Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095232
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-08-01
Brief Title:
Pilot Study to Investigate Dietary Changes During Pregnancy
Sponsor:
German Institute of Human Nutrition
Organization:
German Institute of Human Nutrition
Study Overview
Official Title:
Pilot Study to Investigate Dietary Changes During Pregnancy
Status:
RECRUITING
Status Verified Date:
2023-10
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:
The aim of this pilot study is to investigate dietary choices and composition during pregnancy and fluctuating sex hormones during the natural menstrual cycle in women In particular the investigators are interested in the relationship between diet choice cognitive performance and diversity of the gut microbiome
The study will be conducted in a longitudinalcross-sectional design Primiparous pregnant women will be investigated during four different time periods during the 1st-3rd trimester and during the postpartum period Women with a natural regular menstrual cycle will be assessed during two different hormonal phases of the cycle early follicular luteal and undergo the same study design as pregnant women Participants will conduct online tasks related to cognitive performance food approachavoidance behavior and risk assessment fill out online questionnaires related to diet mood sleep and mental-wellbeing In addition participants will log their daily food intake for three days in a food diary and send in a stool sample in order to analyse gut microbiome composition
The study will be conducted in a longitudinalcross-sectional design Primiparous pregnant women will be investigated during four different time periods during the 1st-3rd trimester and during the postpartum period Women with a natural regular menstrual cycle will be assessed during two different hormonal phases of the cycle early follicular luteal and undergo the same study design as pregnant women Participants will conduct online tasks related to cognitive performance food approachavoidance behavior and risk assessment fill out online questionnaires related to diet mood sleep and mental-wellbeing In addition participants will log their daily food intake for three days in a food diary and send in a stool sample in order to analyse gut microbiome composition
Detailed Description:
Before the beginning of the study participants will undergo a screening process related to inclusion and exclusion criteria Upon successful study inclusion the procedure for each study session and both study groups will follow the same order On Day1 of each time point participants will fill out a browser-based segment which includes questionnaires related to eg affect food intake sleep and cognition approximately 60 minutes and are asked to complete four browser-based online tasks including and Approach Avoidance Task Risk Decision Task Stop Signal Task Digit-Substitution Task approximately 44 minutes The app-based segment will be completed during three days Days 2-4 The timing of this will vary by participant but takes on average 30 minutes per day for three days These sessions will take place once each trimester and once during postpartum Therefore each collection period will take approximately 234 minutes 39 hours for a total of ca 156 hours per participant
The investigators will test the following hypotheses
H1 Differences in food intake across the course of pregnancy with a decrease in healthy food choices vegetables fruits and an increase in carbohydrates and fat high craving foods H11 Higher intake of fat carbohydrates during late pregnancy compared to naturally cycling women H12 Lower intake of vegetables during late pregnancy compared to naturally cycling women H13 Higher Dietary Inflammatory Index DII during pregnancy compared to naturally cycling women H2 Better inhibition performance during pregnancy compared to naturally cycling women H21 Higher executive functioningmemory predicts healthier food choices more vegetablesfruits less fat and sugar intake H3 Worse food-related memory performance during pregnancy and the postpartum period compared to naturally cycling women H4 Higher implicit food approach tendencies towards high craving foods during pregnancy than the postpartum period and naturally cycling women H41 Higher implicit food approach behavior towards high craving foods during late vs early pregnancy H42 Higher implicit food approach behavior is related to food intake of high craving foods carbohydrates fat H5 Higher risk aversion less risky choices during pregnancy compared to naturally cycling women H51 Reduction in risky choices higher in early vs late pregnancy
The investigators will test the following hypotheses
H1 Differences in food intake across the course of pregnancy with a decrease in healthy food choices vegetables fruits and an increase in carbohydrates and fat high craving foods H11 Higher intake of fat carbohydrates during late pregnancy compared to naturally cycling women H12 Lower intake of vegetables during late pregnancy compared to naturally cycling women H13 Higher Dietary Inflammatory Index DII during pregnancy compared to naturally cycling women H2 Better inhibition performance during pregnancy compared to naturally cycling women H21 Higher executive functioningmemory predicts healthier food choices more vegetablesfruits less fat and sugar intake H3 Worse food-related memory performance during pregnancy and the postpartum period compared to naturally cycling women H4 Higher implicit food approach tendencies towards high craving foods during pregnancy than the postpartum period and naturally cycling women H41 Higher implicit food approach behavior towards high craving foods during late vs early pregnancy H42 Higher implicit food approach behavior is related to food intake of high craving foods carbohydrates fat H5 Higher risk aversion less risky choices during pregnancy compared to naturally cycling women H51 Reduction in risky choices higher in early vs late pregnancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None