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| ID | Type | Description | Link |
|---|---|---|---|
| 7005865 | Other Grant/Funding Number | USDA NIFA Hatch |
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Dietary fiber has been shown to have beneficial effects on human health through its impact on microbes present in the gut. However, these effects can vary between individuals, and everyone may not reap the same health benefits by eating the same sources of fiber. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes change in response to different sources of fiber would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber. The objective of this study is to evaluate candidate predictors of gut microbiota response to fiber sources from either whole grains or fruits and vegetables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Group A: Whole grains then fruits and vegetables | Experimental | Whole grain intervention then fruits and vegetables |
|
| Experimental: Group B: Fruits and vegetables then whole grains | Experimental | Fruits and vegetables intervention then whole grains |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Grain Intervention then fruits and vegetables | Other | TREATMENT 1: Participants will eat whole grains that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when they eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual. TREATMENT 2: Participants will eat fruits and vegetables that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when participants eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight changes | For each intervention (whole grains & fruits and vegetables), investigators will measure change in body weight in kg = Post-intervention minus Pre-intervention | 3-4 weeks |
| Body fat percentage changes | For each intervention (whole grains & fruits and vegetables), investigators will measure change in fat percentage = Post-intervention minus Pre-intervention | 3-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome measured by 16S rRNA gene sequencing | For each intervention (whole grains & fruits and vegetables), investigators will calculate changes in relative abundance (proportion) of each gut bacterium from Pre-intervention to Post-intervention. | 3-4 weeks |
| Fecal short-chain fatty acid concentrations (SCFAs) |
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Inclusion Criteria:
Exclusion Criteria:
Electronic medical implant, for example, a pacemaker.
An existing, UNTREATED, thyroid condition.
Use of systemic antibiotics (intravenous injection, intramuscular, or oral) within the last 4 months.
An acute disease at the time of enrollment (Acute disease is defined as the presence of a moderate or severe illness with or without fever).
A chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality.
Any suspected state of immunosuppression or immunodeficiency including HIV.
A history of active UNTREATED gastrointestinal disorders or diseases including
Previously had bariatric surgery.
An unstable dietary history as defined by major changes in diet during the previous month. For example, elimination or significantly increased intake of a major food group in the diet.
Recent history of chronic alcohol consumption defined as more than 5 drinks (or servings) of alcohol per day.
Female participants: pregnant/lactating.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Poole | Contact | 607-255-8796 | pnnystudy@cornell.edu | |
| Colette Strathman | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornell University | Recruiting | Ithaca | New York | 14850 | United States |
We will NEVER share de-identified data about the participants. Our previous publications show aggregated data results. This study is identical to our previous in design, sample types, and data being collected. We shared the de-identified 16S rRNA sequence data of the participants in a public database as requested by the journals. When requested by a journal, we have shared eligibility criteria. Some journals may require us to share our statistical code.
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| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014675 | Vegetables |
| D005638 | Fruit |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Participants will be randomly assigned to one of two parallel arms in the intervention study. During each of the arms (pre and end time points), investigators will collect fecal samples and weigh the participants and measure body composition.
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| Fruit and Vegetable Intervention and then whole grains | Other | TREATMENT 1: Participants will eat fruits and vegetables that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when participants eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual. TREATMENT 2: Participants will eat whole grains that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when they eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual. |
|
For each intervention (whole grains & fruits and vegetables), investigators will measure change in SCFA concentrations = Post-intervention minus Pre-intervention. We will report the SCFAs acetate, butyrate, and propionate. |
| 3-4 weeks |