Fast Food, Fatigue, and Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-13

Study Completion Date

2013-06-11

Brief Summary

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This double-blind, randomized crossover trial assessed inflammation and fatigue following a fast-food-type meal (saturated fat) compared to a healthier meal (monounsaturated fat) in breast cancer survivors and benign controls (women who had an initial abnormal test for breast cancer).

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized crossover trial: participants were randomized to sequence of meal type; they ate one high saturated fat meal and one high oleic sunflower oil meal with 1-4 weeks washout in between meals

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind: The data manager assigned arbitrary names to each meal so that only the data manager and the kitchen staff were unblinded.

Study Groups

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Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal)

Group Type EXPERIMENTAL

Saturated Fat Meal

Intervention Type OTHER

Oleic Sunflower Oil Meal

Intervention Type OTHER

Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal)

Group Type ACTIVE_COMPARATOR

Saturated Fat Meal

Intervention Type OTHER

Oleic Sunflower Oil Meal

Intervention Type OTHER

Interventions

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Saturated Fat Meal

Intervention Type OTHER

Oleic Sunflower Oil Meal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* We recruited a subset of a larger parent longitudinal observational study to participate in this study. Initially, participants were recruited following an abnormal mammogram, which resulted in either a malignant (cancer group) or benign (non-cancer control group) diagnosis.

Exclusion Criteria

* A history of any prior cancer except basal or squamous cell, chronic obstructive pulmonary disease, evidence of liver or kidney failure, symptomatic ischemic heart disease, significant visual or auditory problems, cognitive impairment, major medical conditions involving the immune system such as diabetes, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, alcohol or drug abuse, marked and recurrent gastrointestinal problems, or regular use of medications with major immunological consequences, e.g., steroids.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No