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This study evaluates the impact of increased intake of fruits and vegetables and whole grains on markers of inflammation and gut microbial composition. The treatment groups are 3 servings of whole grain per day; 5 servings of fruits and vegetables per day; and a control (3 servings of refined grains per day provided).
Literature data suggests that fruits and vegetables and whole grains containing dietary fiber and other nutrients are important for maintaining beneficial microbes in the gut. The presence of beneficial microbes in the gut may mediate the subclinical inflammation experienced in metabolic disease. In this project, overweight or obese participants with low intakes of fruits and vegetables or whole grains will increase their intake of these foods to recommended levels. Changes in markers of inflammation and gut microbiota composition will be determined to assess and compare the potential impact of these foods on metabolic disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | 3 servings of refined grains per day. |
|
| Fruits and Vegetables | Experimental | 5 servings of fruits and vegetable per day. |
|
| Whole Grain | Experimental | 3 servings of whole grains per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruits and Vegetables | Other | 5 servings of fruits or vegetables |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0) | Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for interleukin-6 concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8. | 8 weeks |
| Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0) | Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for tumor necrosis factor-α concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8. | 8 weeks |
| Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0) | Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for high sensitivity C-reactive protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8. | 8 weeks |
| Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0) | Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for lipopolysaccharide binding protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0) | The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (Value at Week 8 Minus Value at Week 0) | Body mass index will be measured on participants at the beginning (week 0) and end of the study (week 8). Changes in body mass index will be determined. | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devin J Rose, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food Innovation Center | Lincoln | Nebraska | 68588 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30060746 | Derived | Kopf JC, Suhr MJ, Clarke J, Eyun SI, Riethoven JM, Ramer-Tait AE, Rose DJ. Role of whole grains versus fruits and vegetables in reducing subclinical inflammation and promoting gastrointestinal health in individuals affected by overweight and obesity: a randomized controlled trial. Nutr J. 2018 Jul 30;17(1):72. doi: 10.1186/s12937-018-0381-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 3 servings of refined grains per day. Control: 3 servings of refined grain |
| FG001 | Fruits and Vegetables | 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables |
| FG002 | Whole Grain | 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | 3 servings of refined grains per day. Control: 3 servings of refined grain |
| BG001 | Fruits and Vegetables | 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Only subjects that finished the study were included in the overall analysis. |
| 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 | Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0) | Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for interleukin-6 concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8. | IL-6 was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period. | Posted | Mean | Standard Error | pg/mL | 8 weeks |
|
8 Weeks
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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 | Control | 3 servings of refined grains per day. Control: 3 servings of refined grain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Devin Rose | University of Nebraska Lincoln | 402-472-2802 | drose3@unl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 27, 2017 | Feb 6, 2019 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 5, 2015 | Feb 6, 2019 | ICF_002.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 23, 2014 | May 13, 2019 | Prot_003.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D005638 | Fruit |
| D014675 | Vegetables |
| D000067348 | Whole Grains |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Whole Grain |
| Other |
3 servings of whole grain |
|
| Control | Other | 3 servings of refined grain |
|
| Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0) | Short-chain fatty acids (SCFAs) are the end products of fermentation of dietary fibers by the anaerobic intestinal microbiota. SCFAs have been shown to exert multiple beneficial effects on mammalian energy metabolism. | 8 weeks |
| Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0) | Branched chain fatty acids (BCFA) are mostly saturated fatty acids (SFA) with one or more methyl branches on the carbon chain. BCFAs were extracted from stool samples and measured using gas chromatography. | 8 weeks |
| BG002 | Whole Grain | 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Only subjects that finished the study were included in the analysis | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Only subjects that finished the study were included in the analysis | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Interleukin-6 | Only subjects that finished the study were included in the analysis | Mean | Standard Deviation | pg/mL |
|
| high sensitivity C-reactive protein | Only subjects that finished the study were included in the analysis | Mean | Standard Deviation | mg/mL |
|
| TNF-alpha | Only subjects that finished the study were included in the analysis | Mean | Standard Deviation | pg/mL |
|
| lipopolysaccharide binding protein | Only subjects that finished the study were included in the analysis | Mean | Standard Deviation | mg/L |
|
5 servings of fruits and vegetable per day.
