Gut HealthNCT05488886
Bioavailability of Aronia Berry Polyphenols
A study testing Whole Aronia Berry Powder Applesauce, Aronia Berry Extract Applesauce and Phospholipid-Polyphenol Applesauce in people with Gut Health and Metabolism, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The objective of this study is to conduct a randomized cross-over dietary intervention among healthy adults to compare the bioavailability and the fecal polyphenol metabolites of intervention foods made with whole aronia berry powder, aronia berry extract, phospholipid-polyphenol (PLP), and a low-polyphenol control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Health, Metabolism, Polyphenols
- What is being tested?
- Whole Aronia Berry Powder Applesauce, Aronia Berry Extract Applesauce and Phospholipid-Polyphenol Applesauce
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 28 Mar 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willing to consume low-anthocyanin diets during the last days of wash-in and wash-out periods
- willing to consume intervention foods during the sampling periods
- willing to provide 24-hour urine and fecal samples during the sampling periods.
Who cannot join
- people who do not consider themselves healthy
- anyone with a self-reported previous diagnosis of a gastrointestinal disease (e.g. inflammatory bowel disease, irritable bowel syndrome)
- undergoing current cancer treatment (i.e., chemotherapy, radiation therapy)
- are pregnant, lactating, or trying to become pregnant
- unwilling to consume study foods, or are allergic to sunflower, food colorants, berry ingredients, or any other component of the study foods.
- taking medication that contraindicates grapefruit juice consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing the Bioavailability and Metabolism of Aronia Berry Polyphenols for Improving Gut Health
The objective of this study is to conduct a randomized cross-over dietary intervention among healthy adults to compare the bioavailability and the fecal polyphenol metabolites of intervention foods made with whole aronia berry powder, aronia berry extract, phospholipid-polyphenol (PLP), and a low-polyphenol control. 10 participants will be enrolled and can expect to be on study for up to 28 days.
Read the detailed description
Inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis are two conditions of IBD that are characterized by chronic inflammation and damage of the gastrointestinal tract. In the United States alone, IBD are estimated to affect as many as 1.6 million people. IBD are associated with high morbidity, decreased quality of life, as well as substantial health care costs. IBD currently have no known cure, and treatment of IBD often requires the use of potent immunosuppressors which may lead to side effects or surgery.
Berries and prevention of chronic inflammation: Anthocyanins and other polyphenols are promising dietary agents to prevent and treat IBD by improving intestinal barrier dysfunction, inhibiting differentiation of pro-inflammatory T cells, reducing production of proinflammatory cytokines, and preventing oxidative stress. While preliminary studies are promising, translational human intervention studies are needed to refine delivery of polyphenol-rich foods and to confirm anti-inflammatory mechanisms.
Berries are rich dietary sources of polyphenols and essential nutrients. Polyphenol intake varies significantly by dietary patterns, but mean intake is estimated ~900 mg/day. Among berries, the polyphenol-dense aronia berry is one of the richest sources of fruit polyphenols.
Challenges associated with aronia berry consumption: In spite of its beneficial nutritional properties, the consumption of large amounts of whole aronia berry is not practical because of significant sorbitol and fiber content, which could lead to gastrointestinal discomfort for some individuals. Particularly, IBD patients often are required to limit fiber and whole fruit intake. The investigator's research group recently developed a novel method to extract polyphenols from fruit juice using food-grade lecithin which overcomes this problem.
The investigators hypothesize the resulting phospholipid-polyphenol (PLP) enriched material can improve the delivery of anthocyanins to the gut relative to a purified extract, and similar to that of whole berry. The aim of this study is to determine the comparative metabolism and bioavailability of aronia berry PLP intervention to extract, whole berry, and control food.
Consumption of Intervention Foods: In the morning of the day of each intervention and sampling period (days 6, 13, 20, and 27 i), participants will be asked to visit the Bolling Laboratory at the Department of Food Science fasted. Participants will then be asked to empty their bladders and then consume one serving of the applesauce (≤200 g). Then, in the next 24 h, participants will be asked to only consume commercially available frozen and shelf-stable low-polyphenol meals and snacks provided by study personnel. Insulated bags will be provided to participants for transport of frozen meals. The low-polyphenol diet and snacks will consist of dairy products, meat, low-phenolic snacks (e.g., banana, potato chips) and starch sources (e.g. white bread, rice, and plain bagels). Water will be available to participants over the time course, and its intake is not restricted.
