Dairy Products for Heart Health
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Tufts University
Must not be taking: Antibiotics, Steroids, NSAIDs, others
Disqualifiers: Hypertension, Diabetes, Heart disease, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
56789How 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.
48101112Eligibility 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.
+2 more
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.
+23 more
Trial 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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: Full-fat yogurt beverageExperimental Treatment1 Intervention
Beverage made with full-fat yogurt
Group II: Full-fat milk beverageExperimental Treatment1 Intervention
Beverage made with full-fat milk
Group III: Fat-free yogurt beverageExperimental Treatment1 Intervention
Beverage made with fat-free yogurt
Group IV: Fat-free milk beverageExperimental Treatment1 Intervention
Beverage made with fat-free milk
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Jean Mayer Human Nutrition Research Center on AgingBoston, MA
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Who Is Running the Clinical Trial?
Tufts UniversityLead Sponsor
References
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]Nowadays, the potential beneficial effects of probiotic yogurt as a functional food has raised much interest. Thus, the aim of this study was to compare the probiotic yogurt and ordinary yogurt consumption on some indices in patients with chronic heart failure (CHF).
Consumption of dairy products in youth, does it protect from cardio-metabolic risk? [2018]Introduction: The high prevalence of obesity in children and adolescents is considered as a major global health concern and involves the onset of other comorbidities such as hypertension, dyslipidemia, chronic infl ammation and hyperinsulinemia, which are also considered as cardiovascular diseases risk factors. Several studies have observed that consumption of dairy products has a protective role on the development of cardiovascular diseases; however, the scientific evidence on this topic is very limited among children and adolescents. Objectives: To investigate the association between dairy products consumption and cardiovascular risk factors in young populations. Material and methods: The most up-to-date literature was reviewed, including some data from the HELENA (Healthy Lifestyle in Europe by Nutrition in Adolescence) study. A sample of adolescents (12.5-17.5 years) from 8 European cities was considered for the analysis. Results: US data showed a decrease in both number of servings and portion sizes of milk consumption. Within the HELENA study, dairy products emerged as the food group that better distinguished those adolescents at lower cardiovascular diseases risk. Among the HELENA adolescents, higher consumption of milk, yogurt and milk- and yogurt-based beverages was associated with lower body fat, lower risk for cardiovascular diseases, and higher cardiorespiratory fitness. Conclusions: More studies are needed to provide more evidence and to better understand the intrinsic mechanisms of the association between dairy products consumption, especially yogurt consumption, and obesity, diabetes, and other cardiovascular diseases risk factors.
Yogurt and Cardiometabolic Diseases: A Critical Review of Potential Mechanisms. [2023]Associations between yogurt intake and risk of diet-related cardiometabolic diseases (CMDs) have been the subject of recent research in epidemiologic nutrition. A healthy dietary pattern has been identified as a pillar for the prevention of weight gain and CMDs. Epidemiologic studies suggest that yogurt consumption is linked to healthy dietary patterns, lifestyles, and reduced risk of CMDs, particularly type 2 diabetes. However, to our knowledge, few to no randomized controlled trials have investigated yogurt intake in relation to cardiometabolic clinical outcomes. Furthermore, there has been little attempt to clarify the mechanisms that underlie the potential beneficial effects of yogurt consumption on CMDs. Yogurt is a nutrient-dense dairy food and has been suggested to reduce weight gain and prevent CMDs by contributing to intakes of protein, calcium, bioactive lipids, and several other micronutrients. In addition, fermentation with bacterial strains generates bioactive peptides, resulting in a potentially greater beneficial effect of yogurt on metabolic health than nonfermented dairy products such as milk. To date, there is little concrete evidence that the mechanisms proposed in observational studies to explain positive results of yogurt on CMDs or parameters are valid. Many proposed mechanisms are based on assumptions that commercial yogurts contain strain-specific probiotics, that viable yogurt cultures are present in adequate quantities, and that yogurt provides a minimum threshold dose of nutrients or bioactive components capable of exerting a physiologic effect. Therefore, the primary objective of this review is to investigate the plausibility of potential mechanisms commonly cited in the literature in order to shed light on the inverse associations reported between yogurt intake and various cardiometabolic health parameters that are related to its nutrient profile, bacterial constituents, and food matrix. This article reviews current gaps and challenges in identifying such mechanisms and provides a perspective on the research agenda to validate the proposed role of yogurt in protecting against CMDs.
Effects of Kefir Consumption on Cardiometabolic Risk Factors: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]Fermentation of lactose in milk by bacteria and yeasts naturally present in kefir grains produces a beverage that has been suggested to have cardiovascular benefits. This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the effects of this kefir beverage on cardiometabolic risk factors.
