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

Gastrointestinal Dysfunction Clinical Trial

— NECTAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187950
• Other study ID #: 20121
• Status: Completed
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: November 2, 2022

Study information

• Verified date: July 2023
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition - Other
• Gastrointestinal Dysfunction
• Physiological Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	National Honey Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Digestive health measured using daily stool records with the Bristol Stool Scale	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.	2 weeks
Secondary	Digestive health measured using rating scales of additional symptoms in daily stool records	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.	2 weeks
Secondary	Digestive health measured using the Gastrointestinal Tolerability questionnaire	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.	2 weeks
Secondary	Digestive health measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire	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.	2 weeks
Secondary	Mood measured using the Emotional Image Task	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 participant valence, arousal, and dominance ratings.	2 weeks
Secondary	Mood measured using the Positive and Negative Affect Schedule (PANAS) questionnaire	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.	2 weeks
Secondary	Mood measured using the Depression, Anxiety, and Stress Scales-42 (DASS-42) questionnaire	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.	2 weeks
Secondary	Mood measured using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires	Determine the impact of consumption of daily yogurt with honey on mood states compared to control (yogurt containing heat-inactivated B. lactis) using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires. Specific PROMIS questionnaires utilized included PROMIS SF v1.0 - Anger 8a, PROMIS SF v1.0 - Anxiety 8a, PROMIS SF v1.0 - Fatigue 8a, PROMIS SF v1.0 - Positive Affect 15a, PROMIS SF v1.0 - Self-Efficacy Manage Emotions 8a, PROMIS SF v1.0 - Fatigue 13a (FACIT-Fatigue), PROMIS SF v1.1 - Global Health, and PROMIS SF v2.0 - Cognitive Function 8a. PROMIS. Surveys were scored using the recommended HealthMeasures Scoring Service.	2 weeks
Secondary	Cognitive function assessed using the Spatial Reconstruction Task	Determine the impact of consumption of daily yogurt with honey on cognitive function compared to control (yogurt containing heat-inactivated B. lactis) using the Spatial Reconstruction Task. This task requires participants to successfully encode and retrieve information pertaining to the position of six objects in relation to each other, necessitating recruitment of the hippocampal memory system.	2 weeks
Secondary	Gastrointestinal microbiota assessed using relative abundances	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.	2 weeks