Milk Polar Lipids for Abdominal Obesity

Overseen By Christopher N Blesso, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Connecticut

Must not be taking: Lipid-lowering, Anti-inflammatory, Blood clotting

Disqualifiers: Diabetes, Heart disease, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

130 Participants Needed

Trial Summary

What is the purpose of this trial?

The major objective of this project is to examine whether daily consumption of milk polar lipids (MPLs) influences cardiometabolic risk factors.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes people taking lipid-lowering medications, anti-inflammatory medications, and medications that affect blood clotting.

What data supports the effectiveness of the treatment Milk Polar Lipids for Abdominal Obesity?

Research shows that milk polar lipids, particularly those in the milk fat globule membrane (MFGM), have antioxidant and anti-inflammatory properties, which may help improve metabolic health. Additionally, MFGM has been shown to support cognitive development in infants and reduce colon cancer markers in rats, suggesting potential health benefits that could extend to managing abdominal obesity. ^{1 2 3 4 5}

Is Milk Polar Lipids treatment safe for humans?

Milk Polar Lipids, found in milk fat globule membranes (MFGM), have been used in various products like infant formula and are generally considered safe. Studies have shown positive effects on cognitive and immune health, and they have antioxidant and anti-inflammatory properties, suggesting they are safe for human consumption. ^{1 2 4 6 7}

How is the Milk Polar Lipid-Rich Dairy Powder treatment unique for abdominal obesity?

Milk Polar Lipid-Rich Dairy Powder is unique because it contains milk polar lipids, which have been shown to potentially improve gut health and reduce inflammation, factors that can contribute to obesity. Unlike other treatments, it leverages the natural properties of milk fat globule membrane components, which may help modulate gut bacteria and prevent weight gain in high-fat diets. ^{1 4 8 9 10}

Eligibility Criteria

This trial is for adults aged 40 to 70 with high LDL cholesterol (bad cholesterol) and a large waistline, indicating abdominal obesity. It's not suitable for individuals with gallbladder, thyroid, gut diseases, autoimmune or chronic inflammatory conditions, diabetes, recent antibiotic use, milk allergies/intolerances, or those on certain medications like statins.

Inclusion Criteria

Your LDL cholesterol level is higher than 130 mg/dL.

Your waist measurement is 88 cm or more if you are a woman, or 102 cm or more if you are a man.

I am between 40 and 70 years old.

Exclusion Criteria

I have a thyroid condition.

You are allergic or intolerant to milk products.

You have an eating disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume either a control dairy beverage or an MPL-rich dairy beverage daily

8 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dairy Powder
• Milk Polar Lipid-Rich Dairy Powder

Trial Overview The study tests if consuming a dairy powder rich in milk polar lipids daily can improve heart health and reduce risk factors associated with heart disease in people with high cholesterol and abdominal obesity.

Participant Groups

Group I: MPL-rich dairy powder Experimental Treatment 1 Intervention

Daily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks.

Group II: Control dairy powder Placebo Group 1 Intervention

Daily consumption of 50 g of dairy powder containing \<0.1 g MPL for 8 weeks

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Dairy Management Inc.

Industry Sponsor

Trials

21

Recruited

2,600+

Findings from Research

A new method was developed to enrich polar lipids from milk by-products, specifically from whey protein concentrate, resulting in a fraction containing 38.56% phospholipids, which can enhance the nutritional value of food products.

The enriched polar lipid fraction demonstrated significant antioxidant properties, increasing the oxidation stability of fish oil by over 30 times and reducing inflammation markers (IL-6 and TNF-α) in cell cultures, suggesting potential health benefits in functional foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation and Characterization of a Polar Milk Lipid-enriched Component from Whey Powder. Lee, K., Kim, A., Hong, KB., et al.[2020]

Supplementing obese rat dams with polar lipids-enriched milk fat globule membrane (MFGM-PL) during pregnancy and lactation significantly improves the skeletal growth of their male offspring, particularly at weaning.

In adulthood, MFGM-PL supplementation protects against bone degeneration and enhances insulin sensitivity in offspring, likely by boosting the growth hormone/insulin-like growth factor-1 (GH/IGF-1) axis, indicating long-term benefits for skeletal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Milk Polar Lipids Supplementation to Obese Rats During Pregnancy and Lactation Benefited Skeletal Outcomes of Male Offspring. Han, L., Du, M., Ren, F., et al.[2022]

In a study involving male Fischer-344 rats, those fed a diet containing milk fat globule membrane (MFGM) showed significantly fewer aberrant crypt foci (ACF), a marker of colon cancer risk, compared to those fed diets with corn oil or anhydrous milk fat, suggesting MFGM may have protective effects against colon carcinogenesis.

Despite the observed reduction in ACF with MFGM, gene expression analysis did not show changes in colon cancer-related genes, indicating that the mechanism of protection may not involve direct alterations in gene expression or sphingolipid profiles in the colonic mucosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary milk fat globule membrane reduces the incidence of aberrant crypt foci in Fischer-344 rats. Snow, DR., Jimenez-Flores, R., Ward, RE., et al.[2020]

Supplementation with bovine milk fat globule membrane (MFGM) in growth-restricted rat pups led to significant improvements in cognitive development, as indicated by better performance in the T-Maze test compared to those receiving sialic acid (SIA).

