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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether consuming milk polar lipids, a type of fat found in dairy, can reduce risks related to heart and metabolic health. Participants will take either a dairy powder rich in these lipids or a standard dairy powder for eight weeks. It is ideal for individuals with high LDL cholesterol and larger waistlines. As an Early Phase 1 trial, the research aims to understand how these lipids function in people, offering participants a chance to explore this potential health benefit.

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.

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

Research has shown that milk polar lipids (MPLs) are generally safe for consumption. In one study, a formula containing milk fat globule membrane (a component of MPLs) was safe and well-tolerated by infants, with side effects similar to those normally expected in this age group.

Another study involving healthy adults found that high doses of milk fat globule membrane did not cause major safety issues, as participants reported no significant side effects.

These findings suggest that MPLs can be safely consumed. However, it is important to note that this trial is in an early stage, and the treatment is still being tested for safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for abdominal obesity, which often involve medications or invasive procedures, the milk polar lipid (MPL)-rich dairy powder offers a more natural approach. This treatment is unique because it harnesses the power of milk polar lipids, believed to impact fat metabolism and potentially aid in reducing abdominal fat. Researchers are excited about this treatment's potential to provide a dietary alternative that is easy to incorporate into daily life, possibly offering a safer and more accessible option for managing abdominal obesity.

What evidence suggests that milk polar lipids might be an effective treatment for abdominal obesity?

Research has shown that certain fats in milk, known as polar lipids, might aid in obesity management by influencing fat metabolism. One study found that these fats, present in milk fat globule membranes, helped animals on high-fat diets gain less weight and reduce body fat. These lipids also appeared to lower blood levels of insulin and triglycerides, both linked to obesity and related health issues. Another study suggested that milk polar lipids can enhance gut health and reduce inflammation, both crucial for managing obesity. Evidence also indicates that these lipids can lower "bad" cholesterol (LDL) without affecting "good" cholesterol (HDL). These findings suggest that milk polar lipids could support weight management and improve overall health. In this trial, participants will receive either a milk polar lipid-rich dairy powder or a control dairy powder to evaluate these potential benefits. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5872749/

Milk Fat Globule Membrane Attenuates High-Fat Diet ... The aim of the current study was to investigate whether MFGM could prevent obesity through inhibiting adipogenesis and promoting brown remodeling of white ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7230917/

Milk Polar Lipids: Underappreciated Lipids with Emerging ... Milk polar lipids suggest they may beneficially influence dysfunctional lipid metabolism, gut dysbiosis, inflammation, cardiovascular disease, gut health, and ...

3. faseb.onlinelibrary.wiley.com faseb.onlinelibrary.wiley.com/doi/full/10.1096/fj.201901867RRR

Supplementation of polar lipids‐enriched milk fat globule ... MFGM-PL treatment to HFD dams decreased the body weight gain and WAT mass as well as lowered the serum levels of insulin and triglycerides in male offspring at ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022030224010798

Dietary milk phospholipids increase body fat and modulate ... The study examined how dietary milk polar lipids affect gut permeability, systemic inflammation, and lipid metabolism during diet-induced obesity (DIO).

5. mdpi.com mdpi.com/2304-8158/13/17/2725

Milk Fat Globule Membrane Is Associated with Lower ... Overall, MFGM phospholipid intake may significantly decrease the level of TC and LDL, while no significant changes in TG and HDL were observed.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0022030224008592

Milk fat globule membrane proteins are crucial in ... These results show that both MPL and MemP are indispensable in the construction of MFGM. Understanding their effects on digestion can provide new strategies.

7. tandfonline.com tandfonline.com/doi/full/10.1080/10408398.2022.2104211

Full article: Milk polar lipids composition and functionality Safety evaluation of the consumption of high dose milk fat globule membrane in healthy adults: A double-blind, randomized controlled trial ...

8. gut.bmj.com gut.bmj.com/content/69/3/487

Milk polar lipids reduce lipid cardiovascular risk factors in ... Milk PL significantly reduced fasting and postprandial plasma concentrations of cholesterol and surrogate lipid markers of cardiovascular disease risk.

9. faseb.onlinelibrary.wiley.com faseb.onlinelibrary.wiley.com/doi/full/10.1096/fj.202001974RRR

Supplementation of milk polar lipids to obese dams improves ... Safety evaluation of the consumption of high dose milk fat globule membrane in healthy adults: a double-blind, randomized controlled trial ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9347101/

Safety and tolerance assessment of milk fat globule ... MFGM-enriched formula was safe and well-tolerated in healthy term infants between 0 and 12 months, and total incidences of adverse events were similar to that ...