Pregnancy RelatedNCT06095232
Pilot Study to Investigate Dietary Changes During Pregnancy
An observational study of Pregnancy Related, run by German Institute of Human Nutrition at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnancy Related
- How many people
- 156 participants
- Where
- 1 siteGermany
- Study dates
- 19 Aug 2023to Aug 2025
- Phase
- Observational
- 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 18 to 35 years
- Women only
- Adult
Study population: Group1: primiparous pregnant women Group2: nulliparous women with a natural menstrual cycle
Who may be able to join
- 18-35 year old healthy women
- Primiparous pregnant women experiencing a singleton pregnancy or nulliparous women who have no pregnancy intention within the next year with a regular menstrual cycle (25-35 days) and no use of hormonal contraceptives in the previous 6 months
- Legally competent/Consent to participate
- Language proficiency in German (native speaker, fluent)
- Physically and mentally healthy
- Body mass index (BMI) of 18.5 - 30 kg/m2 (pre-pregnancy)
Who cannot join
- Former or current illnesses of:
- Brain or mind (including anxiety disorders, depression, eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache, psychiatric or neurological abnormalities)
- Heart or blood circulation/cardiovascular disease (myocardial infarction, stroke, hypertension, hypotension)
- Gastro-intestinal disorders (e.g. colon diseases, irritable bowel syndrome, Crohn's disease)
- endocrine disorders (e.g. thyroid disorders)
- Other serious past or present medical conditions (for example, metabolic syndrome, diabetes).
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Institute of Human Nutrition
Nuthetal, Brandenburg, 14558
About this study
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 longitudinal/cross-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 approach/avoidance 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.
Read the 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 e.g. 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 (3.9 hours) for a total of ca. 15.6 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) H1.1: Higher intake of fat, carbohydrates during late pregnancy compared to naturally cycling women H1.2: Lower intake of vegetables during late pregnancy compared to naturally cycling women H1.3. Higher Dietary Inflammatory Index (DII) during pregnancy compared to naturally cycling women H2: Better inhibition performance during pregnancy compared to naturally cycling women H2.1: Higher executive functioning/memory predicts healthier food choices (more vegetables/fruits, 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 H4.1: Higher implicit food approach behavior towards 'high craving foods' during late vs. early pregnancy H4.2: 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 H5.1: Reduction in risky choices higher in early vs. late pregnancy
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Menstrual cycle, Nutrition, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Primiparous women will participate in the study during the 1st - 3rd trimester of pregnancy and during the postpartum period. | |
| Control group | Nulliparous women with a regular natural menstrual cycle will undergo the same study procedure as pregnant women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food diary
Changes in dietary composition during pregnancy and the menstrual cycle will be assessed using a food diary. This will allow to analyse food composition based on macronutrients and compare protein, fat and carbohydrate consumption across different time points.
Measured: 3 days during 4 study appointments (in ca. 12 months)
Avoidance/approach behavior (food stimuli, baby vs. adult pictures)
Participants will undergo an online avoidance approach task in which images are either visually increased or decreased, based on the instruction. In a first trial food images are presented based on craving ratings. The second part consists of pictures of babies and adults assessing possible changes in approach avoidance tendencies to baby stimuli in pregnant women.
Measured: 4 study appointments (in ca. 12 months)
Inhibitory control
Inhibitory control will be assessed using a go/no-go task. Go trials will be presented 80% of the time, in an arrow either pointing towards the right or left is presented. Participants have to respond by pressing either right or left, matching the stimulus presentation. 20% of the time a stop signal (xx) will be presented, requiring no button press from participants.
Measured: 4 study appointments (in ca. 12 months)
Risk and decision-making
Participants will make choices in a lottery task based on risky vs safe options. Risky options are less likely but associated with higher fictional monetary rewards whereas safe options occur with a high likelihood and are associated with less monetary rewards.
Measured: 4 study appointments (in ca. 12 months)
Processing speed
In a digit substitution task, a table with symbols and matching numbers is displayed. For one chosen symbol participants have to indicate the matching symbol as quickly as possible. In order to avoid memory effects, the ordering of symbols and numbers is changed in each trial.
