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

38 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Dairy fat for Obesity?

Some studies suggest that high dairy fat intake might be linked to less central obesity, but results are mixed. Another study found that consistent non-fat milk intake was associated with lower abdominal fat, indicating that the type of dairy fat consumed may influence obesity outcomes. ^{1 2 3 4 5}

Is dairy fat safe for human consumption?

Emerging scientific evidence suggests that consuming regular-fat dairy foods is not linked to a higher risk of heart disease and may even help with weight management and reducing obesity risk. Dairy products like milk, cheese, and yogurt can be part of a healthy diet. ^{6 7 8 9 10}

How does the treatment using dairy fat and MFGM differ from other obesity treatments?

This treatment is unique because it uses dairy fat and milk fat globule membrane (MFGM), which may reduce inflammation and improve insulin response after meals, potentially offering benefits for obesity management that differ from traditional low-fat or pharmaceutical approaches. ^{2 6 11 12 13}

Research Team

Bruce Hammock, PhD

Principal Investigator

UC Davis

Angela M. Zivkovic, PhD

Principal Investigator

University of California, Davis

J. Bruce German, PhD

Principal Investigator

UC Davis

Jennifer T Smilowitz, PhD

Principal Investigator

UC Davis

Marta Van Loan, PhD

Principal Investigator

ARS USDA WHNRC

Eligibility Criteria

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.

I am between 18 and 65 years old.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Dairy Foods in a Moderate Energy Restricted Diet Do Not Enhance Central Fat, Weight, and Intra-Abdominal Adipose Tissue Losses nor Reduce Adipocyte Size or Inflammatory Markers in Overweight and Obese Adults: A Controlled Feeding Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

High dairy fat intake related to less central obesity: a male cohort study with 12 years' follow-up. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Differential effects of high fat diets on fatty acid composition in milk of Jersey and Holstein cows. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Dietary consequences of recommending reduced-fat dairy products in the weight-loss context: a secondary analysis with practical implications for registered dietitians. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Milk-Fat Intake and Differences in Abdominal Adiposity and BMI: Evidence Based on 13,544 Randomly-Selected Adults. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Regular-Fat Dairy and Human Health: A Synopsis of Symposia Presented in Europe and North America (2014-2015). [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Functional properties of butter oil made from bovine milk with experimentally altered fat composition. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Alternative and Unconventional Feeds in Dairy Diets and Their Effect on Fatty Acid Profile and Health Properties of Milk Fat. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Oxidation and textural characteristics of butter and ice cream with modified fatty acid profiles. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of varying levels of fatty acids from palm oil on feed intake and milk production in Holstein cows. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Alleviation of Metabolic Endotoxemia by Milk Fat Globule Membrane: Rationale, Design, and Methods of a Double-Blind, Randomized, Controlled, Crossover Dietary Intervention in Adults with Metabolic Syndrome. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Addition of a dairy fraction rich in milk fat globule membrane to a high-saturated fat meal reduces the postprandial insulinaemic and inflammatory response in overweight and obese adults. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

The relationship between high-fat dairy consumption and obesity, cardiovascular, and metabolic disease. [2022]