Microbial ColonizationPHMTimingNCT06938386
Pilot Haskap Metabolite Timing Project
A study testing Haskap in people with Microbial Colonization and Metabolic Disease, run by Montana State University at 1 site in United States.
Trial summary
Diet is a key factor in managing health and individuals at risk of developing metabolic syndrome or other chronic diseases have the opportunity to use diet as a tool to improve their health. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Metabolic Disease, Digestion
- What is being tested?
- Haskap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old
- Body mass index (BMI) between 18-30 kg/m^2
Who cannot join
- allergy to Haskap berries
- have taken antibiotics in the last 90 days
- take dietary supplements
- have adverse events from blood draws
- take medication to lower cholesterol, inflammation, lipids
- smoke cigarettes
Show all 9Show fewer
- pregnant and/or lactating
- have diabetes
- are unwilling to follow a no-polyphenolic diet for 10 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haskap Berry Derived Plasma Metabolites - Pilot Timing Project
Diet is a key factor in managing health and individuals at risk of developing metabolic syndrome or other chronic diseases have the opportunity to use diet as a tool to improve their health. This can be complicated when considering the numerous variables that impact digestion and absorption of key health-promoting compounds in foods. One of these variables is the gut microbiome, a microbial community in the digestive tract that interacts with the foods we consume. The mechanisms the microbiome uses to interact with bioactive compounds in foods, like polyphenols, can modulate the health-promoting benefits of polyphenols. Polyphenols are secondary plant metabolites, commonly found in fruit, legumes, chocolate, coffee, and nuts among other foods that have been shown to improve cardiovascular and metabolic health, as well as reduce inflammation and oxidative stress.
Read the detailed description
Haskap berries (Lonicera caerulea L.), also known as Blue Honeysuckle or Honeyberry, are a polyphenol rich berry that has a greater polyphenolic content than other commonly consumed berries, like strawberries or blueberries. Haskap berries are unique, having a greater content of polyphenols compared to other foods, specifically cyanidin-3-glucoside. Cyanidin-3-glucoside is an anthocyanin shown to reduce inflammation and cardioprotective effects. There is a growing body of literature describing the impact of berry consumption on metabolic health; however, Haskap berry specific investigations in human participants are limited. Currently, Haskap berry consumption shows promising findings in research related to glycemic control, oxidative stress, and inflammation in in-vitro and mice models. The benefits of Haskap berries as a functional food are highly encouraging in animal models, but translational research to demonstrate beneficial health impacts in humans is needed.
A crucial aspect of polyphenol metabolism is the role of the gut microbiome, which influences both metabolic responses to polyphenol consumption and the bioavailability of polyphenolic metabolites. Polyphenol digestion differs based on the structure of the polyphenol and what area of digestive tract is being considered. In the mouth, mastication and salivary enzymes begin the digestion process. However, polyphenols bind with salivary proteins, like tannin-binding salivary proteins, that inhibit their breakdown and subsequent absorption. In the stomach, a limited amount of polyphenols are broken down and/or absorbed and other are conjugated with glucuronic acid. In the small intestine, polyphenols are hydrolyzed into smaller subunits to be absorbed by both passive and active transport. Lastly, the large intestine is the most important segment of digestion to consider.
One of the challenges of polyphenolic research is the intricate relationship between the gut microbiota and the absorption of polyphenolic compounds. Bacteria in the gut are responsible for the majority of polyphenol digestion. Bacteria in the gut interact with polyphenols in a variety of biotransformation reactions including esterification, dehydroxylation, reduction, and decarboxylation. Certain bacteria in the gut have the ability to perform these reactions with polyphenols, including but not limited to Flavonifractor plautii and Bifidobacterium spp. Polyphenol consumption has been shown to modulate microbial composition; however, this project aims to understand how the microbiome impacts metabolite abundance.
This project aims to bridge an important gap that is how the gut microbiome impacts dietary polyphenol absorption and metabolism and how this impacts the health-promoting compounds in Haskap berries. The purpose of this research proposal is to investigate how the microbiome impacts metabolism of polyphenols from Haskap berries. Overarching hypothesis: The composition of bacteria in the gut of participants will impact the Haskap-related metabolites produced
- Conditions
- Microbial Colonization, Metabolic Disease, Digestion
- Being tested
- Haskap
- Keywords
- Polyphenols, Plasma metabolome, Microbial Metabolism, Metabolomics
- Medical subject headings
- Communicable Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaskapDietary supplement
A whole, frozen Haskap berry puree blended with water in a 2:1 ratio of berry to water.
| Study group | Role | What they receive |
|---|---|---|
| Haskap | Experimental | Haskap puree will be consumed by all participants after a fasting blood sample is collected Receives: Dietary Supplement: Haskap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolite Abundance
Relative abundance of metabolites and degradation products of Haskap berries
Measured: 48 hours
Metabolite Identity
Identify metabolites with fragmentation MS/MS data
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 May 2025
- Primary completion30 Jun 2025
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary P Miles, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938386
- Sponsor's protocol ID
- 2024-2029
- Acronym
- PHMTiming
- Status last verified
- Aug 2025
- First submitted
- 14 Apr 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haskap Berry Derived Plasma Metabolites - Pilot Timing Project
- ClinicalTrials.gov ID
- NCT06938386
- Acronym / sponsor ID
- PHMTiming / 2024-2029
- Conditions
- Microbial Colonization, Metabolic Disease, Digestion
- Keywords
- Polyphenols, Plasma metabolome, Microbial Metabolism, Metabolomics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 22 Apr 2025 (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.
