Non-Alcoholic Fatty Liver Disease, Obese, Overweight
Conditions
Keywords
NAFLD, NASH, Obesity, AASLD, AHA, Energy-restricted diet, Lifestyle intervention, Mediterranean diet, Weight loss, Liver damage, Inflammation, Oxidative stress, Microbiota composition, Eating behaviour, Satiety, Physical activity, Sedentary behaviours, Sleep quality, Sleep duration, Psychological factors, Nutrigenomics, Nutrigenetics, Transcriptomics, Epigenetics, Metabolomics, miRNAs, Lipidomics
Brief summary
Non-alcoholic fatty liver disease (NAFLD) is a condition of excessive hepatic lipid accumulation in subjects that consume less than 20g ethanol per day, without other known causes as drugs consumption or toxins exposure. In Western countries, the rate of this disease lies about 30% in the general adult population. The process of developing NAFLD can start from simple steatosis to non-alcoholic steatohepatitis (NASH), which eventually can lead to cirrhosis and hepatocellular carcinoma in the absence of alcohol abuse. Liver biopsy is considered the gold standard of steatosis, fibrosis and cirrhosis. However, it is rarely performed because it is an invasive procedure and investigators are focusing in the application of non-invasive liver damage scores for diagnosis. The pathogenesis of NAFLD is multifactorial and triggered by environmental factors such as unbalanced diets and overnutrition as well as by lack of physical activity in the context of a genetic predisposition. Nowadays, the treatment of NAFLD is based on diet and lifestyle modifications. Weight loss, exercise and healthy eating habits are the main tools to fight NAFLD. Nevertheless, there is no a well characterized dietary pattern and further studies are necessary. With this background, the general aim of this project is to increase the knowledge on the influence of nutritional/lifestyle interventions in obese patients with NAFLD, as well as contribute to identify non-invasive biomarkers/scores to early diagnosis of this pathology in future obese people.
Detailed description
This project is framed within the promotion of health and lifestyles and, specifically, in liver disorder linked to obesity (FLiO: Fatty Liver in Obesity). The investigation addresses a randomized, parallel, long-term personalized nutritional intervention with two strategies: 1) Control diet based on American Heart Association (AHA); 2) Fatty Liver in Obesity (FLiO) diet based on previous results (RESMENA project).The diet is based on macronutrient distribution, quality and quantity, and is characterized by a low glycemic load, high adherence to the Mediterranean diet and a high antioxidant capacity, with the inclusion of anti-inflammatory foods. It also takes into account the distribution of food throughout the day, number of meals, portion sizes, timing of meal, individual needs, dietary behavior (behavioral therapy: eat slowly, teach what to buy, what to eat, when to eat). The participants are instructed to follow this strategy. This strategy (RESMENA) was even more effective than AHA after 6 months follow-up, in terms of significant reduction of abdominal fat and blood glucose level. In addition, this diet had beneficial effects for participants who were obese and had values of altered glucose, reducing significantly in RESMENA participants LDL-oxidized marker. These results are very important to apply in the present investigation since that patients with NAFLD are commonly insulin resistant. Both strategies were designed within a hypocaloric dietary pattern (-30%) in order to achieve the American Association for the Study of Liver Diseases (AASLD) recommendations for the management of non-alcoholic liver disease (loss of at least 3-5% of body weight appears necessary to improve steatosis, but a greater weight loss, up to 10%, may be needed to improve necroinflammation). At this time the participants are individually supervised and encouraged to follow with the dietary planning instructions assigned. Furthermore, at baseline, 6, 12 and 24 months anticipated variables are obtained. Both dietary groups receive routine control (weight, body composition, strategy adherence) and dietary advice daily by phone (if they need help) and face to face at the time of routine control. In order to get a integral lifestyle intervention, all participants will be encouraged to follow a healthy lifestyle. Thus, physical activity will be recorded in each dietary group. The specific tasks: 1. To recruit and select patients with the adequate characteristics to validate the conclusions reached. 2. To develop and adequately transmit to each patient a personalized strategy according to the group randomly assigned ( AASLD vs FLiO strategy). 3. To check the degree of adherence to the strategy set by regular monitoring: semiquantitative questionnaires of food consumption frequency, pedometers, accelerometers, weight control, satiety. 4. To assess the effect of each strategy on body composition (weight, waist circumference, body fat, muscle mass, bone mineral density), physical status, general biochemistry (lipid profile, glycaemic profile, albumin, blood count, transaminases), specific biomarkers/metabolites in blood or urine (inflammation, oxidative stress, liver damage, appetite, psychological status), quality of life and related factors (anxiety, depression and sleep). 5. To check the evolution of the liver damage, using non-invasive techniques (ultrasound, elastography and magnetic resonance imaging (MRI), metabolomics analysis) and calculating different validated liver scores from the data obtained with each strategy. 6. To compare the effectiveness of strategies, considering not only the ability to decrease body fat, but also other risk factors present in the NAFLD patient such as insulin resistance and cardiovascular risk, which will result in improvement of liver damage. 7. To analyze SNPs (DNA from oral epithelial cells) and the association with NAFLD (diagnosis and response to the strategies). 8. To study gene expression (mRNAs) and microRNAs in white blood cells for identifying biomarkers of diagnosis and response to dietary strategy. 9. To analyze gene DNA methylation patterns in white blood cells for identifying biomarkers of diagnosis and response to dietary strategy. 10. To describe the intestinal microbiota composition by 16s sequencing at baseline and after nutritional intervention for diagnosis and response.
Interventions
OTHERControl diet
The participants follow a conventional and balanced distribution of macronutrients (30% fat, 15% protein, 55% carbohydrates), adequate fiber (25-30 g/day) and dietary cholesterol (\<250 mg/day) intake according to AHA guidelines. This strategy was included within a personalized energy-restricted diet (-30% individual needs) under healthy lifestyle advice in order to achieve the objectives of AASLD (loss of at least 3-5% of the initial body weight and up to 10% needed to improve necroinflammation).
OTHERFLiO diet
The participants follow a strategy based on a distribution of macronutrients 30-35% lipid (extra virgin olive oil and fatty acids Ω3 in detriment of saturated, trans and cholesterol)/ protein 25% (vegetable against animal)/carbohydrates 40-45% (low glycaemic index, fiber 30-35 g/day); high adherence to the Mediterranean diet and natural antioxidants; meal frequency of 7 meals/day; size/composition of the ration suitable for each moment; including traditional foods with no additional economic cost that will allow diet adherence without abandonment; avoid inappropriate mealtimes and the eating manners as the eating rate. The participants are instructed to follow this strategy within a personalized energy-restricted diet (-30%) and under healthy lifestyle advice to achieve AASLD objectives.
Sponsors
Complejo Hospitalario de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
The participants are randomly assigned to Control or FLiO strategy.
