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

NCT06087471 | Completed

• 1 other identifier: 1423790
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

Mental health; Gut-Brain Axis; Depression; Anxiety; Nutrition; Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 0 and 12

Secondary Outcomes (24)

• Functional impairment

  Weeks 0,6 and 12

• Sleep quality

  Weeks 0,6 and 12

• Wellbeing

  Weeks 0,6 and 12

• Quality of life

  Weeks 0,6 and 12

• Physical activity

  Weeks 0,6 and 12

Study Arms (2)

Control snack

SHAM COMPARATOR

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.

Dietary Supplement: Control Snack

Experimental snack

EXPERIMENTAL

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.

Dietary Supplement: Intervention snack

Interventions

Intervention snack DIETARY_SUPPLEMENT

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).

Experimental snack

Control Snack DIETARY_SUPPLEMENT

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).

Control snack

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Dislike of intervention products.
• Allergy or intolerance to the intervention products
• 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.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

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

London, SE19NH, United Kingdom

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: October 16, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: February 18, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)