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| Name | Class |
|---|---|
| Biotechnology and Biological Sciences Research Council | OTHER |
| Myota Limited | UNKNOWN |
| i-NutriLife Hub | UNKNOWN |
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This pilot study aims to investigate the chronic effects of a prebiotic blend on cognitive, affective and gut microbiome outcomes in healthy adults aged 60-75 years.
This pilot study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 12-week-long prebiotic blend consumption on cognitive, affective, gut microbiome, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Fifty participants will be randomised to Intervention or Placebo groups where they will be consuming 10g of prebiotic fibre blend or 10g of placebo (matched placebo powder) per day 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, and domain-specific cognitive performance, affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. In addition, stool samples will be collected at all timepoints to assess microbiome diversity and composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active: prebiotic blend (powder) | Experimental | Subjects will consume 10g of prebiotic fibre powder in their tea/coffee/water at breakfast. |
|
| Active: matched placebo (powder) | Placebo Comparator | Subjects will consume 10g of matched placebo powder in their tea/coffee/water at breakfast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic blend | Dietary Supplement | 10g of prebiotic fibre blend powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Drug Research Computerized Assessment System (COGDRAS) scores | The COGDRAS battery consists of 8 individual cognitive tests testing memory, attention and reaction times. | From baseline (pre intervention) to week 12 (post intervention) |
| Gut microbiome diversity | Stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing). | From baseline (pre intervention) to week 12 (post intervention) |
| Gut microbiome composition | Stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing). | From baseline (pre intervention) to week 12 (post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Telephone Interview for Cognitive Status-40 | 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) |
| FiberScreen Scores |
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 6ES | United Kingdom |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Placebo | Dietary Supplement | 10g of matched placebo powder |
|
A validated self-report measure of anxiety that includes 20-items.
| From baseline (pre intervention) to week 12 (post intervention) |
| Montreal Cognitive Assessment (MoCA) score | Composite measure of global cognitive function | 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) |
| Blood Pressure | Systolic and diastolic blood pressure (in mmHg) will be measured. | 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) |
| Hip and waist circumference | Hip and waist circumference (in cm) will be measured. | From baseline (pre intervention) to week 12 (post intervention) |
| Body Mass Index | 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 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) |
| 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. | Baseline (pre intervention) |