BiomeBakery Project

University of Reading

Status: Active, not recruiting

Conditions: C Reactive Protein; Affect (Mental Function); Cognition

Treatments: Dietary Supplement: Regular bread roll; Dietary Supplement: Prebiotic fibre fortified bread roll

Study type: Interventional

Funder types: Other

Identifiers

NCT06796712

UREC 24/36

Details and patient eligibility

About

This study aims to investigate the chronic effects of prebiotic fibre-fortified functional bakery product on cognitive, affective, inflammatory, metabolic, and anthropometric outcomes in healthy adults aged 60-75 years with mild to moderate subjective cognitive complaints.

Full description

This study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of an 12 week prebiotic fibre-fortified functional bakery product on cognitive, affective, inflammatory, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints.

Seventy four participants will be randomised (1:1 ratio, matched by age, sex, and fibre intake) to Intervention or Placebo groups where they will be consuming a prebiotic fibre-fortified functional bakery product (containing 10g prebiotic fibre/day) or a regular bakery product (containing 0g prebiotic fibre/day), respectively, for 12-weeks. Outcome measures will be acquired before and after a 12-week chronic supplementation. These will include cognitive measures of overall cognitive functioning, immediate and delayed verbal memory, executive functions; affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; inflammatory measure of high sensitivity C-reactive protein (hs-CRP); metabolic measures of lipid profiles (total-C, LDL-C, HDL-C, triglycerides), Hemoglobin A1c (HbA1c) and systolic and diastolic blood pressure; and anthropometric measures of height, weight, hip and waist circumference.

Enrollment: 74 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aging between 60-75 years old
• Having normal vision and hearing
• Having a normal body mass index (BMI<30)
• Having mild to moderate subjective cognitive complaints
• Consuming bread (5 or more times a week)

Exclusion criteria

• Smoking
• Having food allergies
• Following restrictive and/or unbalanced diets
• Changing dietary intake majorly in past month
• Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders
• Being diagnosed with any cardiometabolic diseases (including type II diabetes and cardiovascular disease), or suffering from hypertension or thrombosis related disorders or suffer from thyroid disease
• Being anaemic
• Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
• Currently consuming prebiotic or probiotic supplements
• Continuous antibiotic use for > 3 days within 1 month prior to enrolment
• Continuous use of weight-loss drug for > 1 month before screening
• Having a significant gastrointestinal (GI) condition affecting absorption including (but not limited to) inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
• Having a high fibre intake defined as > 20g of fibre/day
• Wheat and/or gluten intolerance and having coeliac disease

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

Active: Prebiotic fibre-fortified bread roll

Experimental group

Description:

Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).

Treatment:

Dietary Supplement: Prebiotic fibre fortified bread roll

Placebo: Regular bread roll

Placebo Comparator group

Description:

Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).

Treatment:

Dietary Supplement: Regular bread roll