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| Name | Class |
|---|---|
| Arizona State University | OTHER |
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We propose to study the role of the gut microbiome in the development of obesity, and whether we can change the microbiome's contribution to host energy balance through diet. We have created a novel model that explicitly links the effects of microorganisms on human energy balance and modeled weight change, and will use the power of metabolic ward studies to measure small changes in energy absorption, total daily energy expenditure, and/or food intake that affect long-term weight gain or loss. By integrating clinical measurements, bioreactor experiments, and mathematical modeling, we will be able to describe cause-and-effect mechanisms that will enable a quantification of the microbiota's contribution to weight gain and inspire future studies on the interactions of diet, the gut microbiome, and human physiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Western diet | Active Comparator | Participants will consume a control western diet prepared by our metabolic research kitchen for an outpatient period followed by an inpatient period. |
|
| Microbiome Enhancer diet | Experimental | Participants will consume an experimental microbiome enhancer diet prepared by our metabolic research kitchen for an outpatient period followed by an inpatient period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | Participants will consume either a Control Western Diet or a Microbiome Enhancer Diet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint for the protocol is the within-participant difference in fecal energy (via chemical oxygen demand, COD) normalized to the total daily energy intake and to the non-metabolizable marker PEG [COD (kcal) / PEG (g)]. | Comparison within subject of control diet versus microbiome enhancer diet. | Days 24-29 vs. Days 53-58 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Smith, MD | Study Principal Investigator | Principal Investigator |
| Rosa Krajmalnik-Brown, PhD | Study Principal Investigator at Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Research Institute for Metabolism and Diabetes | Orlando | Florida | 32804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40835099 | Derived | Igudesman D, Yu G, Dutta T, Carnero EA, Krajmalnik-Brown R, Smith SR, Corbin KD. Global Metabolite Profiling in Feces, Serum, and Urine Yields Insights into Energy Balance Phenotypes Induced by Diet-Driven Microbiome Remodeling. Am J Clin Nutr. 2025 Oct;122(4):1027-1041. doi: 10.1016/j.ajcnut.2025.08.003. Epub 2025 Aug 19. | |
| 37258525 |
| Label | URL |
|---|---|
| Translational Research Institute for Metabolism and Diabetes | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2019 | May 28, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Corbin KD, Carnero EA, Dirks B, Igudesman D, Yi F, Marcus A, Davis TL, Pratley RE, Rittmann BE, Krajmalnik-Brown R, Smith SR. Host-diet-gut microbiome interactions influence human energy balance: a randomized clinical trial. Nat Commun. 2023 May 31;14(1):3161. doi: 10.1038/s41467-023-38778-x. |
| 32875141 | Derived | Corbin KD, Krajmalnik-Brown R, Carnero EA, Bock C, Emerson R, Rittmann BE, Marcus AK, Davis T, Dirks B, Ilhan ZE, Champagne C, Smith SR. Integrative and quantitative bioenergetics: Design of a study to assess the impact of the gut microbiome on host energy balance. Contemp Clin Trials Commun. 2020 Aug 19;19:100646. doi: 10.1016/j.conctc.2020.100646. eCollection 2020 Sep. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |