What side effects are associated with this type of intervention?

Common treatments for inflammation often include dietary modifications such as reducing sodium and fructose intake. High sodium intake is associated with increased blood pressure and potential cardiovascular issues. Excessive fructose consumption can lead to metabolic disturbances, including insulin resistance and increased uric acid levels, which may exacerbate conditions like gout. Other dietary patterns, such as the Mediterranean diet, have been shown to reduce inflammation markers like C-reactive protein (CRP) but generally have fewer adverse effects. However, any significant dietary change should be monitored by a healthcare provider to ensure it meets individual health needs.

What prior FDA approvals exist?

The FDA has approved various drugs for the treatment of inflammation, including nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, corticosteroids such as prednisone, and biologics like adalimumab and infliximab. While these treatments are not specifically related to dietary sodium and fructose, they are commonly used to manage inflammation. Dietary modifications, such as reducing sodium and fructose intake, are also recommended to help manage inflammation and related conditions like hypertension.

What other types of research exist?

Promising, novel alternatives to dietary sodium and fructose for managing inflammation include increasing dietary fiber intake and omega-3 fatty acids. These components have shown potential in reducing inflammation and improving health outcomes.

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Dietary Supplement

Sodium and Fructose Diet for High Blood Pressure

N/A

Recruiting

Led By Ronald K McMillan, M.S

Research Sponsored by University of Delaware

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

normal blood pressure

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7 of diet intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how eating more salt and fructose affects blood pressure and inflammation in young healthy adults. The researchers aim to see if fructose makes people more sensitive to salt, leading to higher blood pressure and inflammation. Understanding these effects can help determine cardiovascular risk in people with normal blood pressure.

Who is the study for?

This trial is for young, healthy adults with normal blood pressure. It's open to all genders and ethnic groups. The study aims to understand how different diets affect blood pressure and inflammation.

What is being tested?

The study is testing three diets: one with recommended sodium levels and low fructose, another with high sodium but low fructose, and a third combining high sodium with high fructose to see their effects on blood pressure and inflammation.

What are the potential side effects?

While the trial involves dietary changes rather than medication, potential side effects may include fluctuations in blood pressure or inflammatory responses depending on individual sensitivity to sodium and fructose intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My blood pressure is within the normal range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7 of diet intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7 of diet intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 of diet intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24-hour Blood Pressure

Inflammatory cytokines

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3. High sodium and high fructose dietExperimental Treatment2 Interventions

7 day consumption of high fructose drink (200g) and recommended sodium (2300 mg)from whole food while consuming high sodium pills from pills (3400 mg)

Group II: Arm 2. High sodium and low fructose dietExperimental Treatment2 Interventions

7 day consumption of low fructose drink (20g) and recommended sodium (2300 mg) from whole food while consuming high sodium from pills (3400 mg)

Group III: Arm 1. Recommended sodium and low fructose dietExperimental Treatment2 Interventions

7 day consumption of low fructose drink (20g) and recommended sodium (2300mg) from whole food while consuming placebo from pills

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for inflammation often target dietary factors, such as reducing sodium and fructose intake. High sodium levels can increase blood pressure and promote inflammation by activating immune cells and increasing oxidative stress. Fructose, particularly in high amounts, can lead to metabolic disturbances that exacerbate inflammation through increased production of uric acid and inflammatory cytokines. By managing these dietary components, patients can potentially reduce inflammation and its associated risks. Understanding these mechanisms is crucial for patients as it highlights the importance of dietary choices in managing inflammation and improving overall health.