Dietary Intervention for Metabolic Diseases

(PREMIER Trial)

Overseen By Jordi Merino, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Glucocorticoids, Fluoroquinolones

Disqualifiers: Diabetes, Obesity, Heart attack, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how genetic makeup influences individual responses to specific foods. It focuses on understanding how genetic traits affect food choices and blood sugar levels, potentially aiding in the design of better prevention strategies for obesity and type 2 diabetes. Participants will receive meals and have their blood sugar and other markers checked to observe their reactions. The study seeks healthy individuals without diabetes or major health problems, who are not significantly overweight or underweight, and are willing to follow the study guidelines. Participants will join the PREMIER dietary intervention program. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to personalized nutrition strategies.

Will I have to stop taking my current medications?

If you are taking medications for type II diabetes or any medication known to affect blood sugar levels, you will not be able to participate in the study. The trial does not specify other medication restrictions, so it's best to discuss your current medications with the study team.

What prior data suggests that this dietary intervention is safe?

Research has shown that dietary changes, like those in the PREMIER study, are generally safe. Previous studies found that the DASH diet, part of the PREMIER lifestyle changes, can lower blood pressure in individuals with certain health issues. This diet emphasizes fruits, vegetables, and low-fat dairy while being low in unhealthy fats.

No major reports of negative effects from this type of diet change have emerged, indicating it is well-tolerated. Since the study focuses on diet, it is less likely to cause the side effects often seen in medication studies. However, individual differences matter, so consider personal health conditions or allergies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PREMIER dietary intervention because it explores how genetic differences can influence the effectiveness of diet-based treatments for metabolic diseases. Unlike standard treatments that often involve medications or generalized dietary advice, this approach tailors dietary interventions based on an individual's genetic makeup. This personalized approach has the potential to offer more effective and targeted management of metabolic conditions, leading to better health outcomes for those with specific genetic susceptibilities.

What evidence suggests that this dietary intervention could be effective for metabolic diseases?

Research has shown that following healthy eating guidelines can significantly reduce the risk of obesity and type 2 diabetes. Large studies have found that these diets help reduce belly fat and improve overall health, such as lowering certain fats in the blood. The PREMIER study, which participants in this trial may join, examines how genes influence food preferences and bodily reactions. Early results suggest that genetic differences can affect food choices and how the body processes food for energy. Understanding these connections could help predict who will benefit most from specific dietary changes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

The PREMIER study is for men and women aged 21-65 with a BMI of 18.5 to 30, who are generally healthy and willing to follow the dietary intervention. It's not for those with heart issues, depression, certain diseases like diabetes or inflammatory conditions, or anyone on medications affecting blood sugar.

Inclusion Criteria

I am between 21 and 65 years old.

I am either male or female.

Your body mass index (BMI) is between 18.5 and 30.0 kg/m2.

Exclusion Criteria

You are very overweight or underweight based on your height.

Are participating in another clinical study

I have a history of cirrhosis or my liver enzymes are more than three times the normal limit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a standardized and an election meal to measure the response of blood glucose and other biomarkers

1 day

1 full-day clinic visit

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PREMIER

Trial Overview This trial tests how different people respond to specific foods based on their genetic makeup. Participants will eat a standardized meal so researchers can measure changes in blood glucose and other biomarkers related to food preferences and metabolic health.

How Is the Trial Designed?

Group I: Genotype of interest group Active Control 1 Intervention

Individuals with desired genetic susceptibility will receive a standardized and an election meal in a full-day clinic visit.

Group II: Control Placebo Group 1 Intervention

Individuals without genotype of interest (i.e., carrying the opposite genotype) will receive a standardized and an election meal in a full-day clinic visit.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

NORCH (Nutrition Obesity Research Center at Harvard)

Collaborator

Trials

2

Recruited

60+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Boston Area Diabetes Endocrinology Research Center

Collaborator

Trials

1

Recruited

30+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2219825/

Effectiveness of a Lifestyle Intervention on Metabolic ... The intervention significantly reduced the prevalence of central obesity (OR = 0.33; 0.20–0.56), and hypertriglyceridemia (OR = 0.48; 0.31–0.75) and the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04148482

PREMIER: PREvention of Metabolic Illness Through ... Large, high-quality clinical trials have shown that close adherence to healthy dietary recommendations significantly reduce the incidence of obesity and type 2 ...

3. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.107.089458?doi=10.1161/HYPERTENSIONAHA.107.089458

Effects of PREMIER Lifestyle Modifications on Participants ... In a randomized trial of patients with MetSyn, the DASH dietary pattern has been shown to be more effective than a “control diet” (50% to 60% carbohydrate, 15% ...

4. mdpi.com mdpi.com/2072-6643/17/7/1257

The Impact of Dietary Interventions on Metabolic Outcomes ... Conclusions: This review suggests that MED and IF-based strategies may reduce BW, improve glycemic control, and lower inflammation, with potential benefits for ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1279770724003762

Precision nutrition impact on metabolic health and quality ... The precision group exhibited key metabolic improvements in weight loss, blood pressure, glycemic control, hepatic health and other cardiometabolic risk factors ...

6. ahajournals.org ahajournals.org/doi/10.1161/hypertensionaha.107.089458

Effects of PREMIER Lifestyle Modifications on Participants ... Our data suggest that strategies for lowering BP in individuals with metabolic syndrome may be enhanced by recommendations to adopt the DASH dietary pattern.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3047997/

Lifestyle modification in the management of the metabolic ... In the PREMIER study, the Dietary Approaches to Stop Hypertension diet (rich in fruit, vegetables, and low-fat dairy foods, and low in saturated and total fat ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17698724/

Effects of PREMIER lifestyle modifications on participants with ... Our data suggest that strategies for lowering BP in individuals with metabolic syndrome may be enhanced by recommendations to adopt the DASH dietary pattern.

9. ahajournals.org ahajournals.org/doi/pdf/10.1161/HYPERTENSIONAHA.107.089458

Effects of PREMIER Lifestyle Modifications on Participants ... Our data suggest that strategies for lowering BP in individuals with metabolic syndrome may be enhanced by recommendations to adopt the. DASH dietary pattern. ( ...