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

NCT ID: NCT06087471

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-05-21

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control snack

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.

Group Type: SHAM_COMPARATOR

Control Snack

Intervention Type: 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).

Experimental 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.

Group Type: EXPERIMENTAL

Intervention snack

Intervention Type: 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).

Interventions

Intervention snack

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

Control Snack

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).

Intervention Type: DIETARY_SUPPLEMENT

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.

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

1423790

Identifier Type: -

Identifier Source: org_study_id