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Overweight or obese * Diagnosis of NAFLD * Age: 30-80 years * Female / Male
Exclusion criteria
* Known liver disease (other than NAFLD) * Abuse of alcohol (\>21 and \>14 units of alcohol a week for men and women, respectively, eg 1 unit = 125 mL of wine); * Drug treatments: immunosuppressants, cytotoxic agents, systemic corticosteroids, agents potentially causing fatty liver disease or abnormal liver tests or weight modifiers * Active cancer or a history of malignancy in the last 5 years * Problems of massive edemas * Obesity known endocrine origin (except treated hypothyroidism) * Surgical procedure for weight loss * ≥ 3kg weight loss in the last 3 months * Severe psychiatric disorders * Lack of autonomy or inability to follow the diet (including food allergies or intolerances) or/and lifestyle recommendations as well as to follow scheduled visits. * Consumption of any type of food supplements (antioxidants, prebiotics, probiotics, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from 6 month Weight at 12 months | 6 months and 12 months | Weight will be measured by a digital scale |
| Change from Baseline Weight at 12 months | Baseline and 12 months | Weight will be measured by a digital scale |
| Change from Baseline Weight at 6 months | Baseline and 6 months | Weight will be measured by a digital scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from 6 month Hemoglobin A1c concentration at 12 months | 6 months and 12 months | Serum Hemoglobin A1c will be measured in a fasting state |
| Change from Baseline Body fat at 6 months | Baseline and 6 months | Fat mass will be measured by Dual X-ray absorptiometry |
| Change from 6 month Body fat at 12 months | 6 months and 12 months | Fat mass will be measured by Dual X-ray absorptiometry |
| Change from Baseline Body fat at 12 months | Baseline and 12 months | Fat mass will be measured by Dual X-ray absorptiometry |
| Change from Baseline Waist circumference at 6 months | Baseline and 6 months | Waist circumference will be measured with a tape measure |
| Change from 6 month Waist circumference at 12 months | 6 months and 12 months | Waist circumference will be measured with a tape measure |
| Change from Baseline Waist circumference at 12 months | Baseline and 12 months | Waist circumference will be measured with a tape measure |
| Change from Baseline handgrip strength at 6 months | Baseline and 6 months | Handgrip strength will be measured with a dynamometer |
| Change from 6 month handgrip strength at 12 months | 6 months and 12 months | Handgrip strength will be measured with a dynamometer |
| Change from Baseline handgrip strength at 12 months | Baseline and 12 months | Handgrip strength will be measured with a dynamometer |
| Change from Baseline Systolic blood pressure at 6 months | Baseline and 6 months | Systolic blood pressure will be measured with a sphygmomanometer |
| Change from 6 month Systolic blood pressure at 12 months | 6 months and 12 months | Systolic blood pressure will be measured with a sphygmomanometer |
| Change from Baseline Systolic blood pressure at 12 months | Baseline and 12 months | Systolic blood pressure will be measured with a sphygmomanometer |
| Change from Baseline Diastolic blood pressure at 6 months | Baseline and 6 months | Diastolic blood pressure will be measured with a sphygmomanometer |
| Change from 6 month Diastolic blood pressure at 12 months | 6 months and 12 months | Diastolic blood pressure will be measured with a sphygmomanometer |
| Change from Baseline Diastolic blood pressure at 12 months | Baseline and 12 months | Diastolic blood pressure will be measured with a sphygmomanometer |
| Change from Baseline lipid metabolism at 6 months | Baseline and 6 months | Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state |
| Change from 6 month lipid metabolism at 12 months | 6 months and 12 months | Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state |
| Change from Baseline Hemoglobin A1c concentration at 12 months | Baseline and 12 months | Serum Hemoglobin A1c will be measured in a fasting state |
| Change from Baseline lipid metabolism at 12 months | Baseline and 12 months | Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state |
| Change from Baseline uric acid concentration at 6 months | Baseline and 6 months | Serum uric acid will be measured in a fasting state |
| Change from 6 month uric acid concentration at 12 months | 6 months and 12 months | Serum uric acid will be measured in a fasting state |
| Change from Baseline uric acid concentration at 12 months | Baseline and 12 months | Serum uric acid will be measured in a fasting state |
| Change from Baseline homocysteine concentration at 6 months | Baseline and 6 months | Serum homocysteine will be measured in a fasting state |
