Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519071
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-08-02
Brief Title:
Tryptophan Requirements During Pregnancy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Determining Dietary Tryptophan Requirements In Healthy Pregnant Women Using The Indicator Amino Acid Oxidation Method
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pregnancy is an important period of life where there is an increased need for nutrients including protein and amino acids from food The current protein and amino acids dietary recommendations were all established using older methods done in adult men Then protein and amino acids requirements for all stages of pregnancy were calculated without accounting for changing demands in each trimester Therefore another more precise method is needed to better understand how much amino acids in this study tryptophan women need during pregnancy
In the current study the investigators are going to apply the Indicator Amino Acid Oxidation IAAO method to measure the dietary tryptophan needs in a healthy pregnancy This method is a noninvasive quick and reliable technique that uses a stable isotope-labeled amino acid The stable isotope tracer is a labeled amino acid which is colorless odorless tasteless and completely safe they are present in the air water and food Amino acids are mostly made of Carbon-12 12C whereas the isotope tracer contains Carbon-13 13C The tracer can be detected in breath and urine samples with special equipment because it looks different than the rest of the amino acids in the body In Elango lab the investigators have done similar studies using the same technique in children nonpregnant women and pregnant women This will allow us to measure tryptophan needs in pregnancy
In the current study the investigators are going to apply the Indicator Amino Acid Oxidation IAAO method to measure the dietary tryptophan needs in a healthy pregnancy This method is a noninvasive quick and reliable technique that uses a stable isotope-labeled amino acid The stable isotope tracer is a labeled amino acid which is colorless odorless tasteless and completely safe they are present in the air water and food Amino acids are mostly made of Carbon-12 12C whereas the isotope tracer contains Carbon-13 13C The tracer can be detected in breath and urine samples with special equipment because it looks different than the rest of the amino acids in the body In Elango lab the investigators have done similar studies using the same technique in children nonpregnant women and pregnant women This will allow us to measure tryptophan needs in pregnancy
Detailed Description:
Pre-Study
All participants will arrive following a 10-12 hrs overnight fasting to allow the anthropometric measurements biochemical and dietary assessments Fasting blood glucose by finger prick will be used to screen for gestational diabetes The presence of protein glucose ketones leukocytes and blood in urine will be assessed using urinalysis strips as potential indicators of gestational diabetes and preeclampsia For the anthropometric assessment weight and height will be measured and body composition will be determined using skinfold thickness measurements and Bioelectrical Impedance Analysis BIA A brief medical history will be obtained to screen for medication use substance use previous pregnancies and overall health For the dietary assessment energy requirements will be determined using Resting Energy Expenditure REE by continuous open-circuit indirect calorimetry In addition to two-days detailed dietary records to estimate participants calorie protein and tryptophan intake
Study Day
Participants are expected to arrive following a 10-12 hrs overnight fasting as mentioned above anthropometric measurements fasting blood glucose testing and urine strip analysis will be repeated at the beginning of each study day On the study day the investigator will randomly assign the participant a test tryptophan intake ranging between 1 to 14 mgkgd and will receive an 8-hourly isocaloric and isonitrogenous meal Based on Resting Energy Expenditure determined during the pre-study day each meal will provide daily adequate energy and adequate protein at 15 gkgd to ensure that the Indicator Amino Acid Oxidation IAAO response is due to the different test tryptophan intakes and not from the limited energy andor protein During the study days participants will be allowed to have the prepared study diets and water only
Sample Collection
Three baseline breath samples will be collected at 45 30 and 15 min before isotope infusion Thereafter isotope administration meal 5 - 8 breath samples will be collected at 150 180 195 210 225 and 240 min during the metabolic steady state Urine samples will be collected at 45 min before isotope infusion meal 5 and two samples at 180 and 240 min after the tracer infusion One blood sample will be collected to measure tryptophan and four related metabolites within the kynurenine and serotonin pathway plasma kynurenine xanthurenic acid quinolinic acid and serotonin and B vitamins plasma B6 B12 and B9 then compared between early and later stages of gestation in response to different tryptophan intakes
All participants will arrive following a 10-12 hrs overnight fasting to allow the anthropometric measurements biochemical and dietary assessments Fasting blood glucose by finger prick will be used to screen for gestational diabetes The presence of protein glucose ketones leukocytes and blood in urine will be assessed using urinalysis strips as potential indicators of gestational diabetes and preeclampsia For the anthropometric assessment weight and height will be measured and body composition will be determined using skinfold thickness measurements and Bioelectrical Impedance Analysis BIA A brief medical history will be obtained to screen for medication use substance use previous pregnancies and overall health For the dietary assessment energy requirements will be determined using Resting Energy Expenditure REE by continuous open-circuit indirect calorimetry In addition to two-days detailed dietary records to estimate participants calorie protein and tryptophan intake
Study Day
Participants are expected to arrive following a 10-12 hrs overnight fasting as mentioned above anthropometric measurements fasting blood glucose testing and urine strip analysis will be repeated at the beginning of each study day On the study day the investigator will randomly assign the participant a test tryptophan intake ranging between 1 to 14 mgkgd and will receive an 8-hourly isocaloric and isonitrogenous meal Based on Resting Energy Expenditure determined during the pre-study day each meal will provide daily adequate energy and adequate protein at 15 gkgd to ensure that the Indicator Amino Acid Oxidation IAAO response is due to the different test tryptophan intakes and not from the limited energy andor protein During the study days participants will be allowed to have the prepared study diets and water only
Sample Collection
Three baseline breath samples will be collected at 45 30 and 15 min before isotope infusion Thereafter isotope administration meal 5 - 8 breath samples will be collected at 150 180 195 210 225 and 240 min during the metabolic steady state Urine samples will be collected at 45 min before isotope infusion meal 5 and two samples at 180 and 240 min after the tracer infusion One blood sample will be collected to measure tryptophan and four related metabolites within the kynurenine and serotonin pathway plasma kynurenine xanthurenic acid quinolinic acid and serotonin and B vitamins plasma B6 B12 and B9 then compared between early and later stages of gestation in response to different tryptophan intakes
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