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| Name | Class |
|---|---|
| Innovate UK | OTHER_GOV |
| Biotechnology and Biological Sciences Research Council | OTHER |
| Myota Limited | UNKNOWN |
| Puratos Limited |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active: Prebiotic fibre-fortified bread roll | Experimental | Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day). |
|
| Placebo: Regular bread roll | Placebo Comparator | Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic fibre fortified bread roll | Dietary Supplement | Subjects will consume a prebiotic fibre-fortified bread roll (10g of added prebiotic fibre/day). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment score | Composite measure of global cognitive function - the total possible score is 30 points; a score of 26 or above is considered normal. | From baseline (pre intervention) to week 12 (post intervention) |
| hs-CRP levels | High- sensitivity C-Reactive protein (hs-CRP) levels in plasma samples | From baseline (pre intervention) to week 12 (post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Word Recall from the Rey Auditory Verbal Learning Task | 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. | From baseline (pre intervention) to week 12 (post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| FiberScreen Scores | A questionnaire that assesses fibre intake. It will be used to screen participants. Individuals who adhere to a high fibre diet (>20g fibre/day) will be excluded from the study. | Baseline (pre intervention) |
| Telephone Interview for Cognitive Status-40 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Reading, School of Psychology and Clinical Languages | Reading | Berkshire | RG6 6BZ | United Kingdom |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
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| UNKNOWN |
| Thriva Limited | UNKNOWN |
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| Regular bread roll | Dietary Supplement | Subjects will consume a regular bread roll (0g of added prebiotic fibre blend/day). |
|
| Delayed Word Recall from the Rey Auditory Verbal Learning Task | After a period of time subject are asked to recall as many words as possible from list A | From baseline (pre intervention) to week 12 (post intervention) |
| Word Recognition from the Rey Auditory Verbal Learning Task | 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. | From baseline (pre intervention) to week 12 (post intervention) |
| EPIC Norfolk Food Frequency Questionnaire (FFQ) | 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. | From baseline (pre intervention) to week 12 (post intervention) |
| Working Memory Questionnaire Score | A measure assessing short-term storage, attention, and executive control | From baseline (pre intervention) to week 12 (post intervention) |
| Gastrointestinal Symptom Rating Scale Scores | 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) . | From baseline (pre intervention) to week 12 (post intervention) |
| Geriatric Depression Scale scores | A validated self-report measure of depression that includes 15-items. | From baseline (pre intervention) to week 12 (post intervention) |
| Geriatric Anxiety Inventory scores | A validated self-report measure of anxiety that includes 20-items. | From baseline (pre intervention) to week 12 (post intervention) |
| Positive and Negative Affect Schedule (PANAS) | A 20-item questionnaire measuring positive and negative affect. | From baseline (pre intervention) to week 12 (post intervention) |
| Lipid profiles | Total-Cholesterol, Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C), and triglycerides will be assessed. | From baseline (pre intervention) to week 12 (post intervention) |
| Hemoglobin A1c (HbA1c) | Hemoglobin A1c (HbA1c) will be assessed. | From baseline (pre intervention) to week 12 (post intervention) |
| Blood Pressure | Systolic and diastolic blood pressure (in mmHg) will be measured. | From baseline (pre intervention) to week 12 (post intervention) |
| Anthropometric outcomes | 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. | From baseline (pre intervention) to week 12 (post intervention) |
A questionnaire that assesses cognitive status. It will be used to screen participants. Only individuals who score between 6 and 20 (depicting mild to moderate subjective cognitive complaints) will be included in the study. |
| Baseline (pre intervention) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |