NCT06402916

Brief Summary

Blueberries are an excellent source of natural substances (flavonoids) with well-documented health benefits. Previous research has shown that consuming a serving of blueberries can improve mood in children, healthy young adults, and young adults with depressive symptoms. These results are consistent with a growing body of evidence from human and animal studies indicating that blueberries can have a beneficial effect on brain function and mental health. The postpartum period represents a challenging period whereby mood disorders such as postpartum depression become increasingly prevalent, in addition to this, mothers and fathers often report poorer cognition during this time. Therefore, it is of interest to explore whether acute blueberry supplementation can benefit mood and cognition for parents during this sensitive time. The aim of the present study is to examine whether consuming a drink containing powdered blueberries can improve mood and cognition in parents in the 0-6 month postpartum. The design follows a randomised, double blind, placebo controlled cross over design. Participants will be invited to take part in an in-person study investigating a fruit drink on mood and cognition. Participants will come to the Nutrition-cognition lab at the Psychology department at the University of Reading for a screening session, after providing informed consent, participants will return a week later to attend a 3-hr visit during which they will receive either a blueberry or placebo drink and complete computer tasks and standardised questionnaires. Participants will then return a week later and complete the same procedure, consuming the other intervention drink.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

May 2, 2024

Last Update Submit

May 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean current affect

    Assessed using scores from the Positive and Negative Affect Scale. This questionnaire has 20 items that describe some feelings and emotions. The participant needs to mark how much they are experiencing these feelings on a scale from 1-5. This produces scores of Positive Affect and Negative Affect; higher scores reflect higher positive or negative mood, respectively.

    2 hours post ingestion

Secondary Outcomes (7)

  • Mean state anxiety

    2 hours post ingestion

  • Mean subjective mood scores

    2 hours post ingestion

  • Blood pressure

    2 hours post ingestion

  • Mean subjective feelings

    2 hours post ingestion

  • Verbal memory

    2 hours post ingestion

  • +2 more secondary outcomes

Other Outcomes (10)

  • General diet

    Screening

  • Subjective sleep scores

    Baseline

  • Mean postpartum-specific anxiety symptoms

    Screening

  • +7 more other outcomes

Study Arms (2)

Blueberry drink

EXPERIMENTAL

46g freeze-dried wild blueberry (Vaccinium angustifolium) powder mixed with 250 ml water.

Dietary Supplement: Blueberry drink

Placebo drink

PLACEBO COMPARATOR

46g placebo powder matched for macronutrients, color, and flavor mixed with 250 ml water.

Dietary Supplement: Placebo drink

Interventions

Blueberry drinkDIETARY_SUPPLEMENT

Blueberry drink equivalent to 240g fresh blueberries.

Blueberry drink
Placebo drinkDIETARY_SUPPLEMENT

Drink containing no active ingredient.

Placebo drink

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be a biological mother or father to an infant aged 0-6 months.
  • Have a good understanding of English language

You may not qualify if:

  • Allergic to blueberries or any other Vaccinium species
  • Participation in other interventional studies within the last month
  • Participants with cancer, or conditions affecting the liver, heart or kidneys due to unknown effects on flavonoid metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Daniel Lamport

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 7, 2024

Study Start

May 20, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Anonymized data may be made available on a platform such as Open Science Framework (www.osf.io) or a data repository linked to academic journals, in accordance with Open Science principles.