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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK114504-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The overarching goal of this project is to determine whether the effect of gut microbiota on human metabolism might be mediated by short chain fatty acids (SCFA) and whether the SCFA might modulate lipid metabolism.
This would be the first study determining the effect of SCFA synthesis on hepatic de novo lipogenesis and to assess whether and how isocaloric dietary changes (namely low carbohydrates) might modify the composition of the gut microbiota and reduce the synthesis of SCFA during adolescence, a sensitive period for the development of obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obese carbohydrate diet | Experimental | Obese adolescents with a body mass index (BMI) >95th percentile. |
|
| lean carbohydrate diet | Active Comparator | Lean adolescents with a body mass index (BMI) <85th percentile. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| obese carbohydrate diet | Dietary Supplement | The experimental diet will consist of 30% carbohydrates (CHO), 35% protein, and 35% fat. Since the experimental diet is lower in CHO, the fiber and sugar content will be calculated based on total CHO in the same percentage as the control (0.25 g fiber per each kcal of CHO and 18.2% sugar for total CHO). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Appearance of Acetate | Starting at 08:00, we began a 10-h, primed, continuous, peripheral venous infusion of 99% sodium [d3]-acetate with a priming dose of 200 μg · kg-1 · min-1 for 4 min and a continuous infusion rate of 59.5 μg · kg-1 · min-1 for 10 h. After 180 min from the start of the infusion, subjects received 20 g of lactulose per os, dissolved in 30 mL of water. | Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours) |
| Percent of Hepatic de Novo Lipogenesis. | The percent of hepatic de novo lipogenesis (DNL) refers to the proportion of fatty acids in the liver that are derived from a de novo synthesis pathway, rather than from dietary sources. | Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours) |
| Change in the Rate of Appearance of Acetate | The changes in rate of appearance of acetate (RaAcetate) are measured averaging the basal RaAcetate 9 timepoints (2 and 3 hours) and the post-lactulose RaAcetate (timepoints 7, 8, 9 and 10 hours). | Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Santoro, Phd,MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Research Unit | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37159195 | Derived | Galuppo B, Umano GR, Li Z, Van Name M, Samuels SL, Kien CL, Cline GW, Wagner DA, Barbieri E, Trico D, Santoro N. Comparison of Metabolic Response to Colonic Fermentation in Lean Youth vs Youth With Obesity. JAMA Netw Open. 2023 May 1;6(5):e2312530. doi: 10.1001/jamanetworkopen.2023.12530. | |
| 34494088 | Derived | Galuppo B, Cline G, Van Name M, Shabanova V, Wagner D, Kien CL, Santoro N. Colonic Fermentation and Acetate Production in Youth with and without Obesity. J Nutr. 2021 Nov 2;151(11):3292-3298. doi: 10.1093/jn/nxab277. |
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Children and adolescents between 15 and 25 years of age.
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| ID | Title | Description |
|---|---|---|
| FG000 | Youth With Obesity | Obese adolescents with a body mass index (BMI) >95th percentile. |
| FG001 | Lean Youth | Lean adolescents with a body mass index (BMI) <85th percentile. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The overall number of participants included in the baseline analysis population is less than the number of participants assigned to study arms because some participants did not complete baseline assessments or had missing baseline data
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| ID | Title | Description |
|---|---|---|
| BG000 | Youth With Obesity | Obese adolescents with a body mass index (BMI) >95th percentile. |
| BG001 | Lean Youth | Lean adolescents with a body mass index (BMI) <85th percentile. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Appearance of Acetate | Starting at 08:00, we began a 10-h, primed, continuous, peripheral venous infusion of 99% sodium [d3]-acetate with a priming dose of 200 μg · kg-1 · min-1 for 4 min and a continuous infusion rate of 59.5 μg · kg-1 · min-1 for 10 h. After 180 min from the start of the infusion, subjects received 20 g of lactulose per os, dissolved in 30 mL of water. | Posted | Mean | Standard Error | umol/kg/min | Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours) |
|
10 HOURS
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Youth With Obesity or Overweight | Youth with a BMI percentile above 85th | 0 |
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The study included a relatively small cohort of participants, which may limit the statistical power and generalizability of the findings. Differences in gut microbiota composition were not evaluated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicola Santoro | Yale University School of Medicine: Pediatrics Endocrinology | 2037376356 | nicola.santoro@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2023 | Jun 26, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2023 | Jun 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| lean carbohydrate diet | Dietary Supplement | The control diet composition will follow the American Dietary Guidelines of 55% carbohydrates (CHO), 15% protein, and 30% fat. CHO content will be primarily complex CHO of high quality (14 g fiber/1,000 kcals and <10% of total kcals in the form of sugar). |
|
| 32561908 | Derived | Monga Kravetz A, Testerman T, Galuppo B, Graf J, Pierpont B, Siebel S, Feinn R, Santoro N. Effect of Gut Microbiota and PNPLA3 rs738409 Variant on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Youth. J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3575-85. doi: 10.1210/clinem/dgaa382. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Rate of appearance of acetate | Mean | Standard Deviation | μmol · kg-1 · min-1 |
|
|
|
| Primary | Percent of Hepatic de Novo Lipogenesis. | The percent of hepatic de novo lipogenesis (DNL) refers to the proportion of fatty acids in the liver that are derived from a de novo synthesis pathway, rather than from dietary sources. | Posted | Mean | Standard Error | Percentage | Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours) |
|
|
|
| Primary | Change in the Rate of Appearance of Acetate | The changes in rate of appearance of acetate (RaAcetate) are measured averaging the basal RaAcetate 9 timepoints (2 and 3 hours) and the post-lactulose RaAcetate (timepoints 7, 8, 9 and 10 hours). | Posted | Mean | Standard Deviation | micromol/Kg/minute | Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours) |
|
|
|
|
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Youth Without Obesity | Youth with a BMI percentile below 75th | 0 | 19 | 0 | 19 | 0 | 19 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |