Wheat Bioactives and Immune Function

University of Florida

Status: Completed

Conditions: Endocrine, Nutritional, Metabolic and Immunity Disorders

Treatments: Dietary Supplement: 100 grams of whole wheat bran cereal; Dietary Supplement: 50 grams of whole wheat bran cereal

Study type: Interventional

Funder types: Other

Identifiers

NCT02210234

114-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• generally healthy
• aged 18-65

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

50 grams of whole wheat bran cereal

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: 50 grams of whole wheat bran cereal

100 grams of whole wheat bran cereal

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: 100 grams of whole wheat bran cereal