NCT04187950

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University of Illinois at Urbana-Champaign · Academic / Other
• Sex: All
• Age: 22 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastrointestinal Dysfunction
• Physiological Stress
• Cognition - Other

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Yogurt with B. lactis and added honey	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.
DIETARY_SUPPLEMENT	Yogurt with heat-inactivated B. lactis and added cane sugar	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.

Timeline

• Start date: 2021-05-19
• Primary completion: 2022-11-02
• Completion: 2022-11-02
• First posted: 2019-12-05
• Last updated: 2023-07-21

Locations

1 site across 1 country: United States