Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals

Obesity Clinical Trial

Official title:

Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals Through Intake of Whole Wheat Products in Comparison With Fruits and Vegetables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602496
• Other study ID #: UNebraskaLincolnFDST1
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 2017

Study information

• Verified date: May 2019
• Source: University of Nebraska Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Obesity
• Overweight

Intervention

Other:
• Fruits and Vegetables
5 servings of fruits or vegetables
• Whole Grain
3 servings of whole grain
• Control
3 servings of refined grain

Locations

Country	Name	City	State
United States	Food Innovation Center	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska Lincoln

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
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.	8 weeks
Primary	Change in Tumor Necrosis Factor-a (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-a 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
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.	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.	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.	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.	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.	8 weeks