of age before any fat is administered enterally or parenterally and 28 32 36 or 40 weeks gestation In addition infants born at 28 and 40 weeks gestation will be studied 2 and 6 weeks postnatally after dietary fat has been provided for at least 7 days and energy intake is sufficient to assure growth To evaluate the effect of dietary EFA on DHA and AA formation we will assess elongation desaturation in infants receiving 3 diets human milk which contains w-3 and w-6 LCPUFAs cow milk based formula providing 182 w-6 and 183 w-3 but no LCPUFAs or formula supplemented with added LCPUFAs DHA and AA This study should provide new information on the effects of developmental stage and w-3 and w-6 LCPUFA supply in determining the activity of EFA elongationdesaturation in the human This knowledge may help in improving early neonatal nutritional practices to assure meeting the EFA needs of the developing CNS
1 The activity of the desaturatingelongating enzymes assessed by the in vivo conversion of deuterated a-linolenic and linoleic acids to DHA and AA respectively will be related to the duration of gestation and to postnatal age
2 Dietary w-3 and w-6 LCPUFAs in human milk or DHA and AA supplemented formula will inhibit the desaturationelongation of deuterated a-linolenic and linoleic acids demonstrating in vivo inhibition of the metabolic pathway by respective products
Present evidence suggests that the parent essential fatty acids EFA linoleic acid 182 w-6 and a-linolenic acids 183 w-3 are insufficient to fully satisfy EFA nutrition during early life in the human A possible need for long chain LC longer than 18 C chain length EFAs in the human is suggested by the accretion rates of elongated and desaturated products in the developing fetus the altered plasma and red cell fatty acid patterns and the abnormal visual function observed in infants receiving solely the parent EFAs and by the relatively high concentration of LC EFAs in human milk Most milk formula as compared to human milk are lower in oleic acid higher in linoleic have little a-linolenic acid and virtually no LC w-3 or w-6 polyunsaturated FA LC PUFA This study will evaluate the capacity of human infants to form w-3 and w-6 LCPUFAs from the parent EFAs as affected by developmental stage and dietary EFA supply The precursors will be labeled with deuterium and the products analyzed by gas chromatography mass spectrometry GCMS The main products of the desaturation elongation pathway are docosahexaenoic DHA and arachidonic AA acids for the w-3 and w-6 series respectively Infants will be fed human milk or formulas with or without supplemental LCPUFAs as part of a study to evaluate the effect of EFAs on CNS functional development Infants included in this study of the effect of developmental stage on EFA desaturationelongation will be 2-5 days of age before any fat is administered enterally or parenterally and 28 32 36 or 40 weeks gestation In addition infants born at 28 and 40 weeks gestation will be studied 2 and 6 weeks postnatally after dietary fat has been provided for at least 7 days and energy intake is sufficient to assure growth To evaluate the effect of dietary EFA on DHA and AA formation we will assess elongation desaturation in infants receiving 3 diets human milk which contains w-3 and w-6 LCPUFAs cow milk based formula providing 182 w-6 and 183 w-3 but no LCPUFAs or formula supplemented with added LCPUFAs DHA and AA This study should provide new information on the effects of developmental stage and w-3 and w-6 LCPUFA supply in determining the activity of EFA elongationdesaturation in the human This knowledge may help in improving early neonatal nutritional practices to assure meeting the EFA needs of the developing CNS
Detailed Description:
We will test the following hypotheses
1 The activity of the desaturatingelongating enzymes assessed by the in vivo conversion of deuterated a-linolenic and linoleic acids to DHA and AA respectively will be related to the duration of gestation and to postnatal age
2 Dietary w-3 and w-6 LCPUFAs in human milk or DHA and AA supplemented formula will inhibit the desaturationelongation of deuterated a-linolenic and linoleic acids demonstrating in vivo inhibition of the metabolic pathway by respective products
