Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in ghrelin concentration |
Ghrelin hormone measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is GHRL/Ghrelin ELISA Kit catalog number ELH-GHRL. Ghrelin is measured in pg/mL. |
Baseline, at 30 minutes postprandially, and at 180 minutes postprandially. |
|
Primary |
Change in cholecystokinin concentration |
Cholecystokinin measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is Human CCK Enzyme Immunoassay Kit catalog number EIA-CCK-1. Cholecystokinin is measured in pg/mL. |
Baseline, at 30 minutes postprandially, and at 180 minutes postprandially. |
|
Primary |
Change in dietary intake |
Analysis of the 24 hour dietary intake recall consumed the rest of the day after the intervention. Analyzed with the Nutritionist Pro TM Software. |
Post intervention, the following 24 hours after finishing the intervention |
|
Primary |
Change in appetite feelings |
Hunger, fullness, satiety, desire to eat and prospective consumption are assessed with the visual analog scales (VAS). They are composed of 100 mm long lines, where at one end the term "None" or "Not at all" is placed and at the other end the term "Yes, a lot" or "As much as I have never felt". The patient marks a point between these two extremes and quantification is done by measuring the distance from the left end of the line to the mark which is scored. |
Baseline and in the following 180 minutes postprandially, measured every 30 minutes. |
|
Primary |
Change in desire for specific types of food |
The desire to eat specific foods: sweet, salty, fatty, tasty and thirsty, was evaluated with visual analog scales, consisting of lines in which at one end is placed the term "Yes, very much" and at the other end the term "No, not at all". The patient marks a point between these two extremes and quantification is done by measuring the distance from the left end of the line to the mark, to which a score is given. |
Baseline and in the following 180 minutes postprandially, measured every 30 minutes. |
|
Secondary |
Change in plasma glucose |
Peripheral blood samples were taken by a venous puncture after 12 h of fasting and at 120 min postprandial, and they were immediately centrifuged at 3500 rpm to obtain serum. The serum was separated and stored at -80 ?C for later use. The concentration of glucose, was measured with a dry chemistry analyzer "Vitros 350 Chemistry" (Ortho-Clinical Diagnostics, Johnson & Johnson Services Inc., Rochester, NY, USA). |
Baseline, at 30 minutes postprandially, and at 180 minutes postprandially. |
|
Secondary |
Change in lipid profile: total cholesterol, triglycerides, high density lipoprotein, low-density lipoprotein, very low-density lipoprotein |
Peripheral blood samples were taken by a venous puncture after 12 h of fasting, 30 min and at 180 min postprandial, and they were immediately centrifuged at 3500 rpm to obtain serum. The serum was separated and stored at -80 ?C for later use. The concentration of triglycerides, total cholesterol, and high-density lipoprotein cholesterol (HDL-c) cholesterol was measured with a dry chemistry analyzer Vitros 350 Chemistry (Ortho-Clinical Diagnostics, Johnson & Johnson Services Inc., Rochester, NY, USA). Low-density lipoprotein cholesterol (LDL-c) was calculated with the Friedewald formula, except when triglycerides levels were higher than 400 mg/dL. Very-low-density lipoprotein cholesterol (VLDL-c) was calculated as total cholesterol minus the sum of LDL-c + HDL-c. |
Baseline, at 30 minutes postprandially, and at 180 minutes postprandially. |
|
Secondary |
24 hour dietary intake recall pre-intervention |
Analysis of the 24 hour dietary intake recall consumed the day previous to the intervention. Analyzed with the Nutritionist Pro TM Software. |
Baseline |
|
Secondary |
Physical activity |
It is evaluated with the International Physical Activity Questionnaire (IPAQ). The questionnaire allows to obtain a quantitative calculation of the MET's (metabolic equivalents), which are a measure that expresses the energetic cost of physical activities. A higher score indicates greater physical activity. The minimum value is 3.3 MET´s /minute/week and there is no a maximum value. |
Baseline |
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