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Cheese Consumption for Inflammation

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Waitlist Available

Led By J. Bruce German, PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-65 years

Two or more components of metabolic syndrome: Central obesity, fasting blood triglycerides, plasma HDL cholesterol, blood pressure, fasting glucose, or BMI equal to or greater than 30

Must not have

Cancer

Gastrointestinal disorders including Crohn's Disease, colitis, diverticulitis, irritable bowel disease, celiac, malabsorption syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 1, 3, 6 hr postprandial

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether cheese or a cheese substitute impacts inflammation over six hours.

Who is the study for?

This trial is for adults aged 18-65 with metabolic syndrome, characterized by conditions like central obesity or high blood pressure. Participants should not have eating disorders, immune diseases, severe allergies to study foods, diabetes, recent changes in exercise or diet habits, a BMI over 40 or weight over 400 lbs., and must not be planning pregnancy.

What is being tested?

The study compares the effects of consuming cheddar cheese versus vegan cheese on inflammation in individuals with metabolic syndrome. Over six hours, researchers will monitor how these two types of cheese influence inflammatory responses.

What are the potential side effects?

Potential side effects are not specified but may include digestive discomfort due to lactose intolerance for those sensitive to dairy products. Vegan cheese could also cause issues if participants have unknown allergies to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have at least two symptoms of metabolic syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer.

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I have a gastrointestinal disorder such as Crohn's, colitis, or celiac disease.

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I use anti-inflammatory pain medication every day.

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I do not have major liver or kidney diseases.

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I have an immune-related condition like autoimmune disease or asthma.

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I have lost or gained more than 10% of my weight in the last 6 months.

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I have Type II diabetes.

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I have not used corticosteroid medications in the last 12 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 1, 3, 6 hr postprandial

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 1, 3, 6 hr postprandial

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 1, 3, 6 hr postprandial for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inflammation

Secondary study objectives

Plasma bone markers

Plasma glucose

Plasma lipid profile

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CheeseExperimental Treatment1 Intervention

Cheese sandwich plus supplemental beverage will deliver 40% of each participants' energy expenditure and will be made up of 50% of energy as fat, 35% of energy as carbohydrate and 15% of energy as protein. The sandwich will contain medium cheddar cheese and whole wheat bread. The supplemental beverage will contain fruit sorbet, glucose polymer, protein powder, high oleic sunflower oil, high polyunsaturated fatty acids (PUFA) sunflower oil, and canola oil.

Group II: Vegan cheeseActive Control1 Intervention

Non-dairy cheese alternative sandwich plus supplemental beverage will deliver 40% of each participants' energy expenditure and will be made up of 50% of energy as fat, 35% of energy as carbohydrate and 15% of energy as protein. The sandwich will contain vegan cheese and whole wheat bread. The supplemental beverage will contain fruit sorbet, glucose polymer, protein powder, cream of tartar, high oleic sunflower oil, high PUFA sunflower oil, and palm oil.

0 / 10Eligibility criteria met