search
Back to results

Snack Foods and Their Impact on Mental Health and the Gut-brain Axis (NutriMood)

Primary Purpose

Depression, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intervention snack
Control Snack
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Mental health, Gut-Brain Axis, Depression, Anxiety, Nutrition, Gut Microbiome

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults aged 18-45 years old. Body mass index (BMI) between 18.50-29.99kg/m2 Score 10-29 on the patient health questionnaire anxiety and depression scale (PHQ-ADS) for mild to moderate symptoms of depression and anxiety. Individuals who regularly consume snacks (Classified as ≥2 per day excluding fruit, vegetable, nut and seed snacks). Willing to complete the 12-week intervention by adhering to snacks, complete mental health questionnaires, provide stool and blood samples, record weight and other anthropometric values and record food intake at various timepoints throughout the intervention. Willing to adhere to the protocol and provide informed consent. Fibre intake of <30g/d Willing to discontinue use of pre and probiotics during the trial. Exclusion Criteria: Dislike of intervention products. Allergy or intolerance to the intervention products Self-report occurrence of substance dependency or severe mental health conditions (e.g., psychosis, schizophrenia, eating disorder). Those with depressive disorders or anxiety disorders will be included in the trial providing they meet all other inclusion criteria. Regular consumption of experimental product as snacks and unwilling to complete a washout (no consumption for 4 weeks before baseline or during the study period). Changes to medication for depression or anxiety within the last 3 months (e.g., dosage, frequency, type) Initiation of any new medications for mental health or any form of talk therapy within the last 3 months. Intention to start or alter medication or therapy for mental health during the study. Current or previous antibiotic treatment within 4 weeks prior to the start of the study. Consumption of probiotics or prebiotic products within the 2 weeks prior to the start of the study Women who are pregnant, lactating or planning pregnancy Unexplained or unintentional weight loss in the past six months Medical history of any of the following: diabetes, major active or historic psychiatric conditions (e.g. schizophrenia), current eating disorder, alcohol abuse, active treatment for cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary disease (or any other chronic medical condition), severe oesophagitis, gastritis or duodenitis, active diverticulitis or intestinal/colonic strictures, Coeliac disease, Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection surgery (excluding appendicectomy and cholecystectomy), bleeding disorder, anaphylaxis or any other major or chronic condition known to impact study outcome measures.

Sites / Locations

  • Metabolic research unit, Franklin-Wilkins Building, 150 stamford street

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control snack

Experimental snack

Arm Description

42 participants will be randomly assigned to the control snack. Snacks should be consumed twice per day, once as a mid-morning snack and again as a mid-afternoon snack.

42 participants (50%) will be randomly assigned to snack on the intervention snack. Snacks should be consumed twice per day, once as a mid-morning snack and again as a mid-afternoon snack.

Outcomes

Primary Outcome Measures

Symptoms of depression and anxiety
Symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.

