Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Intestinal transit time measured using colored dye markers |
Determine the impact of consumption of daily yogurt with honey on intestinal transit time in vivo compared to control, yogurt containing heat-inactivated B.lactis with added sugar. Intestinal transit time will be measured using colored dye markers. |
2 weeks |
|
Secondary |
Digestive health measured using daily stool records with the Bristol Stool Scale |
Determine the impact of consumption of daily yogurt with honey on digestive health compared to control (yogurt containing heat-inactivated B. lactis) using daily stool records. Within the records, participants rate stool consistency using the Bristol Stool Scale. |
2 weeks |
|
Secondary |
Digestive health measured using rating scales of additional symptoms in daily stool records |
Determine the impact of consumption of daily yogurt with honey on other measures of digestive health compared to control (yogurt containing heat-inactivated B. lactis) using daily stool records. Within the records, ratings of additional gastrointestinal symptoms include ease of passage, abdominal pain, bloating, burping, flatulence, nausea, reflux, and rumblings. |
2 weeks |
|
Secondary |
Digestive health measured using the Gastrointestinal Tolerability questionnaire |
Determine the impact of consumption of daily yogurt with honey on other measures of digestive health compared to control (yogurt containing heat-inactivated B. lactis) using the Gastrointestinal Tolerability questionnaire. This questionnaire assesses gastrointestinal health through 6 questions related to gastrointestinal health including nausea, bloating, rumblings, gas/flatulence, abdominal pain, and diarrhea. Each of the questions pertains to experience of symptoms in the past 7 days. |
2 weeks |
|
Secondary |
Digestive health measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire |
Determine the impact of consumption of daily yogurt with honey on other measures of digestive health compared to control (yogurt containing heat-inactivated B. lactis) using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire. The GIQLI assesses gastrointestinal health through a series of 36 questions pertaining to daily life and gastrointestinal symptoms experienced in the past 2 weeks. |
2 weeks |
|
Secondary |
Mood measured using the Emotional Image Task |
Determine the impact of consumption of daily yogurt with honey on mood states compared to control (yogurt containing heat-inactivated B. lactis) using the Emotional Image Task. This task measures response to neutral, positive, and negative image stimuli using participant valence, arousal, and dominance ratings. |
2 weeks |
|
Secondary |
Mood measured using the Positive and Negative Affect Schedule (PANAS) questionnaire |
Determine the impact of consumption of daily yogurt with honey on mood states compared to control (yogurt containing heat-inactivated B. lactis) using the Positive and Negative Affect Schedule (PANAS) questionnaire. The PANAS assesses general mood using a 20-item scale that includes words associated with either positive (10 words) or negative (10 words) emotions. |
2 weeks |
|
Secondary |
Mood measured using the Depression, Anxiety, and Stress Scales-42 (DASS-42) questionnaire |
Determine the impact of consumption of daily yogurt with honey on mood states compared to control (yogurt containing heat-inactivated B. lactis) using the Depression, Anxiety, and Stress Scales-42 (DASS-42) questionnaire. The DASS-42 includes subscales with 42 questions regarding negative emotional states and is used to assess mental health over the past week. |
2 weeks |
|
Secondary |
Mood measured using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires |
Determine the impact of consumption of daily yogurt with honey on mood states compared to control (yogurt containing heat-inactivated B. lactis) using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires. Specific PROMIS questionnaires utilized included PROMIS SF v1.0 - Anger 8a, PROMIS SF v1.0 - Anxiety 8a, PROMIS SF v1.0 - Fatigue 8a, PROMIS SF v1.0 - Positive Affect 15a, PROMIS SF v1.0 - Self-Efficacy Manage Emotions 8a, PROMIS SF v1.0 - Fatigue 13a (FACIT-Fatigue), PROMIS SF v1.1 - Global Health, and PROMIS SF v2.0 - Cognitive Function 8a. PROMIS. Surveys were scored using the recommended HealthMeasures Scoring Service. |
2 weeks |
|
Secondary |
Cognitive function assessed using the Spatial Reconstruction Task |
Determine the impact of consumption of daily yogurt with honey on cognitive function compared to control (yogurt containing heat-inactivated B. lactis) using the Spatial Reconstruction Task. This task requires participants to successfully encode and retrieve information pertaining to the position of six objects in relation to each other, necessitating recruitment of the hippocampal memory system. |
2 weeks |
|
Secondary |
Gastrointestinal microbiota assessed using relative abundances |
Determine the impact of daily consumption of yogurt with honey on the gastrointestinal microbiota compared to control (yogurt containing heat-inactivated B. lactis). Relative abundances of the gastrointestinal microbiota will be measured with 16S amplicon sequencing. |
2 weeks |
|