Milk Consumption for Metabolic Syndrome

EB
Overseen ByEric Bruhn
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how consuming whole-fat dairy affects heart and metabolic health in adults with metabolic syndrome. Participants will follow two different diets: a full-fat dairy diet and a low-fat dairy diet, to assess their impact on health markers like blood sugar and cholesterol. It suits individuals with at least three signs of metabolic syndrome, such as high blood sugar, large waist size, or high blood pressure, who do not already consume much dairy or have a dairy allergy. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially improve personal health outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on medications related to metabolic syndrome and plan to change the dose during the study, you may not be eligible to participate.

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

Research has shown that replacing carbohydrates with fats in a diet can yield mixed results. Some studies find that this change can lower triglycerides, reduce blood sugar levels, and lower blood pressure, while also raising HDL cholesterol, known as "good" cholesterol. However, other research suggests that high-fat diets might lead to issues like insulin resistance and weight gain.

Conversely, low-fat diets, which derive 30% or less of their calories from fat, present their own challenges. Some studies link very-low-fat diets, particularly those with less than 15% fat, to a higher risk of metabolic syndrome, despite often having fewer calories overall.

Both high-fat and low-fat diets offer pros and cons. Consider how each might affect health, especially in the presence of metabolic syndrome.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the trial exploring milk consumption for metabolic syndrome because it takes a fresh look at dietary fat content as a treatment approach. Unlike standard treatments such as medication and lifestyle changes focused on reducing sugar and fat intake, this study compares the effects of full-fat and low-fat diets directly. This trial could reveal important insights about how different types of dietary fats influence metabolic health, potentially leading to more personalized and effective dietary recommendations. By understanding the impact of these diets on metabolic syndrome, researchers hope to uncover new strategies to manage and prevent the condition.

What evidence suggests that this trial's treatments could be effective for metabolic syndrome?

Research has shown that different types of dietary fat can affect health. In this trial, participants will follow either a full-fat diet or a low-fat diet in different sequences. For high-fat diets, studies suggest that replacing carbohydrates with fat can lower certain blood fats, blood sugar levels, and blood pressure, while raising HDL cholesterol, often known as the "good" cholesterol. Conversely, low-fat diets have been shown to alter factors related to metabolic health, such as weight and cholesterol, over time. A review of several studies found that low-fat diets can aid in weight loss and reduce some health risks. Both types of diets offer benefits, but their effects can vary from person to person.16789

Who Is on the Research Team?

JS

Joshua Smith, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with metabolic syndrome, characterized by low HDL cholesterol (below 40 mg/dL in men or 50 mg/dL in women), high triglycerides (150 mg/dL or above), elevated fasting glucose (100 mg/dL or above), large waist circumference (over 102 cm for men and 88 cm for women), and high blood pressure (130/80 mmHg or higher).

Inclusion Criteria

Presence of 3 of the following risk factors:
My blood pressure is high or I am on medication for it.
Waist circumference >102 cm for men and >88 cm for women
See 3 more

Exclusion Criteria

I am currently using a GLP-1 agonist medication.
My medication for metabolic syndrome will be adjusted during the study.
Dairy allergy or lactose intolerance
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume either a full-fat or low-fat dairy diet to assess impact on cardiovascular and metabolic risk factors

8 weeks
4 visits (in-person) at Baseline, Week 3, Week 5, and Week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Full-fat diet
  • Low-fat diet

Trial Overview

The study aims to compare the effects of a full-fat diet versus a low-fat diet on cardiovascular health, metabolism, and blood vessel function in individuals with metabolic syndrome.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Low-fat diet first then Full-fat dietExperimental Treatment2 Interventions
Group II: Full-fat diet first then Low-fat dietExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Effectiveness of a Lifestyle Intervention on Metabolic ... - PMC

The former significantly reduced total/saturated fat intake and increased polyunsaturated fat/fiber intake and exercise level compared to the controls. Weight, ...

Review Dietary fat intake and metabolic syndrome in adults

Thirty articles were selected (14 observational and 16 clinical trials), and we included information of dietary fat and fatty acids as well as MetS, body mass ...

Metabolic Syndrome—Role of Dietary Fat Type and Quantity

Most meta-analyses show that replacement of carbohydrates with fat lowers fasting TG and glucose and blood pressure, and increases HDL cholesterol.

Comparison of Weight-Loss Diets with Different ...

Other studies showed increased weight loss at 1 to 2 years with diets that were high in unsaturated fat or with low-fat, high-carbohydrate vegetarian diets.

Cardio-Metabolic Effects of High-Fat Diets and Their ...

Antioxidant and anti-inflammatory effects of Mediterranean diets are potential mediators of these benefits. Keywords: high-fat diet; saturated fatty acids; ...

High-fat diet and metabolic syndrome: Relationships

Ashino et al. Maternal high-fat feeding through pregnancy and lactation predisposes mouse offspring to molecular insulin resistance and fatty liver. Journal ...

Dietary Fat Intake and the Risk of Metabolic Syndrome ... - PMC

Because of the fact that there are different types of fatty acids in one food, adjusting for other types of diet or fat types with the main target fat should be ...

Metabolic syndrome: epidemiology, mechanisms, and ...

Excess visceral fat releases free fatty acids into the bloodstream, interfering with insulin signaling and leading to the accumulation of ...

A high-fat diet sets off metabolic dysfunction in cells ...

A study by MIT researchers shows that a high-fat diets sets off metabolic dysfunction in cells that leads to weight gain.