Yogurt, cultured fermented milk, and health: a systematic review. [2021]Consumption of yogurt and other fermented products is associated with improved health outcomes. Although dairy consumption is included in most dietary guidelines, there have been few specific recommendations for yogurt and cultured dairy products. A qualitative systematic review was conducted to determine the effect of consumption of fermented milk products on gastrointestinal and cardiovascular health, cancer risk, weight management, diabetes and metabolic health, and bone density using PRISMA guidelines. English language papers in PubMed were searched, with no date restrictions. In total, 1057 abstracts were screened, of which 602 were excluded owing to lack of appropriate controls, potential biases, and experimental design issues. The remaining 455 papers were independently reviewed by both authors and 108 studies were included in the final review. The authors met regularly to concur, through consensus, on relevance, methods, findings, quality, and conclusions. The included studies were published between 1979 and 2017. From the 108 included studies, 76 reported a favorable outcome of fermented milks on health and 67 of these were considered to be positive or neutral quality according to the Academy of Nutrition and Dietetics' Quality Criteria Checklist. Of the 32 remaining studies, the study outcomes were either not significant (28) or unfavorable (4), and most studies (18) were of neutral quality. A causal relationship exists between lactose digestion and tolerance and yogurt consumption, and consistent associations exist between fermented milk consumption and reduced risk of breast and colorectal cancer and type 2 diabetes, improved weight maintenance, and improved cardiovascular, bone, and gastrointestinal health. Further, an association exists between prostate cancer occurrence and dairy product consumption in general, with no difference between fermented and unfermented products. This article argues that yogurt and other fermented milk products provide favorable health outcomes beyond the milk from which these products are made and that consumption of these products should be encouraged as part of national dietary guidelines. Systematic review registration: PROSPERO registration no. CRD42017068953.
Dairy products and its association with incidence of cardiovascular disease: the Malmö diet and cancer cohort. [2021]It is unclear whether specific dairy products are associated with risk of cardiovascular disease (CVD). The aim of this project was therefore to examine the association between intake of milk, cheese, cream and butter, and incidence of CVD in the Swedish Malmö Diet and Cancer cohort. Milk was separated into fermented (yoghurt and cultured sour milk) versus non-fermented milk, and low-fat versus high-fat milk. Among 26,445 individuals without a history of myocardial infarction, stroke and diabetes (44-74 years; 62% females), 2,520 CVD cases (coronary and stroke events) were identified during a mean follow-up time of 12 years. Dietary data was collected using a modified diet history method. Overall consumption of dairy products was inversely associated with risk of CVD (P (trend) = 0.05). Among the specific dairy products, a statistically significant inverse relationship was observed only for fermented milk. The highest versus lowest intake category of fermented milk was associated with 15% (95% CI: 5-24%; P (trend) = 0.003) decreased incidence of CVD. We observed a statistically significant interaction between sex and cheese intake (P = 0.046). Cheese intake was significantly associated with decreased CVD risk in women (P (trend) = 0.03), but not in men (P (trend) = 0.98). The main finding was that a high intake of fermented milk may reduce the risk of CVD. This study suggests that it is important to examine dairy products separately when investigating their health effects.
Intake of fermented and non-fermented dairy products and risk of incident CHD: the Kuopio Ischaemic Heart Disease Risk Factor Study. [2019]Recent dairy product studies have suggested that fermented rather than non-fermented dairy products might provide benefits on cardiovascular health, but the evidence is inconclusive. Therefore, we investigated whether fermented and non-fermented dairy products have distinct associations with the risk of incident CHD in a population with high dairy product intake. The present study included a total of 1981 men, aged 42-60 years, from the Kuopio Ischaemic Heart Disease Risk Factor Study, with no CHD at baseline. Dietary intakes were assessed with instructed 4-d food records. We used Cox's proportional hazards regression model to estimate the associations with the risk of CHD. Fatal and non-fatal CHD events were ascertained from national registries. During a mean follow-up of 20·1 years, 472 CHD events were recorded. Median intakes were 105 g/d for fermented (87 % low-fat products) and 466 g/d for non-fermented dairy products (60 % low-fat products). After adjusting for potential confounders, those in the highest (v. lowest) intake quartile of fermented dairy products had 27 % (95 % CI 5, 44; P-trend=0·02) lower risk of CHD. In contrast, those in the highest intake quartile of non-fermented dairy products had 52 % (95 % CI 13, 104; P-trend=0·003) higher risk of CHD. When analysed based on fat content, low-fat (
Fermented milks and milk products as functional foods--a review. [2019]Fermented foods and beverages possess various nutritional and therapeutic properties. Lactic acid bacteria (LAB) play a major role in determining the positive health effects of fermented milks and related products. The L. acidophilus and Bifidobacteria spp are known for their use in probiotic dairy foods. Cultured products sold with any claim of health benefits should meet the criteria of suggested minimum number of more than 10⁶ cfu/g at the time of consumption. Yoghurt is redefined as a probiotic carrier food. Several food powders like yoghurt powder and curd (dahi) powder are manufactured taking into consideration the number of organisms surviving in the product after drying. Such foods, beverages and powders are highly acceptable to consumers because of their flavor and aroma and high nutritive value. Antitumor activity is associated with the cell wall of starter bacteria and so the activity remains even after drying. Other health benefits of fermented milks include prevention of gastrointestinal infections, reduction of serum cholesterol levels and antimutagenic activity. The fermented products are recommended for consumption by lactose intolerant individuals and patients suffering from atherosclerosis. The formulation of fermented dietetic preparations and special products is an expanding research area. The health benefits, the technology of production of fermented milks and the kinetics of lactic acid fermentation in dairy products are reviewed here.
