Dairy Products for Heart Health

Overseen By Jean Galluccio, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Must not be taking: Antibiotics, Steroids, NSAIDs, others

Disqualifiers: Hypertension, Diabetes, Heart disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to compare the effect of consuming full-fat (regular) and fat-free (skim) milk, as well as full-fat and fat-free yogurt (a fermented dairy product), on microorganisms in your gut as well as the products produced by the gut microbes. We will also determine whether consuming these dairy products affects risk factors for heart disease.The findings of the study will help us determine if heart disease risk factors are modified by the fat content and fermentation of milk. The results may facilitate refinement of public health dietary guidance for cardiovascular disease risk reduction.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, including oral antibiotics, steroids, lipid-lowering medications, chronic use of aspirin, NSAIDs, laxatives, anti-diarrheal medication, and regular use of acid-lowering medications. If you are taking any of these, you may need to stop before joining the study.

What data supports the effectiveness of the treatment 'Dairy Products for Heart Health'?

Research suggests that consuming fermented dairy products like yogurt and kefir may improve heart health by reducing risk factors for cardiovascular diseases, such as lower body fat and improved metabolic health. These benefits are linked to the nutrients and probiotics found in these products, which can help manage weight and improve overall cardiovascular health. ^{1 2 3 4 5}

Is it safe to consume dairy products like milk and yogurt for heart health?

Research suggests that consuming fermented dairy products like yogurt and cultured milk is generally safe and may even reduce the risk of heart disease. These products are associated with various health benefits, including improved cardiovascular health, without significant safety concerns. ^{5 6 7 8 9}

How is the treatment of dairy products for heart health unique compared to other treatments?

The treatment using dairy products like milk and yogurt is unique because it involves fermented foods that contain probiotics, which are beneficial bacteria that can improve gut health and potentially offer cardiovascular benefits. Unlike traditional medications, this approach uses natural food products that are generally well-tolerated and can be easily incorporated into daily diets. ^{4 8 10 11 12}

Research Team

Alice H Lichtenstein, D. Sc.

Principal Investigator

Tufts University

Eligibility Criteria

This trial is for men and postmenopausal women over 50 with a BMI between 25-35, who don't smoke, have regular bowel movements, and are not on certain medications. Excluded are those underweight or overweight beyond the set limits, recent smokers or nicotine users, hormone therapy recipients, anemia patients within two years, recent blood donors or antibiotic users.

Inclusion Criteria

I am over 50 years old.

Your body mass index (BMI) is between 25 and 35.

You have regular bowel movements at least every other day.

Exclusion Criteria

I have not taken oral antibiotics in the last 2 weeks.

You have donated blood in the last 2 months.

I have a chronic gastrointestinal condition that could affect the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fat-free milk phase

Participants consume 2 servings per day of fat-free milk for 3 weeks

3 weeks

2 visits (in-person) for measurements and sample collection

Full-fat milk phase

Participants consume 2 servings per day of full-fat milk for 3 weeks

3 weeks

2 visits (in-person) for measurements and sample collection

Fat-free yogurt phase

Participants consume 2 servings per day of fat-free yogurt for 3 weeks

3 weeks

2 visits (in-person) for measurements and sample collection

Full-fat yogurt phase

Participants consume 2 servings per day of full-fat yogurt for 3 weeks

3 weeks

2 visits (in-person) for measurements and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Milk or yogurt beverage

Trial Overview The study tests how full-fat and fat-free milk and yogurt affect gut microbes and heart disease risk factors. Participants will consume these dairy products to see if fat content and fermentation influence cardiovascular health.