Diet is a key factor in managing health and individuals at risk of developing metabolic syndrome or other chronic diseases have the opportunity to use diet as a tool to improve their health. This can be complicated when considering the numerous variables that impact digestion and absorption of key health-promoting compounds in foods. One of these variables is the gut microbiome, a microbial community in the digestive tract that interacts with the foods we consume. The mechanisms the microbiome uses to interact with bioactive compounds in foods, like polyphenols, can modulate the health-promoting benefits of polyphenols. Polyphenols are secondary plant metabolites, commonly found in fruit, legumes, chocolate, coffee, and nuts among other foods that have been shown to improve cardiovascular and metabolic health, as well as reduce inflammation and oxidative stress.
Detailed description
Haskap berries (Lonicera caerulea L.), also known as Blue Honeysuckle or Honeyberry, are a polyphenol rich berry that has a greater polyphenolic content than other commonly consumed berries, like strawberries or blueberries. Haskap berries are unique, having a greater content of polyphenols compared to other foods, specifically cyanidin-3-glucoside. Cyanidin-3-glucoside is an anthocyanin shown to reduce inflammation and cardioprotective effects. There is a growing body of literature describing the impact of berry consumption on metabolic health; however, Haskap berry specific investigations in human participants are limited. Currently, Haskap berry consumption shows promising findings in research related to glycemic control, oxidative stress, and inflammation in in-vitro and mice models. The benefits of Haskap berries as a functional food are highly encouraging in animal models, but translational research to demonstrate beneficial health impacts in humans is needed.
A crucial aspect of polyphenol metabolism is the role of the gut microbiome, which influences both metabolic responses to polyphenol consumption and the bioavailability of polyphenolic metabolites. Polyphenol digestion differs based on the structure of the polyphenol and what area of digestive tract is being considered. In the mouth, mastication and salivary enzymes begin the digestion process. However, polyphenols bind with salivary proteins, like tannin-binding salivary proteins, that inhibit their breakdown and subsequent absorption. In the stomach, a limited amount of polyphenols are broken down and/or absorbed and other are conjugated with glucuronic acid. In the small intestine, polyphenols are hydrolyzed into smaller subunits to be absorbed by both passive and active transport. Lastly, the large intestine is the most important segment of digestion to consider.
One of the challenges of polyphenolic research is the intricate relationship between the gut microbiota and the absorption of polyphenolic compounds. Bacteria in the gut are responsible for the majority of polyphenol digestion. Bacteria in the gut interact with polyphenols in a variety of biotransformation reactions including esterification, dehydroxylation, reduction, and decarboxylation. Certain bacteria in the gut have the ability to perform these reactions with polyphenols, including but not limited to Flavonifractor plautii and Bifidobacterium spp. Polyphenol consumption has been shown to modulate microbial composition; however, this project aims to understand how the microbiome impacts metabolite abundance.
This project aims to bridge an important gap that is how the gut microbiome impacts dietary polyphenol absorption and metabolism and how this impacts the health-promoting compounds in Haskap berries. The purpose of this research proposal is to investigate how the microbiome impacts metabolism of polyphenols from Haskap berries. Overarching hypothesis: The composition of bacteria in the gut of participants will impact the Haskap-related metabolites produced
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haskap | Experimental | Dietary Supplement: HaskapHaskap puree will be consumed by all participants after a fasting blood sample is collected |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-45 years old
- Body mass index (BMI) between 18-30 kg/m^2
Key exclusion criteria (9 listed)
- allergy to Haskap berries
- have taken antibiotics in the last 90 days
- take dietary supplements
- have adverse events from blood draws
- take medication to lower cholesterol, inflammation, lipids
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 |
|---|---|---|
| HaskapA whole, frozen Haskap berry puree blended with water in a 2:1 ratio of berry to water. | Dietary supplement | Haskap |
Primary outcome
Metabolite Abundance
Time frame: 48 hours
Relative abundance of metabolites and degradation products of Haskap berries
Metabolite Identity
Time frame: 48 hours
Identify metabolites with fragmentation MS/MS data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Microbial Colonization
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Active, not recruiting
Barrier-Protect Study
Infection
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
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.
Mary P Miles, PhD principal investigator
Montana State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haskap in people with Microbial Colonization and Metabolic Disease, run by Montana State University 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 2 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Metabolite Abundance (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2025.