Fermented dairy foods rich in probiotics and cardiometabolic risk factors: a narrative review from prospective cohort studies. [2021]Probiotic foods, including fermented dairy (FD) products such as yogurt and cheese, naturally contain live microorganisms, but the relationship between the consumption of probiotic foods and health is unclear. The aim of the present narrative review is to integrate the available information on the relationship between the most studied FD products, which are yogurt and cheese, and cardiometabolic risk factors obtained from meta-analysis, systematic reviews of prospective cohort studies (PCSs) and PCSs published up to 2 November 2019. Additionally, the effects identified by randomized controlled trials of less-studied FD products, such as kefir and kimchi, on cardiometabolic risk factors are provided. PCSs have shown that the consumption of cheese, despite its high saturated fat content, is not associated with expected hypercholesterolemia and an increased cardiovascular risk. PCSs have revealed that the total consumption of FD appears to be associated with a lower risk of developing stroke and cardiovascular disease. The consumption of yogurt seems to be associated with a lower risk of developing type 2 diabetes. There is a lack of sufficient evidence of a protective relationship between FD or cheese consumption and metabolic syndrome. Moreover, the association of FD, cheese and yogurt with hypertension needs further evidence. In conclusion, the intake of fermented foods containing probiotics, particularly yogurt and cheese (of an undetermined type), opens up new opportunities for the management of cardiometabolic risk factors.
Effect of yogurt intake on plasma lipid and lipoprotein levels in normolipidemic males. [2019]To determine the effect of yogurt intake on plasma lipid and lipoprotein levels, studies were carried out in 18 normolipidemic males during 3 dietary phases. Phase 1 was a low-fat, low-cholesterol baseline diet consumed for 3 weeks. The baseline diet was supplemented with low-fat yogurt (16 oz/day) for 4 weeks during phase 2, and during phase 3 the supplement consisted of a non-fermented dairy product (16 oz low-fat milk plus 10% milk solids). Average body weights and dietary intakes of fat, cholesterol and polyunsaturate/saturate fat ratios were not significantly different for the 3 dietary phases. Plasma total, LDL- and HDL-cholesterol were unaffected by either the yogurt of low-fat milk concentrate. The results indicate that yogurt, as an example of a fermented dairy product, has no effect on plasma cholesterol levels of normolipidemic males.
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]Fermented milk products have been shown to affect serum cholesterol concentrations in humans. Kefir, a fermented milk product, has been traditionally consumed for its potential health benefits but has to date not been studied for its hypocholesterolemic properties.
History of yogurt and current patterns of consumption. [2018]Yogurt has been a part of the human diet for several millennia and goes by many names throughout the world. The word "yogurt" is believed to have come from the Turkish word "yoğurmak," which means to thicken, coagulate, or curdle. While references to the health-promoting properties of yogurt date back to 6000 BC in Indian Ayurvedic scripts, it was not until the 20th century that Stamen Grigorov, a Bulgarian medical student, attributed the benefits to lactic acid bacteria. Today, most yogurt is fermented milk that is acidified with viable and well-defined bacteria (Lactobacillus bulgaricus and Streptococcus thermophiles). While patterns of yogurt consumption vary greatly from country to country, consumption is generally low. In the United States and Brazil, for example, only 6% of the population consume yogurt on a daily basis. Low consumption of yogurt represents a missed opportunity to contribute to a healthy lifestyle, as yogurt provides a good to excellent source of highly bioavailable protein and an excellent source of calcium as well as a source of probiotics that may provide a range of health benefits.