What side effects are associated with this type of intervention?

Common treatments for Metabolic Syndrome include lifestyle modifications such as diet and exercise, and medications like statins, antihypertensives, and glucose-lowering drugs. Statins can cause muscle pain, liver damage, and increased blood sugar levels. Antihypertensives may lead to dizziness, headaches, and fatigue. Glucose-lowering drugs, such as metformin, can cause gastrointestinal issues like nausea and diarrhea. Weight loss strategies, including low-energy diets and weight loss surgeries, can lead to nutritional deficiencies and, in some cases, worsening of conditions like psoriasis. Treatments similar to those studied in the trial, such as dietary interventions with specific fat fractions, may have side effects related to gastrointestinal discomfort and potential allergic reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Metabolic Syndrome, primarily focusing on managing its individual components such as type 2 diabetes, hypertension, and dyslipidemia. Commonly approved drugs include metformin for glucose control, statins for lipid management, and antihypertensives like ACE inhibitors. While specific treatments involving dairy fat fractions rich in milk fat globule membrane are not mentioned, dietary interventions and supplements that reduce inflammation and improve metabolic health are often recommended as part of a comprehensive treatment plan for Metabolic Syndrome.

What other types of research exist?

Promising alternatives include: 1) Omega-3 fatty acids, which have anti-inflammatory properties and can be found in fish oil supplements. 2) The Mediterranean diet, which is rich in anti-inflammatory foods like fruits, vegetables, nuts, and olive oil. 3) Probiotics, which can improve gut health and reduce inflammation. 4) The DASH diet, which focuses on reducing sodium intake and increasing consumption of whole grains, fruits, and vegetables. 5) Plant-based diets, which are high in fiber and antioxidants, contributing to reduced inflammation.

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Dietary Supplement

Dairy Fat for Obesity

N/A

Waitlist Available

Led By Angela M. Zivkovic, 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

Central obesity (waist circumference greater than 40 inches for men and 35 inches for women); fasting blood triglycerides greater than or equal to 150 mg/dL; plasma HDL cholesterol (Less than 40 mg/dL for men and less than 50 mg/dL for women); blood pressure greater than or equal to 130/85 mmHg; fasting glucose greater than or equal to 100 mg/dL

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

Use of over-the-counter anti-obesity agents within the last 12 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from 0 hour up to 6 hours postprandial

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a component of dairy fat called milk fat globule membrane (MFGM) can reduce inflammation after eating high-fat meals. It targets people with metabolic syndrome or obesity, who are more prone to inflammation. The study will compare different shakes to see if adding MFGM makes a difference. Milk fat globule membrane (MFGM) is a component of dairy fat known for its anti-inflammatory properties and potential benefits on cardiometabolic health.

Who is the study for?

Adults aged 18-65 with metabolic syndrome or obesity, defined by specific criteria such as waist size, blood fat levels, and blood pressure. Excluded are pregnant women, heavy drinkers, those on certain medications or with gastrointestinal disorders, extreme obesity (BMI >40), recent significant weight changes or dietary shifts.

What is being tested?

The study is testing how different types of fats affect inflammation in people with metabolic issues after eating a high-fat meal. It compares the effects of dairy fat rich in milk fat globule membrane (MFGM) to palm fat over six hours.

What are the potential side effects?

Since this trial involves consumption of dietary fats rather than medication, side effects may include digestive discomfort or changes in energy levels. However, detailed potential side effects related to consuming these specific fats aren't provided.

Eligibility Criteria

Inclusion Criteria

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

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You have a large waist, high triglycerides, low HDL cholesterol, high blood pressure, or high blood sugar.

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I have at least two symptoms of metabolic syndrome.

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I am between 18 and 65 years old.

Exclusion Criteria

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

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I have been diagnosed with cancer.

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I have not used over-the-counter weight loss drugs in the last 3 months.

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I use anti-inflammatory pain medication every day.

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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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My BMI is over 40.

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I do not have any major liver or kidney diseases.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from 0 hour up to 6 hours postprandial

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from 0 hour up to 6 hours postprandial

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from 0 hour up to 6 hours 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

Plasma inflammatory mediators

Secondary study objectives

Tumor Markers

Plasma glucose

Plasma lipid profile

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Palm fat + MFGMExperimental Treatment1 Intervention

The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain palm fat, frozen fruit, glucose polymer, and BPC50, a dairy fraction rich in milk fat globule membrane proteins and phospholipids. Fifty percent of the shake's fat will be derived from BPC50.

Group II: Dairy fat + MFGMExperimental Treatment1 Intervention

The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain whipping cream, frozen fruit, glucose polymer, and BPC50, a dairy fraction rich in milk fat globule membrane proteins and phospholipids. Fifty percent of the shake's fat will be derived from BPC50.

Group III: Palm fatActive Control1 Intervention

Group IV: Dairy fatActive Control1 Intervention

The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain whipping cream, frozen fruit, glucose polymer, and protein powder.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Metabolic Syndrome include lifestyle modifications such as diet and exercise, medications to manage blood pressure, cholesterol, and blood sugar levels, and specific dietary interventions. The trial studying Dairy Fat Fractions Rich in Milk Fat Globule Membrane focuses on reducing postprandial inflammation, which is crucial because inflammation is a key component of Metabolic Syndrome. By targeting inflammation, these treatments can help reduce the risk of cardiovascular diseases and improve overall metabolic health in patients with Metabolic Syndrome.

Dairy attentuates oxidative and inflammatory stress in metabolic syndrome.Effects of low-fat or full-fat fermented and non-fermented dairy foods on selected cardiovascular biomarkers in overweight adults.