MFGM supplementation resulted in increased expression of key neurodevelopmental genes, particularly at postnatal day 14, suggesting that MFGM's complex mixture of components plays a crucial role in enhancing cognitive outcomes over its individual components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of milk fat globule membrane and its various components on neurologic development in a postnatal growth restriction rat model. Brink, LR., Gueniot, JP., Lönnerdal, B.[2020]

Milk fat globule membrane (MFGM) is a highly nutritious component of dairy products that encases milk fat globules, making it valuable in the food industry.

The review discusses various aspects of MFGM, including its composition, separation and preparation methods, and functional properties, which can guide its development and utilization in food products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancement on Milk Fat Globule Membrane: Separation, Identification, and Functional Properties. Wang, C., Qiao, X., Gao, Z., et al.[2023]

Regular intake of milk fat globule membranes (MFGMs) has been shown to positively impact neural and cognitive development, as well as immune and gastrointestinal health in both infants and the elderly.

By-products from butter and butter oil production, particularly buttermilk and butterserum, are identified as excellent sources for isolating MFGMs, which can be used to create biologically active ingredients for various health products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipidomic and Proteomic Profiling of the Milk Fat Globule Membrane from Different Industrial By-Products of the Butter and Butter Oil Manufacturing Process. Señoráns, M., Gallo, V., Calvo, MV., et al.[2023]

A comprehensive analysis of six commercial bovine milk fat globule membrane (MFGM) samples revealed significant variability in protein composition, with nearly 1,000 proteins identified and 364 showing different abundance levels, indicating that not all MFGM products are the same.

Lipidomic analysis found that triglycerides made up at least 50% of the total lipids in the MFGM samples, along with notable amounts of phosphatidylcholine and sphingomyelin, highlighting the complex lipid profile that may influence the functional benefits of MFGM in products like infant formula.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omics analysis reveals variations among commercial sources of bovine milk fat globule membrane. Brink, LR., Herren, AW., McMillen, S., et al.[2020]

Milk polar lipids, which are a small but significant component of milk fat, may positively influence various health issues such as lipid metabolism, gut health, inflammation, and cardiovascular disease, based on recent research.

The varying content of polar lipids in different dairy products suggests that both full-fat and reduced-fat dairy could have unique health benefits, but further clinical studies are needed to confirm these effects in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Milk Polar Lipids: Underappreciated Lipids with Emerging Health Benefits. Anto, L., Warykas, SW., Torres-Gonzalez, M., et al.[2023]

In a study with male C57Bl/6 mice fed a high-fat diet for 8 weeks, supplementation with milk polar lipids (MPL) significantly reduced weight gain, particularly at a higher dose (1.6% MPL).

MPL also positively influenced gut health by increasing colonic crypt depth and altering gut microbiota composition, suggesting potential benefits in managing obesity-related metabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Milk Polar Lipids in a High-Fat Diet Can Prevent Body Weight Gain: Modulated Abundance of Gut Bacteria in Relation with Fecal Loss of Specific Fatty Acids. Milard, M., Laugerette, F., Durand, A., et al.[2019]

Milk fat globule membrane (MFGM) fragments, which are rich in polar lipids and proteins, can be effectively purified from acid buttermilk cheese whey, yielding a recovery of 91.0% of whey polar lipids under optimal conditions (pH 7.7, 55 degrees C, and 0.205 g calcium/L).

The purification process demonstrated that pH significantly influences the recovery of MFGM fragments, while washing and centrifugation can effectively remove sugars without substantial loss of polar lipids, although excessive washing can lead to loss of MFGM material.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermocalcic aggregation of milk fat globule membrane fragments from acid buttermilk cheese whey. Rombaut, R., Dewettinck, K.[2020]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Preparation and Characterization of a Polar Milk Lipid-enriched Component from Whey Powder. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Milk Polar Lipids Supplementation to Obese Rats During Pregnancy and Lactation Benefited Skeletal Outcomes of Male Offspring. [2022]

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

Dietary milk fat globule membrane reduces the incidence of aberrant crypt foci in Fischer-344 rats. [2020]

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

Effects of milk fat globule membrane and its various components on neurologic development in a postnatal growth restriction rat model. [2020]

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

Advancement on Milk Fat Globule Membrane: Separation, Identification, and Functional Properties. [2023]

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

Lipidomic and Proteomic Profiling of the Milk Fat Globule Membrane from Different Industrial By-Products of the Butter and Butter Oil Manufacturing Process. [2023]

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

Omics analysis reveals variations among commercial sources of bovine milk fat globule membrane. [2020]

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

Milk Polar Lipids: Underappreciated Lipids with Emerging Health Benefits. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Milk Polar Lipids in a High-Fat Diet Can Prevent Body Weight Gain: Modulated Abundance of Gut Bacteria in Relation with Fecal Loss of Specific Fatty Acids. [2019]

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

Thermocalcic aggregation of milk fat globule membrane fragments from acid buttermilk cheese whey. [2020]