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Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602496
Recruitment Status : Completed
First Posted : November 11, 2015
Results First Posted : May 10, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Devin Rose, University of Nebraska Lincoln

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Obesity Overweight Other: Fruits and Vegetables Other: Whole Grain Other: Control Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals Through Intake of Whole Wheat Products in Comparison With Fruits and Vegetables
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: Control
3 servings of refined grains per day.
Other: Control
3 servings of refined grain

Experimental: Fruits and Vegetables
5 servings of fruits and vegetable per day.
Other: Fruits and Vegetables
5 servings of fruits or vegetables

Experimental: Whole Grain
3 servings of whole grains per day.
Other: Whole Grain
3 servings of whole grain




Primary Outcome Measures :
  1. Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0) [ Time Frame: 8 weeks ]
    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.

  2. Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0) [ Time Frame: 8 weeks ]
    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.

  3. Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0) [ Time Frame: 8 weeks ]
    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.

  4. Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0) [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0) [ Time Frame: 8 weeks ]
    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.

  2. Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0) [ Time Frame: 8 weeks ]
    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.

  3. Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0) [ Time Frame: 8 weeks ]
    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.


Other Outcome Measures:
  1. Change in Body Mass Index (Value at Week 8 Minus Value at Week 0) [ Time Frame: 8 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese or overweight men or women (body mass index, BMI, ≥25 kg/m2)
  • Free of known gastrointestinal disease
  • No supplements use (excluding multivitamin)
  • Participate in less than 1 h of exercise per week
  • Have not taken antibiotics in the last six months

Exclusion Criteria:

  • Men and women with fruits and vegetable intake exceeding 2 servings/day
  • Men and women with whole grain intakes exceeding 1 serving/day
  • Pregnant
  • Do not fit the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602496


Locations
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United States, Nebraska
Food Innovation Center
Lincoln, Nebraska, United States, 68588
Sponsors and Collaborators
University of Nebraska Lincoln
Investigators
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Principal Investigator: Devin J Rose, PhD University of Nebraska
  Study Documents (Full-Text)

Documents provided by Devin Rose, University of Nebraska Lincoln:
Statistical Analysis Plan  [PDF] November 27, 2017
Informed Consent Form  [PDF] November 5, 2015
Study Protocol  [PDF] December 23, 2014

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Devin Rose, Associate Professor, University of Nebraska Lincoln
ClinicalTrials.gov Identifier: NCT02602496    
Other Study ID Numbers: UNebraskaLincolnFDST1
First Posted: November 11, 2015    Key Record Dates
Results First Posted: May 10, 2019
Last Update Posted: June 5, 2019
Last Verified: May 2019
Keywords provided by Devin Rose, University of Nebraska Lincoln:
Diet
Whole grain
Fruits
Vegetables
Gut health
Anti-inflammatory
Additional relevant MeSH terms:
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Inflammation
Overweight
Pathologic Processes
Body Weight