Dairy Fat for Obesity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Anti-obesity agents, Corticoid steroids

Disqualifiers: Diabetes, Cancer, Autoimmune, Gastrointestinal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different types of fat, specifically dairy fat and palm fat, affect post-meal inflammation, particularly in people with metabolic syndrome or obesity. Participants will consume shakes made with these fats, sometimes combined with milk fat globule membrane (MFGM), to observe bodily reactions. It is ideal for those dealing with central obesity or other metabolic issues, such as high cholesterol or blood pressure. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially improve personal health outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have started statin therapy, anti-inflammatory supplements, or certain over-the-counter anti-obesity agents in the last 12 weeks. Daily use of anti-inflammatory pain medication is also not allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that eating high-fat dairy products does not cause obesity, diabetes, or heart disease and might even benefit health. Studies indicate that increasing dairy intake could lower the risk of being overweight, with no general link to negative health effects for dairy consumers.

Milk Fat Globule Membrane (MFGM), a natural component of milk rich in nutrients, may improve health. Research suggests that MFGM can lower bad cholesterol levels without affecting good cholesterol and is associated with positive effects on metabolism and inflammation.

Palm fat, another type of fat used in this study, is more debated. Some research indicates it can cause inflammation and might not be ideal for those concerned about obesity. However, the evidence is mixed, and more research is needed to fully understand its effects.

When combined with MFGM, early studies suggest palm fat could help reduce inflammation. MFGM might protect the gut and support the immune system, making this combination potentially safer and more beneficial.

Overall, the safety of these fats appears promising, but it is important to consider individual health conditions and consult a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for obesity because they explore the potential benefits of dairy fat and milk fat globule membrane (MFGM) compared to traditional fats. Unlike common weight management approaches that often limit fat intake, these treatments examine how specific types of fat, like those from dairy or enhanced with MFGM, might influence metabolism and weight differently. MFGM, rich in proteins and phospholipids, could offer unique health benefits by potentially impacting fat absorption and energy expenditure. This study could shed light on whether these specialized fat sources can be more effective than current dietary fats in managing obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare the effects of different fat sources on obesity. Research has shown that dairy fat, one of the treatments in this trial, might help reduce body fat. A study review found a small decrease in body fat for those who consume dairy and suggests that people who eat more dairy are less likely to be overweight. Another treatment option in this trial is dairy fat combined with MFGM (milk fat globule membrane), which studies indicate might help prevent weight gain by reducing inflammation and promoting healthier fat cells. In contrast, palm fat, another treatment arm, has not shown any significant effects on weight or body size. However, when combined with MFGM, as tested in this trial, palm fat might improve how the body uses insulin and reduce inflammation. Overall, promising evidence supports dairy fat and its combination with MFGM, while palm fat alone seems less effective. ^{2 3 4 6 7}

Who Is on the Research Team?

Jennifer T Smilowitz, PhD

Principal Investigator

UC Davis

Angela M. Zivkovic, PhD

Principal Investigator

University of California, Davis

Marta Van Loan, PhD

Principal Investigator

ARS USDA WHNRC

J. Bruce German, PhD

Principal Investigator

UC Davis

Bruce Hammock, PhD

Principal Investigator

UC Davis

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have at least two symptoms of metabolic syndrome.

You have a body mass index (BMI) of 30 or higher.

Exclusion Criteria

You are a smoker or use other tobacco products.

You weigh more than 400 pounds.

Known allergy or intolerance to study food (lactose intolerance, dairy, wheat allergies)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume four different shakes on separate days to assess the effects of dairy fat fractions on postprandial inflammation

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dairy fat
• Dairy fat + MFGM
• Palm fat
• Palm fat + MFGM

Trial Overview 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.

How Is the Trial Designed?

Group I: Palm fat + MFGM Experimental Treatment 1 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 + MFGM Experimental Treatment 1 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 fat Active Control 1 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 protein powder.

Group IV: Dairy fat Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Dairy Research Institute

Collaborator

Trials

18

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05417347?draw=2&rank=1

Full-fat Dairy Products, Body Weight Control and Metabolic ... The proposed research will provide timely data required to support recommendations to consume low and full-fat dairy products in individuals living with obesity ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11889060/

The effect of fermented dairy intake and abdominal obesity in ... Specifically, a linear decrease in abdominal obesity risk was observed with the consumption of 8 to 21 servings per week of high-fat fermented ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3441106/

Effects of dairy intake on body weight and fat: a meta-analysis ... Twenty-two RCTs that reported results on body fat showed a modest reduction in the dairy group (−0.45 kg; 95% CI: −0.79, −0.11 kg; I2 = 70.9%), and further ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323000704

Consumption of Dairy Products and the Risk of Overweight ... The risk decreased by 25%, 7%, and 12% per 200-g/d increase for total dairy, high-fat dairy, and milk, respectively, and by 13% per 50-g/d increment of yogurt.

5. nature.com nature.com/articles/s41430-025-01639-5

Association between dairy intake and multiple health ... Across outcomes, most reviews reported no association between fat content of milk or dairy foods and adverse health outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6014779/

The dairy fat paradox: Whole dairy products may be healthier ... Recent studies demonstrate that high fat dairy does not cause obesity (5) or contribute to diabetes (6), or cardiovascular disease (3, 4); in fact, it may even ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322004355

Dairy Foods, Obesity, and Metabolic Health: The Role of ... Dairy consumption led to a reduction in fat mass (0.23 kg) and an increase in lean body mass (0.37 kg). Overall, high-dairy intervention increased body weight ( ...