Secondary Outcome Measures

Functional impairment
The self-report Work and social adjustment scale (WSAS) will be used to measure functional impairment scores. This is a self-report likert scale with 5 questions. Responses range from Not at all (0) to Very severely (8). 0-9, 10-19 and 20-40 represent low, moderate and severe impairment respectively.
Sleep quality
The self-report Pittsburgh sleep quality index (PSQI) will be used to measure sleep quality. This is a 19-item questionnaire with seven subcategories; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Wellbeing
The self-report world health organisation five well-being index (WHO-5) will be used to measure wellbeing. The scale consists of 5 items rated from All of the time (5) to At no time (0).
Quality of life
The self-report World Health Organisation Quality of Life Brief (WHOQOL-BREF) scale will be used to measure quality of life. This is a 26-item scale. Responses are rated on a 1-5 likert scale with 1 representing 'not at all' and 5 representing 'completely agree'. Scores are tabulated and multiplied by 4 to represent a score out of 100.
Physical activity
The self-report international Physical Activity Questionnaire - Short form (IPAQ) will be used to measure physical activity.
Symptoms of depression
The self-report Patient Health Questionnaire-8 (PHQ-8) will be used to measure symptoms of depression. The PHQ-8 is comprised of 8 items rated 0 to 3 with 0 representing 'not at all' and 3 representing 'nearly every day'.
Symptoms of anxiety
The self-report Generalised Anxiety disorder-7 scale will be used to measure symptoms of anxiety. The GAD-7 is comprised of 7 questions rated 0 to 3 indicating not at all, to nearly every day respectively.
Psychological Distress
The Kessler Psychological Distress Scale (K10) will be used to measure symptoms of psychological distress. The K10 is comprised of 10 questions rated on a 5-point likert scale. Scores range from 10-50.
Faecal gut microbiota (composition, alpha- and beta-diversity)
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples.
Faecal short-chain fatty acids (SCFA)
Measured by gas liquid chromatography of stool samples
Faecal water
Determined from stool samples by oven-drying
Gut symptoms
Measured using the Gastrointestinal Symptom Rating Scale (GSRS) (7-day diary; questionnaire)
Stool frequency
Measured using self-reported number bowel movements daily recorded in a 7-day diary.
Stool consistency
Measured using the Bristol stool form scale (7-day dairy; questionnaire)
Serum Vitamin E levels
Measured in blood sample. Analysis of serum vitamin E levels by Liquid chromatography-mass spectrometry.
Dietary intake
Measured using a 7-day food and drink diary
Acceptability of snack products
Measured using an Acceptability of dietary intervention questionnaire developed by King's College London for use in dietary intervention studies. The questionnaire assesses acceptability using a number of domains including flavour, texture and portion size.
Snack compliance
Measured via the return of unused snacks at the final visit (consumption of >75% of total snacks will be considered compliant).
Adverse events
Interview-administered questionnaire
Symptoms of depression and anxiety
Symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.
Change in symptoms of depression and anxiety
Change symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.
Proportion of people with no, mild, moderate and severe symptoms of anxiety and depression
Measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression and anxiety respectively.
Proportion of people with no, mild, moderate and severe symptoms of depression
Measured by the PHQ-8 questionnaire. Scores can range from 0 to 24, cut points of 5, 10, 15 and 20 indicate mild, moderate, moderately severe and severe levels of depression, respectively.
Proportion of people with no, mild, moderate and severe symptoms of anxiety
Measured by the GAD-7. The GAD-7 is comprised of 7 questions rated 0 to 3 indicating not at all, to nearly every day respectively and scores range from 0-21. Cut points are 5, 10 and 15 indicating mild, moderate and severe levels of anxiety, respectively.

Full Information

First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
King's College London
search

