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The aim of this study is to design and validate a test, METAHEALTH-TEST, based in gene expression analysis in blood cells, to quickly and easily analyse metabolic health. This test will be used to analyse metabolic improvement in overweight/obese individuals and in metabolically obese normal-weight (MONW) individuals after undergoing a weight loss intervention and/or an intervention for improvement in eating habits and lifestyle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal-weight (NW) | No Intervention | Individuals with BMI<25 kg/m2 | |
| Overweight-Obese (OW-OB) | Experimental | Individuals with BMI>25 kg/m2, submitted to a nutritional intervention (hypocaloric balanced diet) during 6 months and prescription of physical activity to achieve weigh loss |
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| Metabolically obese normal-weight (MONW) | Experimental | Individuals with BMI<25 kg/m2, with metabolic alterations related to obesity (hypertriglyceridemia, hypercholesterolemia, hyperglycaemia, hypertension or high waist-hip ratio), submitted to an intervention to improve dietary habits and physical activity in order to achieve a better body composition and metabolic health. Mediterranean diet will be and aerobic and strength exercises will be advised to these individuals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary and physical activity intervention | Other | OW-OB group: 6-month program of weight loss consisting in a low-calorie food plan (30% reduction in the individual energy requirements) with dietary sessions and exercise counselling. MONW group: 6-month program to improve eating habits (Mediterranean diet) with dietary sessions and exercise counselling. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells | The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray | Baseline point (all groups) |
| Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells | The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray | 3 months (OW-OB and MONW groups) |
| Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells | The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray | 6 months (OW-OB and MONW groups) |
| Weight | Weight (kg) | Baseline point (all groups) |
| Weight | Weight (kg) | 3 months (OW-OB and MONW groups) |
| Weight | Weight (kg) | 6 months (OW-OB and MONW groups) |
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2). | Baseline point (all groups) |
| Body Mass Index (BMI) |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Height (m) | Baseline point (all groups) |
| Height | Height (m) | 3 months (OW-OB and MONW groups) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Balearic Islands | Palma de Mallorca | Balearic Islands | 07122 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33978191 | Derived | Costa A, Konieczna J, Reynes B, Martin M, Fiol M, Palou A, Romaguera D, Oliver P. CUN-BAE Index as a Screening Tool to Identify Increased Metabolic Risk in Apparently Healthy Normal-Weight Adults and Those with Obesity. J Nutr. 2021 Aug 7;151(8):2215-2225. doi: 10.1093/jn/nxab117. |
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IPD will be shared in due time if considered relevant for other research. With our current objectives, it is not considered necessary.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Volunteers are assigned to three groups for the duration of the study:
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|
Weight and height will be combined to report BMI in kg/m^2). |
| 3 months (OW-OB and MONW groups) |
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2). | 6 months (OW-OB and MONW groups) |
| Body composition | Body composition (fat mass in kg) measured using a DXA scanner | Baseline point (all groups) |
| Body composition | Body composition (fat mass in kg) measured using a DXA scanner | 3 months (OW-OB and MONW groups) |
| Body composition | Body composition (fat mass in kg) measured using a DXA scanner | 6 months (OW-OB and MONW groups) |
| Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP) | Circulating parameters measured in mg/dL | Baseline point (all groups) |
| Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP) | Circulating parameters measured in mg/dL | 3 months (OW-OB and MONW groups) |
| Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP) | Circulating parameters measured in mg/dL | 6 months (OW-OB and MONW groups) |
| Circulating gamma-glutamyl transpeptidase (GGT) | GGT measured in U/L | Baseline point (all groups) |
| Circulating gamma-glutamyl transpeptidase (GGT) | GGT measured in U/L | 3 months (OW-OB and MONW groups) |
| Circulating gamma-glutamyl transpeptidase (GGT) | GGT measured in U/L | 6 months (OW-OB and MONW groups) |
| Height | Height (m) | 6 months (OW-OB and MONW groups) |
| Waist-hip ratio | Waist-hip ratio | Baseline point (all groups) |
| Waist-hip ratio | Waist-hip ratio | 3 months (OW-OB and MONW groups) |
| Waist-hip ratio | Waist-hip ratio | 6 months (OW-OB and MONW groups) |
| Blood pressure | Blood pressure (mm Hg) | Baseline point (all groups) |
| Blood pressure | Blood pressure (mm Hg) | 3 months (OW-OB and MONW groups) |
| Blood pressure | Blood pressure (mm Hg) | 6 months (OW-OB and MONW groups) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |