Gastrointestinal DysfunctionNECTARNCT04187950
NECTAR Study: Nectar (Honey) Effects on Comfort, Thoughts, and Regularity
A study testing Yogurt with B. lactis and added honey and Yogurt with heat-inactivated B. lactis and added cane sugar in people with Gastrointestinal Dysfunction and Physiological Stress, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Dysfunction, Physiological Stress, Cognition - Other
- What is being tested?
- Yogurt with B. lactis and added honey and Yogurt with heat-inactivated B. lactis and added cane sugar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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))
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
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.
Read the 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.
- Being tested
- Yogurt with B. lactis and added honey, Yogurt with heat-inactivated B. lactis and added cane sugar
- Keywords
- gastrointestinal transit time, mood, emotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt with B. lactis and added honeyDietary supplement
Also called Treatment
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 sugarDietary supplement
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Yogurt with B. lactis and added honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (10)
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start19 May 2021
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Honey Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187950
- Sponsor's protocol ID
- 20121
- Acronym
- NECTAR
- Status last verified
- Jul 2023
- First submitted
- 2 Oct 2019
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38830472
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NECTAR Study: Nectar (Honey) Effects on Comfort, Thoughts, and Regularity
- ClinicalTrials.gov ID
- NCT04187950
- Acronym / sponsor ID
- NECTAR / 20121
- Keywords
- gastrointestinal transit time, mood, emotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Honey Board
- Study start
- 19 May 2021 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Yogurt with inactivated B. lactis and added cane sugar | Placebo comparator | Dietary Supplement: Yogurt with heat-inactivated B. lactis and added cane sugarParticipants will consume yogurt with heat inactivated B. lactis and added cane sugar twice daily for 14 days. |
| Yogurt with B. lactis and added honey | Experimental | Dietary Supplement: Yogurt with B. lactis and added honeyParticipants will consume yogurt with B. lactis and added honey twice daily for 14 days. |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Current pregnancy, lactation, or post-menopausal
- Tobacco use
- Honey allergy or intolerance
- Dairy allergy, lactose intolerance
- Food dye allergy/intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt with B. lactis and added honeyAlso: TreatmentThe 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 B. lactis and added honey |
| Yogurt with heat-inactivated B. lactis and added cane sugarAlso: ControlThe 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. | Dietary supplement | Yogurt with inactivated B. lactis and added cane sugar |
Primary outcome
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.
10 secondary outcomes
Digestive health measured using daily stool records with the Bristol Stool Scale
Time frame: 2 weeks
Digestive health measured using rating scales of additional symptoms in daily stool records
Time frame: 2 weeks
Digestive health measured using the Gastrointestinal Tolerability questionnaire
Time frame: 2 weeks
Digestive health measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire
Time frame: 2 weeks
Mood measured using the Emotional Image Task
Time frame: 2 weeks
Mood measured using the Positive and Negative Affect Schedule (PANAS) questionnaire
Time frame: 2 weeks
Mood measured using the Depression, Anxiety, and Stress Scales-42 (DASS-42) questionnaire
Time frame: 2 weeks
Mood measured using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires
Time frame: 2 weeks
Cognitive function assessed using the Spatial Reconstruction Task
Time frame: 2 weeks
Gastrointestinal microbiota assessed using relative abundances
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 38830472Mysonhimer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt with B. lactis and added honey and Yogurt with heat-inactivated B. lactis and added cane sugar in people with Gastrointestinal Dysfunction and Physiological Stress, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal transit time measured using colored dye markers (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.