| Change from 6 month homocysteine concentration at 12 months | 6 months and 12 months | Serum homocysteine will be measured in a fasting state |
| Change from Baseline homocysteine concentration at 12 months | Baseline and 12 months | Serum homocysteine will be measured in a fasting state |
| Change from Baseline glucose metabolism at 6 months | Baseline and 6 months | Serum glucose levels will be measured in a fasting state |
| Change from 6 month glucose metabolism at 12 months | 6 months and 12 months | Serum glucose levels will be measured in a fasting state |
| Change from Baseline glucose metabolism at 12 months | Baseline and 12 months | Serum glucose levels will be measured in a fasting state |
| Change from Baseline insulin concentration at 6 months | Baseline and 6 months | Serum insulin levels will be measured in a fasting state |
| Change from 6 month insulin concentration at 12 months | 6 months and 12 months | Serum insulin levels will be measured in a fasting state |
| Change from Baseline insulin concentration at 12 months | Baseline and 12 months | Serum insulin levels will be measured in a fasting state |
| Change from Baseline Hemoglobin A1c concentration at 6 months | Baseline and 6 months | Serum Hemoglobin A1c will be measured in a fasting state |
| Change from Baseline liver function at 6 months | Baseline and 12 months | Serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, alkaline phosphatase, creatinine, total protein, albumin, prothrombin will be measured in a fasting state |
| Change from 6 month liver function at 12 months | 6 months and 12 months | Serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, alkaline phosphatase, creatinine, total protein, albumin, prothrombin will be measured in a fasting state |
| Change from Baseline liver function at 12 months | Baseline and 12 months | Serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, alkaline phosphatase, creatinine, total protein, albumin, prothrombin will be measured in a fasting state |
| Change from Baseline fibroblast growth factor 21 (FGF21) concentration at 6 months | Baseline and 6 months | Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state |
| Change from 6 month fibroblast growth factor 21 (FGF21) concentration at 12 months | 6 months and 12 months | Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state |
| Change from Baseline fibroblast growth factor 21 (FGF21) concentration at 12 months | Baseline and 12 months | Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state |
| Change from Baseline cytokeratin-18 (CK18) concentration at 6 months | Baseline and 6 months | Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state |
| Change from 6 month cytokeratin-18 (CK18) concentration at 12 months | 6 months and 12 months | Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state |
| Change from Baseline cytokeratin-18 (CK18) concentration at 12 months | Baseline and 12 months | Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state |
| Change from Baseline C-reactive protein (CRP) concentration at 6 months | Baseline and 6 months | Plasma CRP will be assessed to determine inflammatory status |
| Change from 6 month C-reactive protein (CRP) concentration at 12 months | 6 months and 12 months | Plasma CRP will be assessed to determine inflammatory status |
| Change from Baseline C-reactive protein (CRP) concentration at 12 months | Baseline and 12 months | Plasma CRP will be assessed to determine inflammatory status |
| Change from Baseline interleukin 6 (IL-6) concentration at 6 months | Baseline and 6 months | Plasma IL-6 will be assessed to determine inflammatory status |
| Change from 6 month interleukin 6 (IL-6) concentration at 12 months | 6 months and 12 months | Plasma IL-6 will be assessed to determine inflammatory status |
| Change from Baseline interleukin 6 (IL-6) concentration at 12 months | Baseline and 12 months | Plasma IL-6 will be assessed to determine inflammatory status |
| Change from Baseline tumor necrosis factor-α (TNFα) concentration at 6 months | Baseline and 6 months | Plasma TNF-alpha will be assessed to determine inflammatory status |
| Change from 6 month tumor necrosis factor-α (TNFα) concentration at 12 months | 6 months and 12 months | Plasma TNF-alpha will be assessed to determine inflammatory status |
| Change from Baseline leptin concentration at 12 months | Baseline and 12 months | Plasma leptin will be assessed to determine inflammatory status |
| Change from Baseline adiponectin concentration at 6 months | Baseline and 6 months | Plasma leptin will be assessed to determine inflammatory status |
| Change from 6 month adiponectin concentration at 12 months | Baseline and 12 months | Plasma adiponectin will be assessed to determine inflammatory status |