- Conditions
- Gut Health, Metabolism, Polyphenols
- Being tested
- Whole Aronia Berry Powder Applesauce, Aronia Berry Extract Applesauce, Phospholipid-Polyphenol Applesauce, Low-Polyphenol Control Applesauce
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Aronia Berry Powder ApplesauceDietary supplement
The food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce A will additionally contain whole aronia berry powder (Milne MicroDried, Nampa, ID).
Aronia Berry Extract ApplesauceDietary supplement
The food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce B will additionally contain aronia berry extract (Artemis International, Fort Wayne, IN).
Phospholipid-Polyphenol ApplesauceDietary supplement
The food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce C will additionally contain PLP which will be prepared with commercially-available aronia juice concentrate (Greenwood Associates, Niles, IL) and soy lecithin (Whole Foods, Austin, TX).
Low-Polyphenol Control ApplesauceOther
The food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce D will not contain additional polyphenol-rich ingredients and is thus considered a low-polyphenol control.
| Study group | Role | What they receive |
|---|---|---|
| A: Whole Aronia Berry Powder | Experimental | Not described Receives: Dietary Supplement: Whole Aronia Berry Powder Applesauce |
| B: Aronia Berry Extract | Experimental | Not described Receives: Dietary Supplement: Aronia Berry Extract Applesauce |
| C: Phospholipid-Polyphenol | Experimental | Not described Receives: Dietary Supplement: Phospholipid-Polyphenol Applesauce |
| D: Low-Polyphenol Control | Experimental | Not described Receives: Other: Low-Polyphenol Control Applesauce |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Polyphenol Catabolite Concentration
Targeted analysis of free urinary polyphenol metabolites will be performed by ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS).
Measured: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Urinary Anthocyanin Concentration
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Measured: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Fecal Polyphenol Catabolite Concentration
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Measured: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Fecal Anthocyanin Concentration
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Measured: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Urine Creatinine Content
The urine creatinine content will be measured by a urinary creatinine colorimetric assay kit (Cayman Chemical).
Measured: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start9 Feb 2023
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- The order of intervention foods (A-D) will be randomized for each participant upon study enrollment. Wash-in and wash-out periods are 6 days long, and food consumption and sampling durations are 24 hours.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley Bolling, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488886
- Sponsor's protocol ID
- 2022-0702
- Other IDs
- Protocol Version 07/01/2022, A074000
- Status last verified
- Mar 2023
- First submitted
- 1 Aug 2022
- Last updated
- 31 Mar 2023
- Results posted
- 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 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Bioavailability and Metabolism of Aronia Berry Polyphenols for Improving Gut Health
- ClinicalTrials.gov ID
- NCT05488886
- Acronym / sponsor ID
- 2022-0702
- Conditions
- Gut Health, Metabolism, Polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 5 Aug 2022 (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.
The objective of this study is to conduct a randomized cross-over dietary intervention among healthy adults to compare the bioavailability and the fecal polyphenol metabolites of intervention foods made with whole aronia berry powder, aronia berry extract, phospholipid-polyphenol (PLP), and a low-polyphenol control. 10 participants will be enrolled and can expect to be on study for up to 28 days.
Detailed description
Inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis are two conditions of IBD that are characterized by chronic inflammation and damage of the gastrointestinal tract. In the United States alone, IBD are estimated to affect as many as 1.6 million people. IBD are associated with high morbidity, decreased quality of life, as well as substantial health care costs. IBD currently have no known cure, and treatment of IBD often requires the use of potent immunosuppressors which may lead to side effects or surgery.
Berries and prevention of chronic inflammation: Anthocyanins and other polyphenols are promising dietary agents to prevent and treat IBD by improving intestinal barrier dysfunction, inhibiting differentiation of pro-inflammatory T cells, reducing production of proinflammatory cytokines, and preventing oxidative stress. While preliminary studies are promising, translational human intervention studies are needed to refine delivery of polyphenol-rich foods and to confirm anti-inflammatory mechanisms.
Berries are rich dietary sources of polyphenols and essential nutrients. Polyphenol intake varies significantly by dietary patterns, but mean intake is estimated ~900 mg/day. Among berries, the polyphenol-dense aronia berry is one of the richest sources of fruit polyphenols.
Challenges associated with aronia berry consumption: In spite of its beneficial nutritional properties, the consumption of large amounts of whole aronia berry is not practical because of significant sorbitol and fiber content, which could lead to gastrointestinal discomfort for some individuals. Particularly, IBD patients often are required to limit fiber and whole fruit intake. The investigator's research group recently developed a novel method to extract polyphenols from fruit juice using food-grade lecithin which overcomes this problem.
