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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01HL169491-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Determine to what extent three distinct dietary approaches improve asthma control and lung function.
This is a crossover design pilot trial that will recruit 15 adults with asthma. Participants will undergo screening and a lead-in period before being randomized to a series of three, 7-day diets with a 7+ day washout period between each diet. Asthma control and lung function will be assessed at the completion of each diet.
The goal of this pilot trial is to understand the effect of diet on asthma and conduct an exploratory analysis on factors that may predict the response to diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Guidelines for Americans | Experimental | 7 days of a diet consistent with the Dietary Guidelines for Americans (DGA). |
|
| Medium Chain Triglyceride Supplemented DGA | Experimental | 7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT). |
|
| Ketogenic Diet | Experimental | 7 days of a ketogenic diet (KETO). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DGA Diet | Other | A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including:
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control | Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5. | Baseline |
| Asthma Control | Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5. | After 7 days on Diet#1 |
| Asthma Control | Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5. | After 7 days on Diet#2 |
| Asthma Control | Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5. | After 7 days on Diet#3 |
| Lung Function | FEV1 (forced expiratory volume in 1 second; % of predicted) | Baseline |
| Lung Function | FEV1 (forced expiratory volume in 1 second; % of predicted) | After 7 days on Diet#1 |
| Lung Function | FEV1 (forced expiratory volume in 1 second; % of predicted) | After 7 days on Diet#2 |
| Lung Function |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic inflammation | plasma interleukin-6 (IL6) | Baseline |
| Systemic inflammation | plasma interleukin-6 (IL6) | After 7 days on Diet#1 |
| Measure | Description | Time Frame |
|---|---|---|
| indirect calorimetry | nutrient utilization according to respiratory exchange ratio (0.66 - 1.0) | baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3 |
| ketosis | plasma ß-hydroxybutyrate (mM) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob T Mey, PhD, RD | Contact | 225-763-2644 | jacob.mey@pbrc.edu | |
| John P Kirwan, PhD | Contact | 225-763-2644 | john.kirwan@pbrc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jacob T Mey, PhD, RD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Recruiting | Baton Rouge | Louisiana | 70808 | United States |
IPD is stored according to our institutional policy. External investigators may request additional data access, which will be shared according to institutional policy with appropriate data sharing agreements.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Participants will not be made aware of the diet allocation. However, due inherent differences in macronutrient content of the diets, participants may perceive differences in the quantity of various food groups or in the taste, texture or smell of foods present in the diet. To address this, diets will be designed to minimize noticeable differences for the participant. The investigator and outcomes assessor will remain fully masked to diet provision.
|
| MCT Diet | Other | A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT). |
|
| KETO Diet | Other | A fully provisioned isocaloric, isonitrogenous ketogenic study diet. |
|
FEV1 (forced expiratory volume in 1 second; % of predicted)
| After 7 days on Diet#3 |
| Systemic inflammation | plasma interleukin-6 (IL6) | After 7 days on Diet#2 |
| Systemic inflammation | plasma interleukin-6 (IL6) | After 7 days on Diet#3 |
| FENO | FENO (ppm) | Baseline |
| FENO | FENO (ppm) | After 7 days on Diet#1 |
| FENO | FENO (ppm) | After 7 days on Diet#2 |
| FENO | FENO (ppm) | After 7 days on Diet#3 |
| FEV1/FVC | FEV1/Forced Vital Capacity (FVC) ratio | Baseline |
| FEV1/FVC | FEV1/Forced Vital Capacity (FVC) ratio | After 7 days on Diet#1 |
| FEV1/FVC | FEV1/Forced Vital Capacity (FVC) ratio | After 7 days on Diet#2 |
| FEV1/FVC | FEV1/Forced Vital Capacity (FVC) ratio | After 7 days on Diet#3 |
| baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3 |
| eosinophilic asthma characterization | absolute blood eosinophils (count) | baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3 |
| immunoglobulin asthma characterization | blood immunoglobulin E (IgE) | baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3 |
| systemic inflammation | blood cytokines (IL17, TNFα, IL1ß) | baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |