Effects of Diet on Perinatal Mood and Cognition

NCT05890014 | Active Not Recruiting

• 1 other identifier: UReading mothers study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The baby blues are a significant event which can occur immediately following childbirth and is a normal experience occurring in up to 76% of new mothers, characterised by mood swings, irritability and sadness typically lasting 10-14 days. Research suggests that the more severe and longer duration of the baby blues, the higher risk of later postnatal mood disorders. Therefore, this represents a critical period which could benefit from an intervention which may prevent symptom onset or an increase in the severity of mood disorders later in the postpartum. Evidence suggests that consumption of flavonoid rich foods can improve physical health, mood and cognition. Prior research investigating flavonoid intervention in mothers in the first 6 months and 1 year postpartum found significant benefits to mood in the new mothers after daily flavonoid supplementation, showing promise for the management of mood in a key period for mothers, where risk of Postnatal Depression (PND) is high. The immediate postpartum also represents a period of cognitive changes reported to affect up to 80% of new mothers. In addition, women during this time are at an increased risk of high blood pressure and hypertension, which is thought to be a risk factor for the onset and severity of depressive symptoms and cognitive decrements. Flavonoids have been reported to improve cognition and cardiovascular health, therefore, introducing a flavonoid intervention could have benefits to cognition and blood pressure in new mothers. The aim of the current study will be to explore whether the implementation of a high flavonoid diet across a 30-day period will positively affect maternal mental health, cognition and blood pressure. Participants will be assigned to one of three groups; high or low flavonoid diet or a control condition for 30-days, starting at days 0-4 after birth. They will have visits from the researcher at 6 separate time points between the third trimester and 12 weeks postpartum. At each visit, participants will be asked to complete mood questionnaires (PANAS-NOW), Edinburgh Postnatal Depression Scale (EPDS), Postpartum Specific Anxiety Scale (PSAS), State-Trait Anxiety Inventory (STAI), Edinburgh Postnatal Depression Scale- Partner (EPDS-P) followed by a cognitive battery (MANT, RAVLT, PRMQ) and blood pressure recordings (systolic and diastolic blood pressure). Between visits, participants will be contacted by the researcher to record retrospective 24hr food recalls (Intake24).

Conditions

Mood; Mothers; Healthy

Keywords

Cognition; Mood; Flavonoids; Diet; Postpartum; Blood pressure

Outcome Measures

Primary Outcomes (8)

• Mean depressive symptoms

  Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.

  Days 0-4 postpartum

• Mean depressive symptoms

  Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.

  2 weeks postpartum

• Mean depressive symptoms

  Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.

  4 weeks postpartum

• Mean depressive symptoms

  Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.

  12 weeks postpartum

• Mean state anxiety

  Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.

  Days 0-4 postpartum

• Mean state anxiety

  Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.

  2 weeks postpartum

• Mean state anxiety

  Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.

  4 weeks postpartum

• Mean state anxiety

  Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.

  12 weeks postpartum

Secondary Outcomes (37)

• Mean postpartum-specific anxiety symptoms

  Days 0-4 postpartum

• Mean postpartum-specific anxiety symptoms

  2 weeks postpartum

• Mean postpartum-specific anxiety symptoms

  4 weeks postpartum

• Mean postpartum-specific anxiety symptoms

  12 weeks postpartum

• Mean current affect

  Days 0-4 postpartum

Other Outcomes (4)

• General diet

  Baseline only

• 24-hr dietary recall

  Pregnancy (up to 10 weeks before birth date)

• 24-hr dietary recall

  Postpartum during intervention (up to 34 days after birth)

Study Arms (3)

High flavonoid group

EXPERIMENTAL

Participants will be encouraged to consume 2 x flavonoid-rich food items per day from the following list of flavonoid-rich foods across 30-days, above what they already consume each day, typically. Orange juice (190 mls) Grapefruit juice (169mls) Dark chocolate (64g) Spinach (109g) Blueberry (64g) Strawberry (157g) Blackberry (81g) Blackcurrant (61g) Cherries (182g) Plums (90g) Black grapes (142g) Oranges (247g) Black olives (89g) Red grapes (339g)

Dietary Supplement: Flavonoid-rich diet

Low flavonoid group

EXPERIMENTAL

Participants will be encouraged to consume 1 x flavonoid-rich food items per day from the following list of flavonoid-rich foods across 30-days, above what they already consume each day, typically. Orange juice (190 mls) Grapefruit juice (169mls) Dark chocolate (64g) Spinach (109g) Blueberry (64g) Strawberry (157g) Blackberry (81g) Blackcurrant (61g) Cherries (182g) Plums (90g) Black grapes (142g) Oranges (247g) Black olives (89g) Red grapes (339g)

Dietary Supplement: Flavonoid-rich diet

Control

NO INTERVENTION

Participants will be given no instructions regarding adding food items to their diet. They will be encouraged to continue their diet as normal for 30-days.

Interventions

Flavonoid-rich diet DIETARY_SUPPLEMENT

Inclusion of foods rich in flavonoids.

High flavonoid group; Low flavonoid group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be pregnant (reliant on mothers' self-reporting)

You may not qualify if:

• Participants beyond 38 weeks of their pregnancy (reliant on mothers' self reporting)

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

University of Reading

Reading, Berkshire, RG66AL, United Kingdom

Location

Study Officials

• Daniel Lamport, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators who process, score and analyse data will be masked
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Dr Daniel Lamport

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 5, 2023
• Study Start: March 14, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)