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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-67017-41032 | Other Grant/Funding Number | U.S. Department of Agriculture |
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| Name | Class |
|---|---|
| MaineHealth | OTHER |
| University of Hawaii Cancer Research Center | OTHER |
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The goal of this controlled feeding trial is to learn about the metabolism of polyphenols, a common class of compounds found in plant-based foods, by the gut microbiome. It will evaluate how differences in gut bacteria across individuals influence metabolism of polyphenols from foods, which may influence health benefits that people receive from different foods.
This is a randomized, cross-over controlled feeding trial. Thirty healthy adult volunteers will be selected to participate on the basis of urinary screening results measuring a gut bacterial metabolite that is produced following consumption of a soy food: 15 O-desmethylangolensin (ODMA) producers and 15 age and gender-matched ODMA non-producers will be included. Participants will be assigned to consume two diets in random order: an apple catechin diet that provides a controlled amount of catechins in apple juice, and a nutritionally-matched low catechin diet. Both diet phases will last 3 days, with a 10 day washout period in between the two diet phases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apple catechin | Experimental | A 3-day controlled diet |
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| Low catechin | Placebo Comparator | A 3-day controlled diet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention - apple catechin diet | Other | The intervention will provide a catechin-containing apple juice, for consumption alongside a low catechin diet tailored to participants calorie needs for weight maintenance. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean sum catechin metabolites | Mean difference in sum catechin metabolite concentration in response to the intervention, stratified by ODMA producers and non-producers. | Post 3-day intervention vs. post 3-day control |
| Measure | Description | Time Frame |
|---|---|---|
| Mean individual catechin metabolites | Mean differences in individual valerolactone and valeric acid concentrations in response to the intervention, stratified by ODMA producers and non-producers. | Post 3-day intervention vs. post 3-day control |
| Differences in microbiome profiles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Slavin, PhD | University of Maryland, College Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition and Food Science | College Park | Maryland | 20742 | United States |
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During the crossover trial of two diets, participants will receive the same foods during both arms. The intervention and control will be delivered by a beverage containing either the active component or a nutritionally equivalent control beverage with similar flavor. Participants will not be told the order of study arms they receive. Drinks will be labeled with a code by a different researcher than the team interacting with participants. The statistician will not know which code corresponds to which intervention until analysis is complete.
| Dietary intervention - low catechin diet | Other | The intervention will provide a nutritionally-matched beverage without catechins, for consumption alongside a low catechin diet tailored to participants calorie needs for weight maintenance. |
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Differences in microbiome profiles in response to the 3-day intervention. |
| Post 3-day intervention vs. post 3-day control |
| Difference in microbiome diversity | Differences in microbiome diversity in response to the 3-day intervention. | Post 3-day intervention vs. post 3-day control |
| Difference in microbial species abundance | Differences in microbial species abundance in response to the 3-day intervention. | Post 3-day intervention vs. post 3-day control |