Participant Groups

Group I: Full-fat yogurt beverage Experimental Treatment 1 Intervention

Beverage made with full-fat yogurt

Group II: Full-fat milk beverage Experimental Treatment 1 Intervention

Beverage made with full-fat milk

Group III: Fat-free yogurt beverage Experimental Treatment 1 Intervention

Beverage made with fat-free yogurt

Group IV: Fat-free milk beverage Experimental Treatment 1 Intervention

Beverage made with fat-free milk

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Findings from Research

In a study involving 90 patients with chronic heart failure, those consuming probiotic yogurt for 10 weeks showed a significant reduction in oxidized low-density lipoprotein (oxLDL) levels compared to those consuming ordinary yogurt, suggesting a potential benefit for heart health.

While both groups experienced a decrease in pentraxin3 (PTX3) levels, the difference was not statistically significant, indicating that probiotic yogurt may specifically improve oxidative status in CHF patients rather than affecting all inflammatory markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin3, NT-proBNP, oxLDL, and ApoB100 in patients with chronic heart failure: a randomized, triple-blind, controlled trial. [2021]

Higher consumption of dairy products, particularly milk and yogurt, in adolescents is associated with lower body fat and a reduced risk of cardiovascular diseases, as indicated by data from the HELENA study involving adolescents aged 12.5-17.5 years from 8 European cities.

The study suggests that dairy products may play a protective role against cardiovascular risk factors in young populations, but further research is needed to understand the underlying mechanisms of this association.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of dairy products in youth, does it protect from cardio-metabolic risk? Santaliestra-Pasías, AM., Bel-Serrat, S., Moreno, LA., et al.[2018]

Epidemiological studies suggest that yogurt consumption is associated with healthier dietary patterns and a reduced risk of cardiometabolic diseases (CMDs), particularly type 2 diabetes, but there is a lack of randomized controlled trials to confirm these findings.

The review highlights that while yogurt is nutrient-dense and may offer benefits due to its protein, calcium, and bioactive components, the mechanisms behind its protective effects against CMDs remain unclear and require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yogurt and Cardiometabolic Diseases: A Critical Review of Potential Mechanisms. Fernandez, MA., Panahi, S., Daniel, N., et al.[2023]

Kefir consumption significantly reduces fasting insulin levels and insulin resistance (HOMA-IR), indicating potential benefits for managing blood sugar levels and metabolic health, based on a meta-analysis of six randomized controlled trials involving 314 subjects.

However, kefir did not show any significant effects on body weight, fasting blood sugar, hemoglobin A1c, or lipid profiles, suggesting that while it may help with insulin sensitivity, it does not impact other cardiometabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Kefir Consumption on Cardiometabolic Risk Factors: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Yahyapoor, F., Haghighat, N., Sohrabi, Z., et al.[2023]

A systematic review of 108 studies found that consumption of yogurt and other fermented milk products is associated with improved health outcomes, including reduced risks of breast and colorectal cancer, type 2 diabetes, and enhanced cardiovascular and gastrointestinal health.

The review supports the idea that yogurt consumption can aid in lactose digestion and tolerance, and suggests that these fermented products should be encouraged in national dietary guidelines due to their overall health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yogurt, cultured fermented milk, and health: a systematic review. Savaiano, DA., Hutkins, RW.[2021]

In a study of 26,445 individuals over 12 years, high intake of fermented milk was associated with a 15% reduced risk of cardiovascular disease (CVD), indicating its potential protective effect.

Cheese intake was linked to decreased CVD risk specifically in women, suggesting that different dairy products may have varying health impacts based on sex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dairy products and its association with incidence of cardiovascular disease: the Malmö diet and cancer cohort. Sonestedt, E., Wirfält, E., Wallström, P., et al.[2021]

In a study of 1981 men over a mean follow-up of 20.1 years, high intake of fermented dairy products was associated with a 27% lower risk of coronary heart disease (CHD), while high intake of non-fermented dairy products was linked to a 52% higher risk of CHD.