Present evidence suggests that the parent essential fatty acids EFA linoleic acid 182 w-6 and a-linolenic acids 183 w-3 are insufficient to fully satisfy EFA nutrition during early life in the human A possible need for long chain LC longer than 18 C chain length EFAs in the human is suggested by the accretion rates of elongated and desaturated products in the developing fetus the altered plasma and red cell fatty acid patterns and the abnormal visual function observed in infants receiving solely the parent EFAs and by the relatively high concentration of LC EFAs in human milk Most milk formula as compared to human milk are lower in oleic acid higher in linoleic have little a-linolenic acid and virtually no LC w-3 or w-6 polyunsaturated FA LC PUFA This study will evaluate the capacity of human infants to form w-3 and w-6 LCPUFAs from the parent EFAs as affected by developmental stage and dietary EFA supply The precursors will be labeled with deuterium and the products analyzed by gas chromatography mass spectrometry GCMS The main products of the desaturation elongation pathway are docosahexaenoic DHA and arachidonic AA acids for the w-3 and w-6 series respectively Infants will be fed human milk or formulas with or without supplemental LCPUFAs as part of a study to evaluate the effect of EFAs on CNS functional development Infants included in this study of the effect of developmental stage on EFA desaturationelongation will be 2-5 days of age before any fat is administered enterally or parenterally and 28 32 36 or 40 weeks gestation In addition infants born at 28 and 40 weeks gestation will be studied 2 and 6 weeks postnatally after dietary fat has been provided for at least 7 days and energy intake is sufficient to assure growth To evaluate the effect of dietary EFA on DHA and AA formation we will assess elongation desaturation in infants receiving 3 diets human milk which contains w-3 and w-6 LCPUFAs cow milk based formula providing 182 w-6 and 183 w-3 but no LCPUFAs or formula supplemented with added LCPUFAs DHA and AA Also the relative efficiency of conversion of the 18-C precursors will be compared to the 20-C precursors with respect to their metabolic endpoints This study should provide new information on the effects of developmental stage and w-3 and w-6 LCPUFA supply in determining the activity of EFA elongationdesaturation in the human This knowledge may help in improving early neonatal nutritional practices to assure meeting the EFA needs of the developing CNS
1 The activity of the desaturatingelongating enzymes assessed by the in vivo conversion of deuterated a-linolenic and linoleic acids to DHA and AA respectively will be related to the duration of gestation and to postnatal age
2 Dietary w-3 and w-6 LCPUFAs in human milk or DHA and AA supplemented formula will inhibit the desaturationelongation of deuterated a-linolenic and linoleic acids demonstrating in vivo inhibition of the metabolic pathway by respective products
Present evidence suggests that the parent essential fatty acids EFA linoleic acid 182 w-6 and a-linolenic acids 183 w-3 are insufficient to fully satisfy EFA nutrition during early life in the human A possible need for long chain LC longer than 18 C chain length EFAs in the human is suggested by the accretion rates of elongated and desaturated products in the developing fetus the altered plasma and red cell fatty acid patterns and the abnormal visual function observed in infants receiving solely the parent EFAs and by the relatively high concentration of LC EFAs in human milk Most milk formula as compared to human milk are lower in oleic acid higher in linoleic have little a-linolenic acid and virtually no LC w-3 or w-6 polyunsaturated FA LC PUFA This study will evaluate the capacity of human infants to form w-3 and w-6 LCPUFAs from the parent EFAs as affected by developmental stage and dietary EFA supply The precursors will be labeled with deuterium and the products analyzed by gas chromatography mass spectrometry GCMS The main products of the desaturation elongation pathway are docosahexaenoic DHA and arachidonic AA acids for the w-3 and w-6 series respectively Infants will be fed human milk or formulas with or without supplemental LCPUFAs as part of a study to evaluate the effect of EFAs on CNS functional development Infants included in this study of the effect of developmental stage on EFA desaturationelongation will be 2-5 days of age before any fat is administered enterally or parenterally and 28 32 36 or 40 weeks gestation In addition infants born at 28 and 40 weeks gestation will be studied 2 and 6 weeks postnatally after dietary fat has been provided for at least 7 days and energy intake is sufficient to assure growth To evaluate the effect of dietary EFA on DHA and AA formation we will assess elongation desaturation in infants receiving 3 diets human milk which contains w-3 and w-6 LCPUFAs cow milk based formula providing 182 w-6 and 183 w-3 but no LCPUFAs or formula supplemented with added LCPUFAs DHA and AA Also the relative efficiency of conversion of the 18-C precursors will be compared to the 20-C precursors with respect to their metabolic endpoints This study should provide new information on the effects of developmental stage and w-3 and w-6 LCPUFA supply in determining the activity of EFA elongationdesaturation in the human This knowledge may help in improving early neonatal nutritional practices to assure meeting the EFA needs of the developing CNS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH93-AA-N027 | None | None | None |