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Wheat Bioactives and Immune Function

Primary Purpose

Endocrine, Nutritional, Metabolic and Immunity Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
50 grams of whole wheat bran cereal
100 grams of whole wheat bran cereal
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endocrine, Nutritional, Metabolic and Immunity Disorders focused on measuring wheat bran, healthy immunity, T cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • generally healthy
  • aged 18-65

Exclusion Criteria:

  • chronic health problems
  • high blood pressure
  • BMI greater than 25
  • vegan

Sites / Locations

  • Department of Food Science & Human Nutrition, University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

50 grams of whole wheat bran cereal

100 grams of whole wheat bran cereal

Arm Description

This arm was randomized to eat 50 grams of whole wheat brand cereal during the day for 3 weeks.

This arm was randomized to eat 100 grams of whole wheat brand cereal the day for 3 weeks.

Outcomes

Primary Outcome Measures

γδ-T cell proliferation
Flow cytometry is used to compare the percentage of γδ-T cells in the total CD3 cell population in the blood of subjects before and after three weeks of consuming whole wheat bran cereal. An increase in that percentage would be suggestive of improved immunity (priming).

Secondary Outcome Measures

Full Information

First Posted
August 5, 2014
Last Updated
August 5, 2014
Sponsor
University of Florida
Collaborators
Kellogg's Corporate Citizens Fund
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1. Study Identification

Unique Protocol Identification Number
NCT02210234
Brief Title
Wheat Bioactives and Immune Function
Official Title
Wheat Bioactives and Immune Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Kellogg's Corporate Citizens Fund

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research was to understand the effects of bioactive compounds found in wheat cereal on human immunity. Subjects came in for a baseline blood draw, consumed whole wheat bran cereal daily for 21 days, and returned for a final blood draw. Immune function assays were performed at both sampling times. It was predicted that eating wheat bran would benefit immune function.
Detailed Description
Healthy individuals, between 18 and 50 years of age, were recruited by flyer and word of mouth on the University of Florida campus and in the surrounding area, in May of 2010. Eligible subjects were randomly assigned to one of two experimental groups, to consume either 50 grams or 100 grams of whole wheat bran cereal daily, for three weeks. Blood was drawn from fasting subjects before consumption (baseline) and after three weeks of cereal consumption. Peripheral blood mononuclear cells (PBMC) were isolated and cultured with a broad based mitogen and autologous serum for 10 days. PBMC were stained with fluorochrome-conjugated antibodies on Day 0 and Day 10 of culture, at each blood draw. Data was acquired by flow cytometry and analyzed. Overall compliance was assessed using self-reported data and by counting left-over bags of cereal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine, Nutritional, Metabolic and Immunity Disorders
Keywords
wheat bran, healthy immunity, T cells

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 grams of whole wheat bran cereal
Arm Type
Active Comparator
Arm Description
This arm was randomized to eat 50 grams of whole wheat brand cereal during the day for 3 weeks.
Arm Title
100 grams of whole wheat bran cereal
Arm Type
Active Comparator
Arm Description
This arm was randomized to eat 100 grams of whole wheat brand cereal the day for 3 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
50 grams of whole wheat bran cereal
Other Intervention Name(s)
Kellogg's brand whole wheat bran cereal
Intervention Description
This arm was randomized to eat 50 grams of whole wheat cereal during the day for 3 weeks. At baseline and at week 3 a blood sample was taken to determine if there was any alteration to the proliferation of gamma-delta T-cells.
Intervention Type
Dietary Supplement
Intervention Name(s)
100 grams of whole wheat bran cereal
Other Intervention Name(s)
Kellogg's brand whole wheat bran cereal
Intervention Description
This arm was randomized to eat 100 grams of whole wheat cereal during the day for 3 weeks. At baseline and at week 3 a blood sample was taken to determine if there was any alteration to the proliferation of gamma-delta T-cells.
Primary Outcome Measure Information:
Title
γδ-T cell proliferation
Description
Flow cytometry is used to compare the percentage of γδ-T cells in the total CD3 cell population in the blood of subjects before and after three weeks of consuming whole wheat bran cereal. An increase in that percentage would be suggestive of improved immunity (priming).
Time Frame
Change in Baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: generally healthy aged 18-65 Exclusion Criteria: chronic health problems high blood pressure BMI greater than 25 vegan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan S Percival, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food Science & Human Nutrition, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

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Wheat Bioactives and Immune Function

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