Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals

NCT02602496 | Completed Results DMC

• 1 other identifier: UNebraskaLincolnFDST1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Overweight

Keywords

Diet; Whole grain; Fruits; Vegetables; Gut health; Anti-inflammatory

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0)

  8 weeks

• Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)

  8 weeks

• Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)

  8 weeks

Other Outcomes (1)

• Change in Body Mass Index (Value at Week 8 Minus Value at Week 0)

  8 weeks

Study Arms (3)

Control

EXPERIMENTAL

3 servings of refined grains per day.

Other: Control

Fruits and Vegetables

EXPERIMENTAL

5 servings of fruits and vegetable per day.

Other: Fruits and Vegetables

Whole Grain

EXPERIMENTAL

3 servings of whole grains per day.

Other: Whole Grain

Interventions

Fruits and Vegetables OTHER

5 servings of fruits or vegetables

Fruits and Vegetables

Whole Grain OTHER

3 servings of whole grain

Whole Grain

Control OTHER

3 servings of refined grain

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Men and women with fruits and vegetable intake exceeding 2 servings/day
• Men and women with whole grain intakes exceeding 1 serving/day
• Pregnant

Sponsors & Collaborators

• University of Nebraska Lincoln: lead

Study Sites (1)

Food Innovation Center

Lincoln, Nebraska, 68588, United States

Location

Related Publications (1)

• 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.

  PMID: 30060746 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Fruit; Vegetables; Whole Grains

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Edible Grain; Crops, Agricultural; Seeds

Results Point of Contact

• Title: Dr. Devin Rose
• Organization: University of Nebraska Lincoln

drose3@unl.edu

402-472-2802

Study Officials

• Devin J Rose, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 11, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 5, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-05

Locations

US (1)