Fruits and Vegetables: 5 servings of fruits or vegetables
| OG002 | Whole Grain | 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain |
|
|
|
| Primary | Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0) | Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for tumor necrosis factor-α concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8. | TNF-α was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period. | Posted | Mean | Standard Error | pg/mL | 8 weeks |
|
|
|
|
| Primary | Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0) | Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for high sensitivity C-reactive protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8. | C-reactive protein was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period. | Posted | Mean | Standard Error | mg/mL | 8 weeks |
|
|
|
|
| Primary | Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0) | Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for lipopolysaccharide binding protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8. | Lipopolysaccharide binding protein was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period. | Posted | Mean | Standard Error | mcg/mL | 8 weeks |
|
|
|
|
| Secondary | Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0) | The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity. | Alpha diversity was analyzed through the Shannon's Index. The mean outcome is the mean difference between the end and beginning of the treatment period. | Posted | Mean | Standard Error | Shannon's Index | 8 weeks |
|
|
|
|
| Secondary | Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0) | Short-chain fatty acids (SCFAs) are the end products of fermentation of dietary fibers by the anaerobic intestinal microbiota. SCFAs have been shown to exert multiple beneficial effects on mammalian energy metabolism. | Mean outcome is the mean difference between the beginning and end of the study. SCFAs were extracted from stool samples and measured using gas chromatography. | Posted | Mean | Standard Error | mmol/g | 8 weeks |
|
|
|
|
| Secondary | Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0) | Branched chain fatty acids (BCFA) are mostly saturated fatty acids (SFA) with one or more methyl branches on the carbon chain. BCFAs were extracted from stool samples and measured using gas chromatography. | The outcome mean is the mean difference between the beginning and the end of the study. | Posted | Mean | Standard Error | mmol/g | 8 weeks |
|
|
|
|
| Other Pre-specified | Change in Body Mass Index (Value at Week 8 Minus Value at Week 0) | Body mass index will be measured on participants at the beginning (week 0) and end of the study (week 8). Changes in body mass index will be determined. | Weight and height were measured to calculate the BMI. The outcome mean is the mean difference between the beginning and end of the treatment period. | Posted | Mean | Standard Error | kg/m^2 | 8 weeks |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Fruits and Vegetables | 5 servings of fruits and vegetable per day. Fruits and Vegetables: 5 servings of fruits or vegetables | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Whole Grain | 3 servings of whole grains per day. Whole Grain: 3 servings of whole grain | 0 | 17 | 0 | 17 | 0 | 17 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002523 |
| Edible Grain |
| D018556 | Crops, Agricultural |
| D012639 | Seeds |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
Corrected for baseline concentrations, age, gender, and body mass index
| 0.2276 |
| Equivalence |
Value at week 8 minus value at week 0 |
| ANOVA | Corrected for baseline concentrations, age, gender, and body mass index | 0.0006 | Equivalence | Value at week 8 minus value at week 0 |
Corrected for baseline concentrations, age, gender, and body mass index
| 0.1642 |
| Equivalence |
Value at week 8 minus value at week 0 |
| ANOVA | Corrected for baseline concentrations, age, gender, and body mass index | 0.6043 | Equivalence | Value at week 8 minus value at week 0 |
Corrected for baseline concentrations, age, gender, and body mass index
| 0.0083 |
| Equivalence |
Value at week 8 minus value at week 0 |
| ANOVA | Corrected for baseline concentrations, age, gender, and body mass index | 0.0151 | Equivalence | Value at week 8 minus value at week 0 |
Corrected for baseline concentrations, age, gender, and body mass index
| 0.0454 |
| Equivalence |
Value at week 8 minus value at week 0 |
| ANOVA | Corrected for baseline concentrations, age, gender, and body mass index | 0.2920 | Equivalence | Value at week 8 minus value at week 0 |
Corrected for baseline concentrations, age, gender, and body mass index
| 0.4715 |
| Equivalence |
Value at week 8 minus value at week 0 |
| ANOVA | Corrected for baseline concentrations, age, gender, and body mass index | 0.7157 | Equivalence | Value at week 8 minus value at week 0 |
Corrected for baseline concentrations, age, gender, and body mass index
| 0.8927 |
| Equivalence |
Value at week 8 minus value at week 0 |
| ANOVA | Corrected for baseline concentrations, age, gender, and body mass index | 0.3173 | Equivalence | Value at week 8 minus value at week 0 |