Wheat Bioactives and Immune Function

Endocrine, Nutritional, Metabolic and Immunity Disorders Clinical Trial

Official title:

Wheat Bioactives and Immune Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210234
• Other study ID #: 114-2010
• Status: Completed
• Phase: N/A
• First received: August 5, 2014
• Last updated: August 5, 2014
• Start date: May 2010
• Est. completion date: June 2010

Study information

• Verified date: August 2014
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• generally healthy

• aged 18-65

Exclusion Criteria:

• chronic health problems

• high blood pressure

• BMI greater than 25

• vegan

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endocrine, Nutritional, Metabolic and Immunity Disorders
• Immune System Diseases

Intervention

Dietary Supplement:
• 50 grams of whole wheat bran cereal
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.
• 100 grams of whole wheat bran cereal
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.

Locations

Country	Name	City	State
United States	Department of Food Science & Human Nutrition, University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Kelloggs Corporate Citizens Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?d-T cell proliferation	Flow cytometry is used to compare the percentage of ?d-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).	Change in Baseline and 3 weeks	No