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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Placebo Comparator: Yogurt with inactivated B. lactis and added cane sugar
    • Participants will consume yogurt with heat inactivated B. lactis and added cane sugar twice daily for 14 days.
  • Experimental: Yogurt with B. lactis and added honey
    • Participants will consume yogurt with B. lactis and added honey twice daily for 14 days.

Clinical Trial Outcome Measures

Primary Measures

  • Intestinal transit time measured using colored dye markers
    • Time Frame: 2 weeks
    • 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.

Secondary Measures

  • Digestive health measured using daily stool records with the Bristol Stool Scale
    • Time Frame: 2 weeks
    • Determine the impact of consumption of daily yogurt with honey on digestive health compared to control (yogurt containing heat-inactivated B. lactis) using daily stool records. Within the records, participants rate stool consistency using the Bristol Stool Scale.
  • Digestive health measured using rating scales of additional symptoms in daily stool records
    • Time Frame: 2 weeks
    • Determine the impact of consumption of daily yogurt with honey on other measures of digestive health compared to control (yogurt containing heat-inactivated B. lactis) using daily stool records. Within the records, ratings of additional gastrointestinal symptoms include ease of passage, abdominal pain, bloating, burping, flatulence, nausea, reflux, and rumblings.
  • Digestive health measured using the Gastrointestinal Tolerability questionnaire
    • Time Frame: 2 weeks
    • Determine the impact of consumption of daily yogurt with honey on other measures of digestive health compared to control (yogurt containing heat-inactivated B. lactis) 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. Each of the questions pertains to experience of symptoms in the past 7 days.
  • Digestive health measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire
    • Time Frame: 2 weeks
    • Determine the impact of consumption of daily yogurt with honey on other measures of digestive health compared to control (yogurt containing heat-inactivated B. lactis) 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.
  • Mood measured using the Emotional Image Task
    • Time Frame: 2 weeks
    • Determine the impact of consumption of daily yogurt with honey on mood states compared to control (yogurt containing heat-inactivated B. lactis) using the Emotional Image Task. This task measures response to neutral, positive, and negative image stimuli using electroencephalography.
  • Mood measured using the Positive and Negative Affect Schedule (PANAS) questionnaire
    • Time Frame: 2 weeks
    • Determine the impact of consumption of daily yogurt with honey on mood states compared to control (yogurt containing heat-inactivated B. lactis) 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.
  • Mood measured using the Depression, Anxiety, and Stress Scales-42 (DASS-42) questionnaire
    • Time Frame: 2 weeks
    • Determine the impact of consumption of daily yogurt with honey on mood states compared to control (yogurt containing heat-inactivated B. lactis) 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.
  • Gastrointestinal microbiota assessed using relative abundances
    • Time Frame: 2 weeks
    • Determine the impact of daily consumption of yogurt with honey on the gastrointestinal microbiota compared to control (yogurt containing heat-inactivated B. lactis). Relative abundances of the gastrointestinal microbiota will be measured with 16S amplicon sequencing.

Participating in This Clinical Trial

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 or lactation
  • Tobacco use
  • Honey allergy or intolerance
  • Dairy allergy, lactose intolerance
  • Food dye allergy/intolerance
  • Prior diagnosis of gastrointestinal disease, chronic constipation, or diarrhea
  • Current use or use of antibiotics in the past 3 months
  • 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

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Illinois at Urbana-Champaign
  • Collaborator
    • National Honey Board
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Hannah D Holscher, PhD, RD, (217) 300-2512, hholsche@illinois.edu

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