Specifically, low-fat fermented dairy products were beneficial, showing a reduced risk of CHD, whereas neither high-fat fermented nor any non-fermented dairy products showed a protective effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intake of fermented and non-fermented dairy products and risk of incident CHD: the Kuopio Ischaemic Heart Disease Risk Factor Study. Koskinen, TT., Virtanen, HEK., Voutilainen, S., et al.[2019]

Lactic acid bacteria (LAB), particularly L. acidophilus and Bifidobacteria spp, are crucial for the health benefits of fermented dairy products, which should contain more than 10⁶ cfu/g for probiotic claims.

Fermented milks offer various health benefits, including prevention of gastrointestinal infections, reduction of cholesterol levels, and are suitable for lactose intolerant individuals, highlighting their therapeutic potential and consumer acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermented milks and milk products as functional foods--a review. Shiby, VK., Mishra, HN.[2019]

Consumption of fermented dairy products like yogurt and cheese is associated with a lower risk of developing type 2 diabetes and cardiovascular diseases, despite cheese's high saturated fat content.

Current evidence suggests that while fermented dairy may help manage certain cardiometabolic risk factors, more research is needed to clarify its effects on hypertension and metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermented dairy foods rich in probiotics and cardiometabolic risk factors: a narrative review from prospective cohort studies. Companys, J., Pedret, A., Valls, RM., et al.[2021]

In a study involving 18 normolipidemic males, yogurt intake (16 oz/day) for 4 weeks did not affect plasma total, LDL, or HDL cholesterol levels compared to a baseline low-fat, low-cholesterol diet.

Similarly, a non-fermented dairy product (low-fat milk) also showed no impact on cholesterol levels, indicating that yogurt and low-fat milk do not influence plasma lipid profiles in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of yogurt intake on plasma lipid and lipoprotein levels in normolipidemic males. McNamara, DJ., Lowell, AE., Sabb, JE.[2019]

In a study involving 13 healthy men with mildly high cholesterol, kefir supplementation for 4 weeks did not lower total cholesterol or other lipid levels, indicating it may not be effective as a cholesterol-lowering agent.

However, kefir did increase the levels of certain beneficial short-chain fatty acids in feces and improved fecal bacterial content, suggesting potential positive effects on gut health despite its lack of impact on cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kefir consumption does not alter plasma lipid levels or cholesterol fractional synthesis rates relative to milk in hyperlipidemic men: a randomized controlled trial [ISRCTN10820810]. St-Onge, MP., Farnworth, ER., Savard, T., et al.[2019]

Yogurt, which has been consumed for thousands of years, is made from fermented milk using beneficial bacteria like Lactobacillus bulgaricus and Streptococcus thermophiles, contributing to its health benefits.

Despite its nutritional advantages, including high-quality protein, calcium, and probiotics, yogurt consumption is low in countries like the United States and Brazil, indicating a missed opportunity for improving public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

History of yogurt and current patterns of consumption. Fisberg, M., Machado, R.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin3, NT-proBNP, oxLDL, and ApoB100 in patients with chronic heart failure: a randomized, triple-blind, controlled trial. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

Consumption of dairy products in youth, does it protect from cardio-metabolic risk? [2018]

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

Yogurt and Cardiometabolic Diseases: A Critical Review of Potential Mechanisms. [2023]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Effects of Kefir Consumption on Cardiometabolic Risk Factors: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]

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

Yogurt, cultured fermented milk, and health: a systematic review. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Dairy products and its association with incidence of cardiovascular disease: the Malmö diet and cancer cohort. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Intake of fermented and non-fermented dairy products and risk of incident CHD: the Kuopio Ischaemic Heart Disease Risk Factor Study. [2019]

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

Fermented milks and milk products as functional foods--a review. [2019]

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

Fermented dairy foods rich in probiotics and cardiometabolic risk factors: a narrative review from prospective cohort studies. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

Effect of yogurt intake on plasma lipid and lipoprotein levels in normolipidemic males. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Kefir consumption does not alter plasma lipid levels or cholesterol fractional synthesis rates relative to milk in hyperlipidemic men: a randomized controlled trial [ISRCTN10820810]. [2019]

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

History of yogurt and current patterns of consumption. [2018]