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OpenTrials
Completed

NCT Number: NCT02210234

Wheat Bioactives and Immune Function

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.

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Key information

Conditions

Endocrine, Nutritional, Metabolic and Immunity Disorders Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food Science & Human Nutrition, University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • generally healthy
  • aged 18-65

Exclusion criteria

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

Treatment and study plan

50 grams of whole wheat bran cereal

Dietary Supplement

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.

Other names: Kellogg's brand whole wheat bran cereal

100 grams of whole wheat bran cereal

Dietary Supplement

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.

Other names: Kellogg's brand whole wheat bran cereal

Primary outcomes

  1. γδ-T cell proliferation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Kellogg's Corporate Citizens Fund

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2014
Registry last updated
Aug 6, 2014

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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