1. Study Identification

Unique Protocol Identification Number
NCT06087471
Brief Title
Snack Foods and Their Impact on Mental Health and the Gut-brain Axis
Acronym
NutriMood
Official Title
Snack Foods and Their Impact on the Gut-Brain Axis: a Randomised Controlled Trial on Mental Health and the Gut Microbiota
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 16, 2023 (Anticipated)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the effects of snack foods on mental health and the gut-brain axis, in adults with mild to moderate symptoms of depression and anxiety.
Detailed Description
There is increasing evidence on the potential modulating role of healthy dietary patterns in managing symptoms of psychological distress including but not limited to depression and anxiety. Despite growing evidence, further research is required to investigate how dietary interventions may impact symptoms of depression and anxiety, as well as their mechanisms of action via the gut-brain axis. Consumption of snacks now contributes to roughly 17% and 21% of daily energy intake for men and women respectively. Therefore, snacks greatly impact nutritional intake and diet quality and can be a target of dietary manipulation for potential health benefits. This will be the first randomised controlled trial to assess the impact of snack consumption on mental health in adults with mild to moderate symptoms of depression and anxiety. The trial will use a parallel design with a 12-week intervention. Stool and blood samples will be collected at the beginning and end of the intervention for measurement of the gut microbiota and biomarkers related to the gut-brain axis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Mental health, Gut-Brain Axis, Depression, Anxiety, Nutrition, Gut Microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control snack
Arm Type
Sham Comparator
Arm Description
42 participants will be randomly assigned to the control snack. Snacks should be consumed twice per day, once as a mid-morning snack and again as a mid-afternoon snack.
Arm Title
Experimental snack
Arm Type
Experimental
Arm Description
42 participants (50%) will be randomly assigned to snack on the intervention snack. Snacks should be consumed twice per day, once as a mid-morning snack and again as a mid-afternoon snack.
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention snack
Intervention Description
The intervention snack will be consumed by 42 participants for 12-weeks. Snacks will be consumed twice a day (mid-morning and mid afternoon snack).
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Snack
Intervention Description
The control snack will be consumed by 42 participants for 12-weeks. Snacks will be consumed twice a day (mid-morning and mid afternoon snack).
Primary Outcome Measure Information:
Title
Symptoms of depression and anxiety
Description
Symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.
Time Frame
Week 0 and 12
Secondary Outcome Measure Information:
Title
Functional impairment
Description
The self-report Work and social adjustment scale (WSAS) will be used to measure functional impairment scores. This is a self-report likert scale with 5 questions. Responses range from Not at all (0) to Very severely (8). 0-9, 10-19 and 20-40 represent low, moderate and severe impairment respectively.
Time Frame
Weeks 0,6 and 12
Title
Sleep quality
Description
The self-report Pittsburgh sleep quality index (PSQI) will be used to measure sleep quality. This is a 19-item questionnaire with seven subcategories; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Time Frame
Weeks 0,6 and 12
Title
Wellbeing
Description
The self-report world health organisation five well-being index (WHO-5) will be used to measure wellbeing. The scale consists of 5 items rated from All of the time (5) to At no time (0).
Time Frame
Weeks 0,6 and 12
Title
Quality of life
Description
The self-report World Health Organisation Quality of Life Brief (WHOQOL-BREF) scale will be used to measure quality of life. This is a 26-item scale. Responses are rated on a 1-5 likert scale with 1 representing 'not at all' and 5 representing 'completely agree'. Scores are tabulated and multiplied by 4 to represent a score out of 100.
Time Frame
Weeks 0,6 and 12
Title
Physical activity
Description
The self-report international Physical Activity Questionnaire - Short form (IPAQ) will be used to measure physical activity.
Time Frame
Weeks 0,6 and 12
Title
Symptoms of depression
Description
The self-report Patient Health Questionnaire-8 (PHQ-8) will be used to measure symptoms of depression. The PHQ-8 is comprised of 8 items rated 0 to 3 with 0 representing 'not at all' and 3 representing 'nearly every day'.
Time Frame
Weeks 0,6 and 12
Title
Symptoms of anxiety
Description
The self-report Generalised Anxiety disorder-7 scale will be used to measure symptoms of anxiety. The GAD-7 is comprised of 7 questions rated 0 to 3 indicating not at all, to nearly every day respectively.
Time Frame
Weeks 0,6 and 12
Title
Psychological Distress
Description
The Kessler Psychological Distress Scale (K10) will be used to measure symptoms of psychological distress. The K10 is comprised of 10 questions rated on a 5-point likert scale. Scores range from 10-50.
Time Frame
Weeks 0,6 and 12
Title
Faecal gut microbiota (composition, alpha- and beta-diversity)
Description
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples.
Time Frame
Week 0 and 12
Title
Faecal short-chain fatty acids (SCFA)
Description
Measured by gas liquid chromatography of stool samples
Time Frame
Week 0 and 12
Title
Faecal water
Description
Determined from stool samples by oven-drying
