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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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This study will test the effect of diet on asthma in individuals with obesity.
This is a crossover design pilot trial that will recruit 12 adults with obesity and 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Function | FEV1 (forced expiratory volume in 1 second; % of predicted) | Baseline |
| Lung Function | FEV1 (forced expiratory volume in 1 second; % of predicted) |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Baton Rouge | Louisiana | 70808 | United States |
Study data will be provided upon request and approval by study PI.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| 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. |
|
| 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 | FEV1 (forced expiratory volume in 1 second; % of predicted) | 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |