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Completed

NCT Number: NCT02602496

Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals

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).

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food Innovation Center

Lincoln, Nebraska, 68588, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruits and Vegetables

Other

5 servings of fruits or vegetables

Whole Grain

Other

3 servings of whole grain

Control

Other

3 servings of refined grain

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Nebraska Lincoln

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2015
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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