Pilot Study to Investigate Dietary Changes During Pregnancy

NCT06095232 | Unknown

• 1 other identifier: Pregnancy and dietary changes
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pregnancy Related

Keywords

Pregnancy; Menstrual cycle; Nutrition; Cognition

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  4 study appointments (in ca. 12 months)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Group1: primiparous pregnant women Group2: nulliparous women with a natural menstrual cycle

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• German Institute of Human Nutrition: lead

Study Sites (1)

German Institute of Human Nutrition

Nuthetal, Brandenburg, 14558, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample (in order to analyse microbiome data)

Study Officials

• Soyoung Q Park, Prof. Dr.

  German Institute of Human Nutrition

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Rehbein, Dr.

CONTACT

+4933200882525; elisa.rehbein@dife.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department Decision making and Nutrition (DNN)

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: October 23, 2023
• Study Start: August 19, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

DE (1)