The investigators hypothesize the resulting phospholipid-polyphenol (PLP) enriched material can improve the delivery of anthocyanins to the gut relative to a purified extract, and similar to that of whole berry. The aim of this study is to determine the comparative metabolism and bioavailability of aronia berry PLP intervention to extract, whole berry, and control food.
Consumption of Intervention Foods: In the morning of the day of each intervention and sampling period (days 6, 13, 20, and 27 i), participants will be asked to visit the Bolling Laboratory at the Department of Food Science fasted. Participants will then be asked to empty their bladders and then consume one serving of the applesauce (≤200 g). Then, in the next 24 h, participants will be asked to only consume commercially available frozen and shelf-stable low-polyphenol meals and snacks provided by study personnel. Insulated bags will be provided to participants for transport of frozen meals. The low-polyphenol diet and snacks will consist of dairy products, meat, low-phenolic snacks (e.g., banana, potato chips) and starch sources (e.g. white bread, rice, and plain bagels). Water will be available to participants over the time course, and its intake is not restricted.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The order of intervention foods (A-D) will be randomized for each participant upon study enrollment. Wash-in and wash-out periods are 6 days long, and food consumption and sampling durations are 24 hours.
| Arm | Type | Receives |
|---|---|---|
| A: Whole Aronia Berry Powder | Experimental | Dietary Supplement: Whole Aronia Berry Powder Applesauce |
| B: Aronia Berry Extract | Experimental | Dietary Supplement: Aronia Berry Extract Applesauce |
| C: Phospholipid-Polyphenol | Experimental | Dietary Supplement: Phospholipid-Polyphenol Applesauce |
| D: Low-Polyphenol Control | Experimental | Other: Low-Polyphenol Control Applesauce |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- willing to consume low-anthocyanin diets during the last days of wash-in and wash-out periods
- willing to consume intervention foods during the sampling periods
- willing to provide 24-hour urine and fecal samples during the sampling periods.
Key exclusion criteria (6 listed)
- people who do not consider themselves healthy
- anyone with a self-reported previous diagnosis of a gastrointestinal disease (e.g. inflammatory bowel disease, irritable bowel syndrome)
- undergoing current cancer treatment (i.e., chemotherapy, radiation therapy)
- are pregnant, lactating, or trying to become pregnant
- unwilling to consume study foods, or are allergic to sunflower, food colorants, berry ingredients, or any other component of the study foods.
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 |
|---|---|---|
| Whole Aronia Berry Powder ApplesauceThe food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce A will additionally contain whole aronia berry powder (Milne MicroDried, Nampa, ID). | Dietary supplement | A: Whole Aronia Berry Powder |
| Aronia Berry Extract ApplesauceThe food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce B will additionally contain aronia berry extract (Artemis International, Fort Wayne, IN). | Dietary supplement | B: Aronia Berry Extract |
| Phospholipid-Polyphenol ApplesauceThe food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce C will additionally contain PLP which will be prepared with commercially-available aronia juice concentrate (Greenwood Associates, Niles, IL) and soy lecithin (Whole Foods, Austin, TX). | Dietary supplement | C: Phospholipid-Polyphenol |
| Low-Polyphenol Control ApplesauceThe food will be designed to be a berry-flavored applesauce. The food will include applesauce, sweeteners, citric acid, natural flavors and food colorants. Applesauce D will not contain additional polyphenol-rich ingredients and is thus considered a low-polyphenol control. | Other | D: Low-Polyphenol Control |
Primary outcome
Urinary Polyphenol Catabolite Concentration
Time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
Targeted analysis of free urinary polyphenol metabolites will be performed by ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS).
Urinary Anthocyanin Concentration
Time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Fecal Polyphenol Catabolite Concentration
Time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Fecal Anthocyanin Concentration
Time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
C18 solid-phase extraction (SPE) clean-up methods will be used to isolate anthocyanins and non-anthocyanin low-molecular weight polyphenol metabolites.
Urine Creatinine Content
Time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)
The urine creatinine content will be measured by a urinary creatinine colorimetric assay kit (Cayman Chemical).
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 31 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Bradley Bolling, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Aronia Berry Powder Applesauce, Aronia Berry Extract Applesauce and Phospholipid-Polyphenol Applesauce in people with Gut Health and Metabolism, run by University of Wisconsin, Madison 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 3 inclusion and 6 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 31 Mar 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. 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?
Urinary Polyphenol Catabolite Concentration (time frame: sampled on day 6, 13, 20, and 27 (participant randomized to different interventions each visit)). The study lists 5 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 31 Mar 2023.