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| Name | Class |
|---|---|
| National Honey Board | OTHER |
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This study aims to test the central hypothesis that adding to the diet daily yogurt provides beneficial effects on digestive health and subjective mood in healthy adults.
This clinical trial will include a 4-week lead-in period and a 2-week treatment period. The lead-in period will be devoid of all supplemental and dietary probiotics, fermented dairy products, and fermented foods. Participants will be asked to refrain from consuming all supplemental and dietary probiotics, fermented dairy products, and fermented foods throughout the entire study. During the treatment period, participants will be given yogurt with sugar. This trial will serve as a continuation of the NECTAR Study (NCT04187950).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yogurt with B. lactis and added cane sugar | Experimental | Participants will consume yogurt with B. lactis and added cane sugar twice daily for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yogurt with B. lactis and added cane sugar | Dietary Supplement | The intervention condition will utilize a commercially available yogurt (Activia) that contains Bifidobacterium animalis lactis DN-173 010/CNCM I-2494 (B. lactis). Participants will consume 170 g of yogurt with cane sugar twice daily for 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal transit time measured using colored dye markers | Determine the impact of consumption of daily yogurt with sugar on intestinal transit time in vivo. Intestinal transit time will be measured using colored dye markers. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Digestive health measured using daily stool records with the Bristol Stool Scale | Determine the impact of consumption of daily yogurt with sugar on digestive health using daily stool records. Within the records, participants rate stool consistency using the Bristol Stool Scale (1=hard to 7=watery). | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Urbana-Champaign | Urbana | Illinois | 61801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38830472 | Derived | Mysonhimer AR, Brown MD, Alvarado DA, Cornman E, Esmail M, Abdiel T, Gutierrez K, Vasquez J, Cannavale CN, Miller MJ, Khan NA, Holscher HD. Honey Added to Yogurt with Bifidobacterium animalis subsp. lactis DN-173 010/CNCM I-2494 Supports Probiotic Enrichment but Does Not Reduce Intestinal Transit Time in Healthy Adults: A Randomized, Controlled, Crossover Trial. J Nutr. 2024 Aug;154(8):2396-2410. doi: 10.1016/j.tjnut.2024.05.028. Epub 2024 Jun 1. |
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| ID | Term |
|---|---|
| D015014 | Yogurt |
| ID | Term |
|---|---|
| D043302 | Cultured Milk Products |
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
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Controlled single-group trial with a 4-week lead-in period and a 2-week treatment period. The treatment will consist of yogurt with sugar.
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Participants will be blinded to the ingredient (sugar) added to the yogurt.
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| Digestive health measured using rating scales of additional symptoms in daily stool records |
Determine the impact of consumption of daily yogurt with sugar on other measures of digestive health using daily stool records. Within the records, ratings of additional gastrointestinal symptoms include ease of passage (1=very easy to 5=very difficult, abdominal pain, bloating, burping, flatulence, nausea, reflux, and rumblings (1=absent to 4=severe). |
| 2 weeks |
| Digestive health measured using the Gastrointestinal Tolerability questionnaire | Determine the impact of consumption of daily yogurt with sugar on other measures of digestive health 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 ("no more than usual" to "much more than usual"). Each of the questions pertains to experience of symptoms in the past 7 days. | 2 weeks |
| Digestive health measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire | Determine the impact of consumption of daily yogurt with sugar on other measures of digestive health 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 |
| Mood measured using the Emotional Image Task | Determine the impact of consumption of daily yogurt with sugar on mood states 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 |
| Mood measured using the Positive and Negative Affect Schedule (PANAS) questionnaire | Determine the impact of consumption of daily yogurt with sugar on mood states 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 |
| Mood measured using the Depression, Anxiety, and Stress Scales-42 (DASS-42) questionnaire | Determine the impact of consumption of daily yogurt with sugar on mood states 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. The rating scale for each question is 0="did not apply to me at all" to 3="applied to me very much, or most of the time." Lower scores indicate none or less symptoms of depression, anxiety, or stress. | 2 weeks |
| Mood measured using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires | Determine the impact of consumption of daily yogurt with sugar on mood states using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires. Specific PROMIS surveys 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 |
| Cognitive function measured using the Spatial Reconstruction Task | Determine the impact of consumption of daily yogurt with sugar 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 |
| Gastrointestinal microbiota assessed using relative abundances | Determine the impact of daily consumption of yogurt with sugar on the gastrointestinal microbiota. Relative abundances of the gastrointestinal microbiota will be measured with 16S amplicon sequencing. | 2 weeks |
| D010829 |
| Physiological Phenomena |
| D000074421 | Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |