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

NCT04187950 | Completed

• 1 other identifier: 20121
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Dysfunction; Physiological Stress; Cognition - Other

Keywords

gastrointestinal transit time, mood, emotion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Digestive health measured using daily stool records with the Bristol Stool Scale

  2 weeks

• Digestive health measured using rating scales of additional symptoms in daily stool records

  2 weeks

• Digestive health measured using the Gastrointestinal Tolerability questionnaire

  2 weeks

• Digestive health measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire

  2 weeks

• Mood measured using the Emotional Image Task

  2 weeks

Study Arms (2)

Yogurt with inactivated B. lactis and added cane sugar

PLACEBO COMPARATOR

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

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

Yogurt with B. lactis and added honey

EXPERIMENTAL

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

Dietary Supplement: Yogurt with B. lactis and added honey

Interventions

Yogurt with B. lactis and added honey 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 honey twice daily for 14 days.

Also known as: Treatment

Yogurt with B. lactis and added honey

Yogurt with heat-inactivated B. lactis and added cane sugar DIETARY_SUPPLEMENT

The control condition will utilize a commercially available yogurt (Activia) following heat inactivation of the probiotic Bifidobacterium animalis lactis DN-173 010/CNCM I-2494 (B. lactis). Participants will consume 170 g of the heat-inactivated yogurt with added cane sugar twice daily for 14 days.The added cane sugar will be an isocaloric amount to the honey.

Also known as: Control

Yogurt with inactivated B. lactis and added cane sugar

Eligibility Criteria

• Age: 22 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• National Honey Board: collaborator

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

• 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.

  PMID: 38830472 DERIVED

MeSH Terms

Interventions

Yogurt; Therapeutics

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the order in which they receive the study treatments.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: December 5, 2019
• Study Start: May 19, 2021
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

US (1)