Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Frequency of appearance of the total clinical manifestations due to the consumption of both products |
The proportion of participants that reported at least one adverse event, which refers to the total of clinical manifestations due to the consumption of both products. Symptoms that were considered: nausea, heartburn, abdominal pain, gas/swelling, diarrhea, vomits, metallic taste, constipation, headache and respiratory distress. |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Frequency of appearance of each of the total clinical manifestations due to the consumption of both products |
The proportion of participants that reported at least one adverse event, which refers to each of the total of clinical manifestations due to the consumption of both products (individual symptoms that were considered: nausea, heartburn, abdominal pain, gas/swelling, diarrhea, vomits, metallic taste, constipation, headache and respiratory distress) |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Change in the total number of incidences/complaints related to the study product |
Symptoms: nausea, heartburn, abdominal pain, gas/swelling, diarrhea, vomits, metallic taste, constipation, headache, and respiratory distress |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Number of clinical manifestations that subjects experience |
Symptoms: nausea, heartburn, abdominal pain, gas/swelling, diarrhea, vomits, metallic taste, constipation, headache, and respiratory distress |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Overall intensity of clinical manifestations that subjects experience (nausea, heartburn, abdominal pain, gas/swelling) |
Intensity was measured with VAS scale |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Overall intensity of clinical manifestations that subjects experience (diarrhea and vomits) |
Intensity was measured with number of times. |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Change in the acute intensity of adverse effects that subjects experience |
Symptoms: Nausea, heartburn, abdominal pain, gas/swelling, vomits, diarrhea, constipation, metallic taste, headache, and respiratory distress |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Duration (number of days) of clinical manifestation |
This variable was measured in total duration (number of days) of symptom onset (symptoms: nausea, heartburn, abdominal pain, metallic taste, headache, diarrhea, constipation, gas/swelling, respiratory distress and vomits) |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Duration (minutes per day) of clinical manifestation |
Daily duration (minutes) of symptom (nausea, heartburn, abdominal pain, gas, metallic taste, headache, and respiratory distress) |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Health status using VAS scale |
Health status (daily and with respect to the previous day) |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Physical activity |
Proportion of participants that experienced any impact on daily activity |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Bowel movements |
Number of times subjects go to the toilet. |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Stool morphology |
Stool type (Bristol scale) |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Sleep quality |
Sleep quality measured on a scale of 1 to 5 (1 being poor sleep quality and 5 being very good sleep quality). |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Sleep duration |
Number of hours subjects sleep |
This variable will measure the changes in clinical manifestations during the period of each of the intakes, i.e., for 14 days, and during the washout period. |
|
Secondary |
Ferritin |
Iron profile. By means of a blood draw. |
Day 1 and day 14 of each product consumption. |
|
Secondary |
Saturated transferrin |
Iron profile. By means of a blood draw. |
Day 1 and day 14 of each product consumption. |
|
Secondary |
Serum iron |
Iron profile. By means of a blood draw. |
Day 1 and day 14 of each product consumption. |
|
Secondary |
Hemoglobin |
Iron profile. By means of a blood draw. |
Day 1 and day 14 of each product consumption. |
|
Secondary |
Safety variables |
Safety parameters (physical examination, vital signs, blood and urine laboratory tests, adverse events other than expected in the study) |
Day 1 and day 14 of each product consumption. |
|