Time Frame
Week 0 and 12
Title
Gut symptoms
Description
Measured using the Gastrointestinal Symptom Rating Scale (GSRS) (7-day diary; questionnaire)
Time Frame
Week 0 and 12
Title
Stool frequency
Description
Measured using self-reported number bowel movements daily recorded in a 7-day diary.
Time Frame
Week 0 and 12
Title
Stool consistency
Description
Measured using the Bristol stool form scale (7-day dairy; questionnaire)
Time Frame
Week 0 and 12
Title
Serum Vitamin E levels
Description
Measured in blood sample. Analysis of serum vitamin E levels by Liquid chromatography-mass spectrometry.
Time Frame
Week 0 and 12
Title
Dietary intake
Description
Measured using a 7-day food and drink diary
Time Frame
Week 0 and 12
Title
Acceptability of snack products
Description
Measured using an Acceptability of dietary intervention questionnaire developed by King's College London for use in dietary intervention studies. The questionnaire assesses acceptability using a number of domains including flavour, texture and portion size.
Time Frame
Week 12
Title
Snack compliance
Description
Measured via the return of unused snacks at the final visit (consumption of >75% of total snacks will be considered compliant).
Time Frame
Week 12
Title
Adverse events
Description
Interview-administered questionnaire
Time Frame
Week 0 to 12
Title
Symptoms of depression and anxiety
Description
Symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.
Time Frame
Week 0,6 and 12
Title
Change in symptoms of depression and anxiety
Description
Change symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.
Time Frame
Week 0, 6 and 12
Title
Proportion of people with no, mild, moderate and severe symptoms of anxiety and depression
Description
Measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression and anxiety respectively.
Time Frame
Week 0, 6 and 12
Title
Proportion of people with no, mild, moderate and severe symptoms of depression
Description
Measured by the PHQ-8 questionnaire. Scores can range from 0 to 24, cut points of 5, 10, 15 and 20 indicate mild, moderate, moderately severe and severe levels of depression, respectively.
Time Frame
Week 0, 6 and 12
Title
Proportion of people with no, mild, moderate and severe symptoms of anxiety
Description
Measured by the GAD-7. The GAD-7 is comprised of 7 questions rated 0 to 3 indicating not at all, to nearly every day respectively and scores range from 0-21. Cut points are 5, 10 and 15 indicating mild, moderate and severe levels of anxiety, respectively.
Time Frame
Week 0, 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults aged 18-45 years old. Body mass index (BMI) between 18.50-29.99kg/m2 Score 10-29 on the patient health questionnaire anxiety and depression scale (PHQ-ADS) for mild to moderate symptoms of depression and anxiety. Individuals who regularly consume snacks (Classified as ≥2 per day excluding fruit, vegetable, nut and seed snacks). Willing to complete the 12-week intervention by adhering to snacks, complete mental health questionnaires, provide stool and blood samples, record weight and other anthropometric values and record food intake at various timepoints throughout the intervention. Willing to adhere to the protocol and provide informed consent. Fibre intake of <30g/d Willing to discontinue use of pre and probiotics during the trial. Exclusion Criteria: Dislike of intervention products. Allergy or intolerance to the intervention products Self-report occurrence of substance dependency or severe mental health conditions (e.g., psychosis, schizophrenia, eating disorder). Those with depressive disorders or anxiety disorders will be included in the trial providing they meet all other inclusion criteria. Regular consumption of experimental product as snacks and unwilling to complete a washout (no consumption for 4 weeks before baseline or during the study period). Changes to medication for depression or anxiety within the last 3 months (e.g., dosage, frequency, type) Initiation of any new medications for mental health or any form of talk therapy within the last 3 months. Intention to start or alter medication or therapy for mental health during the study. Current or previous antibiotic treatment within 4 weeks prior to the start of the study. Consumption of probiotics or prebiotic products within the 2 weeks prior to the start of the study Women who are pregnant, lactating or planning pregnancy Unexplained or unintentional weight loss in the past six months Medical history of any of the following: diabetes, major active or historic psychiatric conditions (e.g. schizophrenia), current eating disorder, alcohol abuse, active treatment for cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary disease (or any other chronic medical condition), severe oesophagitis, gastritis or duodenitis, active diverticulitis or intestinal/colonic strictures, Coeliac disease, Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection surgery (excluding appendicectomy and cholecystectomy), bleeding disorder, anaphylaxis or any other major or chronic condition known to impact study outcome measures.
Facility Information:
Facility Name
Metabolic research unit, Franklin-Wilkins Building, 150 stamford street
City
London
ZIP/Postal Code
SE19NH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Sartori, BSc
Phone
02078484552
Email
luke.sartori@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Eirini Dimidi, MSc, PhD
Phone
02078480485
Email
eirini.dimidi@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Snack Foods and Their Impact on Mental Health and the Gut-brain Axis

We'll reach out to this number within 24 hrs