| Change from Baseline adiponectin concentration at 12 months | Baseline and 12 months | Plasma adiponectin will be assessed to determine inflammatory status |
| Change from Baseline LDL-oxidized concentration at 6 months | Baseline and 6 months | LDL-ox will be assessed to determine oxidative status |
| Change from 6 month LDL-oxidized concentration at 12 months | 6 months and 12 months | LDL-ox will be assessed to determine oxidative status |
| Change from Baseline LDL-oxidized concentration at 12 months | Baseline and 12 months | LDL-ox will be assessed to determine oxidative status |
| Change from Baseline Malondialdehyde concentration at 6 months | Baseline and 6 months | Plasma malondialdehyde will be assessed to determine oxidative status |
| Change from 6 month Malondialdehyde concentration at 12 months | 6 months and 12 months | Plasma malondialdehyde will be assessed to determine oxidative status |
| Change from Baseline Malondialdehyde concentration at 12 months | Baseline and 12 months | Plasma malondialdehyde will be assessed to determine oxidative status |
| Change from Baseline plasma antioxidant capacity at 6 months | Baseline and 6 months | Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP) |
| Change from 6 month plasma antioxidant capacity at 12 months | 6 months and 12 months | Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP) |
| Change from Baseline plasma antioxidant capacity at 12 months | Baseline and 12 months | Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP) |
| Change from Baseline Hepatic echography at 6 months | Baseline and 6 months | Echography will be carried out to analyze liver steatosis |
| Change from 6 month Hepatic echography at 12 months | 6 months and 12 months | Echography will be carried out to analyze liver steatosis |
| Change from Baseline Hepatic echography at 12 months | Baseline and 12 months | Echography will be carried out to analyze liver steatosis |
| Change from Baseline Hepatic elastography at 6 months | Baseline and 6 months | Elastography will be carried out to analyze liver fibrosis |
| Change from 6 month Hepatic elastography at 12 months | 6 months and 12 months | Elastography will be carried out to analyze liver fibrosis |
| Change from Baseline Hepatic elastography at 12 months | Baseline and 12 months | Elastography will be carried out to analyze liver fibrosis |
| Change from Baseline Hepatic Magnetic Resonance Imaging at 6 months | Baseline and 6 months | Magnetic Resonance Imaging will be carried out to analyze liver status |
| Change from 6 month Hepatic Magnetic Resonance Imaging at 12 months | 6 months and 12 months | Magnetic Resonance Imaging will be carried out to analyze liver status |
| Change from Baseline Hepatic Magnetic Resonance Imaging at 12 months | Baseline and 12 months | Magnetic Resonance Imaging will be carried out to analyze liver status |
| Change from Baseline White blood cell count at 6 months | Baseline and 6 months | White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils. |
| Change from 6 month White blood cell count at 12 months | 6 months and 12 months | White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils. |
| Change from Baseline White blood cell count at 12 months | Baseline and 12 months | White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils. |
| Change from Baseline blood rheological properties at 6 months | Baseline and 6 months | Red blood cell count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, platelet count, platelet distribution width, mean platelet volume, plateletcrit |
| Change from 6 month blood rheological properties at 12 months | 6 months and 12 months | Red blood cell count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, platelet count, platelet distribution width, mean platelet volume, plateletcrit |
| Change from Baseline blood rheological properties at 12 months | Baseline and 12 months | Red blood cell count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, platelet count, platelet distribution width, mean platelet volume, plateletcrit |
| Change from Baseline Physical activity level at 6 months | Baseline and 6 months | Physical activity will be assessed by accelerometers |
| Change from 6 months Physical activity level at 12 months | 6 months and 12 months | Physical activity will be assessed accelerometers |
| Change from Baseline Physical activity level at 12 months | Baseline and 12 months | Physical activity will be assessed by accelerometers |
| Change from Baseline Minnesota Physical Activity test at 6 months | Baseline and 6 months | Physical activity assessed by Minnesota Physical Activity test |
| Change from 6 month Minnesota Physical Activity test at 12 months | 6 months and 12 months | Physical activity assessed by Minnesota Physical Activity test |
| Change from Baseline Minnesota Physical Activity test at 12 months | Baseline and 12 months | Physical activity assessed by Minnesota Physical Activity test |