Measured: 4 study appointments (in ca. 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start19 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Soyoung Q Park, German Institute of Human Nutrition
- Investigators
- Soyoung Q Park, Prof. Dr., Principal investigator, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095232
- Sponsor's protocol ID
- Pregnancy and dietary changes
- Status last verified
- Oct 2023
- First submitted
- 1 Aug 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate Dietary Changes During Pregnancy
- ClinicalTrials.gov ID
- NCT06095232
- Acronym / sponsor ID
- Pregnancy and dietary changes
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Menstrual cycle, Nutrition, Cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Study start
- 19 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- 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 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 longitudinal/cross-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 approach/avoidance 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 e.g. 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 (3.9 hours) for a total of ca. 15.6 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) H1.1: Higher intake of fat, carbohydrates during late pregnancy compared to naturally cycling women H1.2: Lower intake of vegetables during late pregnancy compared to naturally cycling women H1.3. Higher Dietary Inflammatory Index (DII) during pregnancy compared to naturally cycling women H2: Better inhibition performance during pregnancy compared to naturally cycling women H2.1: Higher executive functioning/memory predicts healthier food choices (more vegetables/fruits, 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 H4.1: Higher implicit food approach behavior towards 'high craving foods' during late vs. early pregnancy H4.2: 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 H5.1: Reduction in risky choices higher in early vs. late pregnancy
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Primiparous women will participate in the study during the 1st - 3rd trimester of pregnancy and during the postpartum period. |
| Control group | – | –Nulliparous women with a regular natural menstrual cycle will undergo the same study procedure as pregnant women. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Group1: primiparous pregnant women Group2: nulliparous women with a natural menstrual cycle
Key inclusion criteria (6 listed)
- 18-35 year old healthy women
- Primiparous pregnant women experiencing a singleton pregnancy or nulliparous women who have no pregnancy intention within the next year with a regular menstrual cycle (25-35 days) and no use of hormonal contraceptives in the previous 6 months
- Legally competent/Consent to participate
- Language proficiency in German (native speaker, fluent)
- Physically and mentally healthy
Key exclusion criteria (6 listed)
- Brain or mind (including anxiety disorders, depression, eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache, psychiatric or neurological abnormalities)
- Heart or blood circulation/cardiovascular disease (myocardial infarction, stroke, hypertension, hypotension)
- Gastro-intestinal disorders (e.g. colon diseases, irritable bowel syndrome, Crohn's disease)
- endocrine disorders (e.g. thyroid disorders)
- Other serious past or present medical conditions (for example, metabolic syndrome, diabetes).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Food diary
Time frame: 3 days during 4 study appointments (in ca. 12 months)
Changes in dietary composition during pregnancy and the menstrual cycle will be assessed using a food diary. This will allow to analyse food composition based on macronutrients and compare protein, fat and carbohydrate consumption across different time points.
Avoidance/approach behavior (food stimuli, baby vs. adult pictures)
Time frame: 4 study appointments (in ca. 12 months)
Participants will undergo an online avoidance approach task in which images are either visually increased or decreased, based on the instruction. In a first trial food images are presented based on craving ratings. The second part consists of pictures of babies and adults assessing possible changes in approach avoidance tendencies to baby stimuli in pregnant women.
Inhibitory control
Time frame: 4 study appointments (in ca. 12 months)
Inhibitory control will be assessed using a go/no-go task. Go trials will be presented 80% of the time, in an arrow either pointing towards the right or left is presented. Participants have to respond by pressing either right or left, matching the stimulus presentation. 20% of the time a stop signal (xx) will be presented, requiring no button press from participants.
Risk and decision-making
Time frame: 4 study appointments (in ca. 12 months)
Participants will make choices in a lottery task based on risky vs safe options. Risky options are less likely but associated with higher fictional monetary rewards whereas safe options occur with a high likelihood and are associated with less monetary rewards.
Processing speed
Time frame: 4 study appointments (in ca. 12 months)
In a digit substitution task, a table with symbols and matching numbers is displayed. For one chosen symbol participants have to indicate the matching symbol as quickly as possible. In order to avoid memory effects, the ordering of symbols and numbers is changed in each trial.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
Soyoung Q Park, Prof. Dr. principal investigator
German Institute of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by German Institute of Human Nutrition at 1 site in Germany.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Rehbein, Dr. (+4933200882525, elisa.rehbein@dife.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food diary (time frame: 3 days during 4 study appointments (in ca. 12 months)). The study lists 5 primary outcomes in all. 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 23 Oct 2023.