Clinical trial NCT04187950: NECTAR Study: Nectar (Honey) Effects on Comfort, Thoughts, and Regularity
Official title: NECTAR Study: Nectar (Honey) Effects on Comfort, Thoughts, and Regularity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Dysfunction
Physiological Stress
Cognition - Other
Keywords: gastrointestinal transit time, mood, emotion
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Honey Board
First posted: 2019-12-05
Enrollment: 66
Sex: ALL
Minimum age (years): 22
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, controlled, single-blind, crossover study with two 2-week treatment conditions separated by at least a 4-week washout period between conditions. Participant flow through the study conditions will be counterbalanced. Participants will be randomly allocated to yogurt with honey first or control first.
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to test the central hypothesis that adding to the diet daily yogurt with honey provides beneficial effects on digestive health and subjective mood in healthy adults.

Detailed description: This clinical trial will be a randomized, controlled, double-blind, crossover study with two 2-week treatment conditions separated by at least a 4-week washout period between conditions. Participant flow through the study conditions will be counterbalanced. Participants will be randomly allocated to yogurt with honey first or control first. Before beginning the first intervention period, participants will undergo a 2-week lead-in period that is 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.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Between the ages of 22-64 years at the time of consent
* Body mass index of 18.5 to 29.9 kg/m\^2.
* Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
* Ability to drop off fecal sample within 30 minutes of defecation
* Have between 3-6 bowel movements per week

Exclusion Criteria:

* Current pregnancy, lactation, or post-menopausal
* Tobacco use
* Honey allergy or intolerance
* Dairy allergy, lactose intolerance
* Food dye allergy/intolerance
* Prior physician diagnosed gastrointestinal disease (chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, or gastroesophageal reflux disease (GERD))
* Current use or use of antibiotics in the past 3 months
* Current use of any of the following types of medications: laxatives, anti-diarrhea medications, narcotics, enemas, antispasmodics, anticonvulsants, prescription proton pump inhibitors, prokinetic agents, histamine-2 Rc antagonists (prescription GERD medication)
* Body mass index \> 29.9 kg/m\^2
* Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy)
* Restrictive bariatric surgery (i.e. adjustable gastric band) within the past 5 years
* Concurrent enrollment in another dietary, exercise, or medication study

Primary outcomes:
measure: Intestinal transit time measured using colored dye markers
timeFrame: 2 weeks
Secondary outcomes:
measure: Digestive health measured using daily stool records with the Bristol Stool Scale
timeFrame: 2 weeks
measure: Digestive health measured using rating scales of additional symptoms in daily stool records
timeFrame: 2 weeks
measure: Digestive health measured using the Gastrointestinal Tolerability questionnaire
timeFrame: 2 weeks
measure: Digestive health measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire
timeFrame: 2 weeks
measure: Mood measured using the Emotional Image Task
timeFrame: 2 weeks
measure: Mood measured using the Positive and Negative Affect Schedule (PANAS) questionnaire
timeFrame: 2 weeks
measure: Mood measured using the Depression, Anxiety, and Stress Scales-42 (DASS-42) questionnaire
timeFrame: 2 weeks
measure: Mood measured using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires
timeFrame: 2 weeks
measure: Cognitive function assessed using the Spatial Reconstruction Task
timeFrame: 2 weeks
measure: Gastrointestinal microbiota assessed using relative abundances
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
References: