NECTAR Study: Nectar (Honey) Effects on Comfort, Thoughts, and Regularity

University of Illinois at Urbana-Champaign

Status: Completed

Conditions: Cognition - Other; Physiological Stress; Gastrointestinal Dysfunction

Treatments: Dietary Supplement: Yogurt with heat-inactivated B. lactis and added cane sugar; Dietary Supplement: Yogurt with B. lactis and added honey

Study type: Interventional

Funder types: Other

Identifiers

NCT04187950

20121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 22 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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66 participants in 2 patient groups, including a placebo group

Yogurt with inactivated B. lactis and added cane sugar

Placebo Comparator group

Description:

Participants will consume yogurt with heat inactivated B. lactis and added cane sugar twice daily for 14 days.

Treatment:

Dietary Supplement: Yogurt with heat-inactivated B. lactis and added cane sugar

Yogurt with B. lactis and added honey

Experimental group

Description:

Participants will consume yogurt with B. lactis and added honey twice daily for 14 days.

Treatment:

Dietary Supplement: Yogurt with B. lactis and added honey