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| Name | Class |
|---|---|
| ABC Nutritionals | UNKNOWN |
| Sensus B.V. (Royal Cosun), Roosendaal, The Netherlands | UNKNOWN |
| University of Leeds | OTHER |
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Ageing is associated with changes in gut microbiota composition, increased inflammation, and a greater risk of poor mental health outcomes. Nutritional inadequacies, including low dietary fibre intake and suboptimal B-vitamin status, are common in older adults and may contribute to these age-related health issues. Research suggests that increasing dietary fibre intake, particularly through prebiotics such as inulin, may help to improve gut health. In addition, B-vitamins have been linked to both gut and mental health, although their combined effects with prebiotics are not well understood.
With the assistance of a food company, the investigators have developed a functional drink enriched with chicory inulin, alone or in combination with B-vitamins. Therefore, the investigators plan to conduct a 12-week randomised, double-blind, placebo-controlled trial to test the effect of this functional drink on gut health outcomes, nutritional status, inflammation, and mental health in adults aged 50 years and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inulin and B-vitamins | Active Comparator |
| |
| Inulin only | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inulin and B-vitamins | Dietary Supplement | A functional beverage containing inulin (7.5 g per serving) combined with B-vitamins folic acid (100μg), vitamin B12 (5μg), vitamin B6 (5mg) and riboflavin (2.5mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome profile | Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline. | 12 weeks |
| Serum total homocysteine | Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation. | 12 weeks |
| Folate | Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei. | 12 weeks |
| Vitamin B12 | Serum total vitamin B12 measured by microbiological assay based on a colistin sulphate-resistant strain of Lactobacillus leichmannii; serum methylmalonic acid measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation. | 12 weeks |
| Vitamin B6 | Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection. | 12 weeks |
| Riboflavin | Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation | Markers of inflammation (analysed by enzyme-linked immunosorbent assay): C-reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), tumour necrosis factor (TNF-α). | 12 weeks |
| Gut microbial metabolites |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shane Gordon, PhD | Contact | +44 28 7012 3035 | S.Gordon2@ulster.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Intervention Studies Unit | Recruiting | Coleraine | County Londonderry | BT521SA | United Kingdom |
All IPD that underlie results in a publication
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Twice daily intervention for 12 weeks with one of the following treatments (in powder form):
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| Inulin | Dietary Supplement | A functional drink containing inulin (7.5 g per serving) without additional B-vitamins. |
|
| Placebo | Dietary Supplement | A control/placebo drink with similar energy content (~182 kJ / 43 kcal/ per serving) but without the additional nutrient provision. |
|
Faecal short-chain fatty acids (SCFAs)
| 12 weeks |
| Depressive symptoms | Measured using the Centre for Epidemiological Studies Depression Scale (CES-D). | 12 weeks |
| Anxiety symptoms | Measured using the Hospital Anxiety and Depression Scale (HADS). | 12 weeks |
| Sleep quality | Measured using the Pittsburgh Sleep Quality Index (PSQI). | 12 weeks |
| Physiological stress | Serum cortisol concentrations measured as a biomarker of physiological stress. | 12 weeks |
| ID | Term |
|---|---|
| D007444 | Inulin |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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