| Change from Baseline number of steps at 6 months | Baseline and 6 months | Physical activity assessed by Pedometers |
| Change from 6 month number of steps at 12 months | 6 months and 12 months | Physical activity assessed by Pedometers |
| Change from Baseline number of steps at 12 months | Baseline and 12 months | Physical activity assessed by Pedometers |
| Change from Baseline chair test at 6 months | Baseline and 6 months | Physical activity assessed by the chair test |
| Change from 6 month chair test at 12 months | 6 months and 12 months | Physical activity assessed by the chair test |
| Change from Baseline chair test at 12 months | Baseline and 12 months | Physical activity assessed by the chair test |
| Change from Baseline sleep quality at 6 months | Baseline and 12 months | Sleep information will be assessed by the Pittsburgh Sleep Quality Index |
| Change from 6 month sleep quality at 12 months | 6 months and 12 months | Sleep information will be assessed by the Pittsburgh Sleep Quality Index |
| Change from Baseline sleep quality at 12 months | Baseline and 12 months | Sleep information will be assessed by the Pittsburgh Sleep Quality Index |
| Change from Baseline Depressive symptoms at 6 months | Baseline and 6 months | Depressive symptoms will be assessed by the Beck Depression Inventory (BDI) |
| Change from 6 month Depressive symptoms at 12 months | 6 months and 12 months | Depressive symptoms will be assessed by the Beck Depression Inventory (BDI) |
| Change from Baseline Depressive symptoms at 12 months | Baseline and 12 months | Depressive symptoms will be assessed by the Beck Depression Inventory (BDI) |
| Change from Baseline Anxiety symptoms at 6 months | Baseline and 6 months | Anxiety symptoms will be assessed by State Anxiety test (STAI) |
| Change from 6 month Anxiety symptoms at 12 months | 6 months and 12 months | Anxiety symptoms will be assessed by State Anxiety test (STAI) |
| Change from Baseline Anxiety symptoms at 12 months | Baseline and 12 months | Anxiety symptoms will be assessed by State Anxiety test (STAI) |
| Single Nucleotide polymorphisms (SNPs) | Baseline | Single nucleotide polymorphisms will be determined by Genomic DNA from oral epithelial cells |
| Change from Baseline DNA methylation at 6 months | Baseline and 6 months | Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development |
| Change from 6 month DNA methylation at 12 months | 6 months and 12 months | Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development |
| Change from Baseline DNA methylation at 12 months | Baseline and 12 months | Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development |
| Change from Baseline microRNAs at 6 months | Baseline and 6 months | Transcriptomic will be assessed by changes in miRNAs |
| Change from 6 month microRNAs at 12 months | 6 months and 12 months | Transcriptomic will be assessed by changes in miRNAs |
| Change from Baseline microRNAs at 12 months | Baseline and 12 months | Transcriptomic will be assessed by changes in miRNAs |
| Change from Baseline Gut microbiota composition at 6 months | Baseline and 6 months | Gut microbiota composition will be analyzed |
| Change from 6 month Gut microbiota composition at 12 month | 6 months and 12 months | Gut microbiota composition will be analyzed |
| Change from Baseline Gut microbiota composition at 12 month | Baseline and 12 months | Gut microbiota composition will be analyzed |
| Change from Baseline metabolites composition of urine at 6 months | Baseline and 6 months | Metabolites composition of urine will be analyzed |
| Change from 6 month metabolites composition of urine at 12 months | 6 months and 12 months | Metabolites composition of urine will be analyzed |
| Change from Baseline metabolites composition of urine at 12 months | Baseline and 12 months | Metabolites composition of urine will be analyzed |
| Change from Baseline metabolites composition of serum at 6 months | Baseline and 6 months | Metabolites composition of serum will be analyzed |
| Change from 6 month metabolites composition of serum at 12 months | 6 months and 12 months | Metabolites composition of serum will be analyzed |
| Change from Baseline metabolites composition of serum at 12 months | Baseline and 12 months | Metabolites composition of serum will be analyzed |
| Change from Baseline dietary intake at 6 months | Baseline and 6 months | Dietary intake will be assessed by means of food frequency questionnaire |
| Change from 6 month dietary intake at 12 months | 6 months and 12 months | Dietary intake will be assessed by means of food frequency questionnaire |
| Change from Baseline dietary intake at 12 months | Baseline and 12 months | Dietary intake will be assessed by means of food frequency questionnaire |
