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Manipulation of the gut microbiota through dietary modification affects brain function, with improvement in patients with cognitive disorders. Combined effect of nutritional intervention with Mediterranean diet and probiotics with potentially healthy growth of germ, affect the evolution of mild cognitive impairment, by the modulation of components related with the axis microbiota-gut-brain: neuropeptides, short-chain fatty acids, markers for oxidative stress and inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy diet Arm | Placebo Comparator | Healthy diet (WHO recommendations) + placebo |
|
| Mediterranean diet Arm | Placebo Comparator | Mediterranean diet + placebo |
|
| Mediterranean diet "plus" Arm | Active Comparator | Mediterranean diet + Biopolis-MIX42 (1 capsule per day containing 10^9 colony forming units of Lactobacillus rhamnosus and Bifidobacterium long). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet | Dietary Supplement | Mediterranean diet: 22% Monounsaturated fat, 6% Polyunsaturated fat, 7% Saturated fat, 15% Protein, 50% Carbohydrates |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive change | Cognitive change in Alzheimer's Disease Assessment Scale-Cognitive-Plus ("ADAS-Cog- Plus"). The total ADAS-Cog-plus score ranges from 0-70 with higher scores suggesting greater impairment. | Baseline and 24 weeks after each dietary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota pattern | Changes in the percentage of different families of Microbiota will be analysed during the study | Baseline and 24 weeks after each dietary intervention |
| Endotoxemia levels | Changes in the endotoxemia levels will be analysed during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Perez-Martinez, PhD, MD | IMIBIC/ Reina Sofia University Hospital / University of Cordoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reina Sofia University Hospital | Córdoba | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36570150 | Derived | Cardelo MP, Corina A, Leon-Acuna A, Quintana-Navarro GM, Alcala-Diaz JF, Rangel-Zuniga OA, Camargo A, Conde-Gavilan C, Carmona-Medialdea C, Vallejo-Casas JA, Carmona-Asenjo E, Ochoa-Sepulveda JJ, Aguera-Morales E, Delgado-Lista J, Katsiki N, Lopez-Miranda J, Perez-Jimenez F, Yubero-Serrano EM, Perez-Martinez P. Effect of the Mediterranean diet and probiotic supplementation in the management of mild cognitive impairment: Rationale, methods, and baseline characteristics. Front Nutr. 2022 Dec 8;9:1037842. doi: 10.3389/fnut.2022.1037842. eCollection 2022. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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50 men and women with mild cognitive impairment and more than 60 years will follow three dietary intervention periods of 24 weeks each, with a randomized crossover design. Dietary periods will be: 1.- Healthy diet (WHO recommendations) + placebo; 2.- Mediterranean diet + placebo and ; 3.- Mediterranean diet "plus" (Mediterranean diet + Biopolis-MIX42 (a capsule containing 10^9 colony forming units of Lactobacillus rhamnosus and Bifidobacterium longum)).
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| Healthy diet (WHO recommendations) | Dietary Supplement | Recommendations according to WHO |
|
| Placebo | Dietary Supplement | Placebo |
|
| Biopolis-MIX42 | Dietary Supplement | Biopolis-MIX42: a capsule containing 10^9 colony forming units of Lactobacillus rhamnosus and Bifidobacterium longum. |
|
| Baseline and 24 weeks after each dietary intervention |
| Change in inflammatory marker | At time 0 and after 24 weeks of each intervention period and follow-up, the levels of high sesitivity C-reactive protein (hs-CRP) were determined in plasma in mg/dL. | Baseline and 24 weeks after each dietary intervention |
| Change in oxidative stress parameters | At time 0 and after 24 weeks of each intervention period and follow-up, the levels of advanced glycation end products (AGEs) were determined in serum in ug/mL: methylglioxal (MG) and N-carboxymethyllysine (CML). Likewise, carbonilated proteins in nmol/mg and lipid peroxidation levels in plasma in ug/mL. | Baseline and 24 weeks after each dietary intervention |
| Neurofunctional change | At time 0 and after 24 weeks of each intervention period and follow-up, neurofunctional changes were measured by emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose (18F-FDG-PET) | Baseline and 24 weeks after each dietary intervention |
| Modulation of Microbiota-gut-nervous system | Changes in the plasma levels of molecules with activity on the nervous system were analysed during the study. At time 0 and after 24 weeks of each intervention period and follow-up, Gamma-Aminobutiric acid (GABA) in ng/mL and short-chain fatty acids (acetate, propionate and butirate) in ng/mL were determined in plasma. | Baseline and 24 weeks after each dietary intervention |
| Change in cytokine levels | At time 0 and after 24 weeks of each intervention period and follow-up, the levels of interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-a) were determined in plasma in pg/mL. | Baseline and 24 weeks after each dietary intervention |
| Neuropeptides modulation | Changes in the plasma levels of molecules with activity on the nervous system were analysed during the study. At time 0 and after 24 weeks of each intervention period and follow-up, Substance P (SP), Y Peptide (PYY), beta-amyloid in pg/mL were determined in plasma. | Baseline and 24 weeks after each dietary intervention |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |