Affect (Mental Function), Cognition, C Reactive Protein
Conditions
Keywords
prebiotics, fibre, cognition, depression, anxiety, inflammation
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTPrebiotic fibre fortified bread roll
Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day).
DIETARY_SUPPLEMENTRegular bread roll
Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day).
Sponsors
University of Reading
Innovate UK
Biotechnology and Biological Sciences Research Council
Myota Limited
Puratos Limited
Thriva Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment score | From baseline (pre intervention) to week 12 (post intervention) | Composite measure of global cognitive function - the total possible score is 30 points; a score of 26 or above is considered normal. |
| hs-CRP levels | From baseline (pre intervention) to week 12 (post intervention) | High- sensitivity C-Reactive protein (hs-CRP) levels in plasma samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Word Recall from the Rey Auditory Verbal Learning Task | From baseline (pre intervention) to week 12 (post intervention) | Participants will be presented with a sequential list of 15 words, at a rate of 1 word per second. The participant will then have 60s to say out loud as many of these words as possible, with the resulting score recorded as a percentage of accuracy. |
| Delayed Word Recall from the Rey Auditory Verbal Learning Task | From baseline (pre intervention) to week 12 (post intervention) | After a period of time subject are asked to recall as many words as possible from list A |
| Word Recognition from the Rey Auditory Verbal Learning Task | From baseline (pre intervention) to week 12 (post intervention) | Following the delayed word recall, words from list A, list B and novel words are displayed sequentially on the screen and participants are asked to indicate which words were from list A only. |
| EPIC Norfolk Food Frequency Questionnaire (FFQ) | From baseline (pre intervention) to week 12 (post intervention) | The FFQ is a validated tool for gauging the average habitual dietary intake of micro and macronutrients of an individual in the UK. Data will be processed using the FETA software. |
| Working Memory Questionnaire Score | From baseline (pre intervention) to week 12 (post intervention) | A measure assessing short-term storage, attention, and executive control |
| Gastrointestinal Symptom Rating Scale Scores | From baseline (pre intervention) to week 12 (post intervention) | A validated self-report measure of gastrointestinal symptoms that includes 15-items (combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation) . |
| Geriatric Depression Scale scores | From baseline (pre intervention) to week 12 (post intervention) | A validated self-report measure of depression that includes 15-items. |
| Geriatric Anxiety Inventory scores | From baseline (pre intervention) to week 12 (post intervention) | A validated self-report measure of anxiety that includes 20-items. |
| Positive and Negative Affect Schedule (PANAS) | From baseline (pre intervention) to week 12 (post intervention) | A 20-item questionnaire measuring positive and negative affect. |
| Lipid profiles | From baseline (pre intervention) to week 12 (post intervention) | Total-Cholesterol, Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C), and triglycerides will be assessed. |
| Hemoglobin A1c (HbA1c) | From baseline (pre intervention) to week 12 (post intervention) | Hemoglobin A1c (HbA1c) will be assessed. |
| Blood Pressure | From baseline (pre intervention) to week 12 (post intervention) | Systolic and diastolic blood pressure (in mmHg) will be measured. |
| Anthropometric outcomes | From baseline (pre intervention) to week 12 (post intervention) | Hip and waist circumference (in cm) will be measured. Additionally, weight (in kg) and height (in m) will be combined to report BMI in kg/m\^2. |
Countries
United Kingdom
Outcome results
None listed