| Assessment of dietary adherence at Baseline | Baseline | Dietary adherence will be assessed by means of 3 day weighed food records |
| Assessment of dietary adherence at 6 months | 6 months | Dietary adherence will be assessed by means of 3 day weighed food records |
| Assessment of dietary adherence at 12 months | 12 months | Dietary adherence will be assessed by means of 3 day weighed food records |
| Change from Baseline satiety index at 6 months | Baseline and 6 months | Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale |
| Change from 6 month satiety index at 12 months | 6 months and 12 months | Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale |
| Change from Baseline satiety index at 12 months | Baseline and 12 months | Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale |
| Change from Baseline life quality index at 6 months | Baseline and 6 months | Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire |
| Change from 6 month life quality index at 12 months | 6 months and 12 months | Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire |
| Change from Baseline life quality index at 12 months | Baseline and 12 months | Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire |
| Change from Baseline Ghrelin concentration at 6 months | Baseline and 6 months | Serum Active Ghrelin will be determined to assess satiety |
| Change from 6 month Ghrelin concentration at 12 months | 6 months and 12 months | Serum Active Ghrelin will be determined to assess satiety |
| Change from Baseline Ghrelin concentration at 12 months | Baseline and 12 months | Serum Active Ghrelin will be determined to assess satiety |
| Change from Baseline glucagon-like peptide-1 (GLP-1) concentration at 6 months | Baseline and 6 months | Serum active glucagon-like peptide-1 will be determined to assess satiety |
| Change from Baseline leptin concentration at 6 months | Baseline and 6 months | Plasma leptin will be assessed to determine inflammatory status |
| Change from Baseline glucagon-like peptide-1 (GLP-1) concentration at 12 months | Baseline and 12 months | Serum active glucagon-like peptide-1 will be determined to assess satiety |
| Change from Baseline Dopamine concentration at 6 months | Baseline and 6 months | Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from 6 month Dopamine concentration at 12 months | 6 months and 12 months | Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from Baseline Dopamine concentration at 12 months | Baseline and 12 months | Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from Baseline Dopac concentration at 6 months | Baseline and 6 months | Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from 6 month Dopac concentration at 12 months | 6 months and 12 months | Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from Baseline Dopac concentration at 12 months | Baseline and 12 months | Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from Baseline Serotonin (5-HT) concentration at 6 months | Baseline and 6 months | Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from 6 month Serotonin (5-HT) concentration at 12 months | 6 months and 12 months | Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from Baseline Serotonin (5-HT) concentration at 12 months | Baseline and 12 months | Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from Baseline Noradrenaline concentration at 6 months | Baseline and 6 months | Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from 6 month Noradrenaline concentration at 12 months | 6 months and 12 months | Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from Baseline Noradrenaline concentration at 12 months | Baseline and 12 months | Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from Baseline 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 6 months | Baseline and 6 months | Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from 6 month 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 12 months | 6 months and 12 months | Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from Baseline 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 12 months | Baseline and 12 months | Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC) |
| Change from 6 month glucagon-like peptide-1 (GLP-1) concentration at 12 months | 6 months and 12 months | Serum active glucagon-like peptide-1 will be determined to assess satiety |
| Change from 6 month leptin concentration at 12 months | 6 months and 12 months | Plasma leptin will be assessed to determine inflammatory status |
| Change from Baseline tumor necrosis factor-α (TNFα) concentration at 12 months | Baseline and 12 months | Plasma TNF-alpha will be assessed to determine inflammatory status |
Countries
Spain
Contacts
Primary ContactM. Angeles Zulet, PhD
Backup ContactItziar Abete, PhD
Outcome results
None listed