Wheat Bioactives and Immune Function

Not Applicable

Completed

• Conditions: Endocrine, Nutritional, Metabolic and Immunity Disorders
• Interventions: Dietary Supplement: 50 grams of whole wheat bran cereal; Dietary Supplement: 100 grams of whole wheat bran cereal

• Registration Number: NCT02210234
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2014-08
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-05
• Last Update Submitted: 2014-08-05
• Study First Posted: 2014-08-06
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• generally healthy
• aged 18-65

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 grams of whole wheat bran cereal	50 grams of whole wheat bran cereal	This arm was randomized to eat 50 grams of whole wheat brand cereal during the day for 3 weeks.
100 grams of whole wheat bran cereal	100 grams of whole wheat bran cereal	This arm was randomized to eat 100 grams of whole wheat brand cereal the day for 3 weeks.

Primary Outcome Measures

Name	Time	Method
γδ-T cell proliferation	Change in Baseline and 3 weeks	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).

Trial Locations

Locations (1)

Department of Food Science & Human Nutrition, University of Florida; 🇺🇸 Gainesville, Florida, United States