PROMOTE: The Effect of a Six Week Prebiotic Supplementation on Wellbeing of Young Adults.

University of Southampton

Status: Not yet enrolling

Conditions: Healthy; Wellbeing; Mental Health

Treatments: Dietary Supplement: Prebiotic; Dietary Supplement: Maltodextrin (Corn)

Study type: Interventional

Funder types: Other

Identifiers

NCT06566157

340693

89554 (Other Identifier)

Details and patient eligibility

About

The study will investigate whether taking a prebiotic for six weeks helps to reduce morning cortisol levels in healthy young adults with mild to moderate stress compared to a placebo. Individuals should continue with their usual lifestyle during the study. Other factors of wellbeing will also be assessed.

Full description

PROMOTE is a double blinded parallel randomised controlled-trial investigating if prebiotic supplementation reduce awakening salivary cortisol response, reported as area under the curve compared to a maltodextrin placebo in healthy young adults with a mild-to-moderate self reported stress score. There will be a focus on biological secondary outcomes to better understand how supplementation may influence the microbiome using metabolomics and sequencing techniques. In addition to other measures of wellbeing captured by questionnaires and activity monitors.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 18-25 at time of recruitment
• Body Mass Index (18.5 - 29.9 kg) : Healthy - Overweight
• Stress score of 15≤ - ≥25 (DASS)
• Willing and with capacity to give informed consent to participate at time of recruitment
• Speak and comprehend English to a good standard
• In good general health
• Willing to provide stool, urine and blood (8mL) sample during intervention
• Willing to attend 4 visits to Southampton General Hospital Clinical Research Facility over 10-11 weeks

Exclusion criteria

• Consuming ≥ 14 units of alcohol/week (6 x 175 mL of wine, 6 pints of 4% beer)
• Learning or behavioural difficulties (assessed on individual basis)
• Planning a pregnancy in the next 6 months, pregnant, lactating or had a recent birth ≥6 months
• Currently smoking or using e-cigarette, vape
• Vulnerable adults (with self reported sever or very severe stress score (DASS)
• Unwilling to suspend existing probiotic / prebiotic supplementation (with additional 4 weeks washout) before starting study.

Medical exclusions:

• Actively involved in therapy or psychiatric intervention of a diagnosed mental health condition
• Prescribed psychotropic medication (Antidepressants, Monoamine Oxidase Inhibitors (MAOI's), Antipsychotics, sleeping pills, mood stabilisers etc)
• Allergic to milk, soy, corn, penicillin or fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPS)
• Currently prescribed laxatives, enemas, anti-coagulants or painkillers
• Existing medical condition: cancer, hepatobiliary surgery, diabetes or diagnosed gastrointestinal diseases (irritable bowel disease, ulcerative colitis)
• Involved in a recent pharmacology/psychological intervention, last 6 months
• Recent antibiotic prescription, last 6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Prebiotic

Experimental group

Description:

WellBiome® prebiotic complex Inulin 67%, Xylooligosaccharides (XOS) 27%, Magnesium Chloride (MgCl2) 9.8 %

Treatment:

Dietary Supplement: Prebiotic

Maltodextrin

Placebo Comparator group

Description:

Maltodextrin (Corn origin)

Treatment:

Dietary Supplement: Maltodextrin (Corn)