TLC Dietary intervention for Dietary Modifications

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cleveland Clinic, Cleveland, OH
Dietary Modifications+1 More
TLC Dietary intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a diet change may help reduce the risk of heart disease.

See full description

Eligible Conditions

  • Dietary Modifications
  • Cardiovascular Risk

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether TLC Dietary intervention will improve 1 primary outcome in patients with Dietary Modifications. Measurement will happen over the course of From baseline to 12 weeks follow-up.

Week 12
Change in TMAO level

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

MeLT Dietary intervention
1 of 3
TLC Dietary intervention
1 of 3
MeLT dietary intervention with TMAO
1 of 3
Experimental Treatment

This trial requires 100 total participants across 3 different treatment groups

This trial involves 3 different treatments. TLC Dietary Intervention is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

MeLT Dietary intervention
Behavioral
Mediterranean Low-TMAO (MeLT) diet
TLC Dietary intervention
Behavioral
Therapeutic Lifestyle Changes (TLC) diet
MeLT dietary intervention with TMAO
Behavioral
Mediterranean Low TMAO diet with TMAO levels reported

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to 12 weeks follow-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline to 12 weeks follow-up for reporting.

Who is running the study

Principal Investigator
W. T.
Wilson Tang, Staff Cellular and Molecular Medicine and Cardiovascular Medicine
The Cleveland Clinic

Closest Location

Cleveland Clinic - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Men and women age 18 years or above.
Elevated TMAO metabolizers (>5 µM) based on screening test.
Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting study and staying on the same aspirin regimen during the duration of the 12-week study.
Willing to sign consent form or to follow study protocol, which includes 12-week dietary modification.

Patient Q&A Section

Is tlc dietary intervention safe for people?

"A short (<6-week) low-fat dietary intervention, consisting of increasing vegetables as a whole rather than decreasing fat from the diet, resulted in increases in fat mass in a cohort of overweight men and women." - Anonymous Online Contributor

Unverified Answer

Does dietary modifications run in families?

"Data from a recent study of this study have demonstrated that dietary modification run in families, and highlight the important influence of family environmental factors on health outcomes." - Anonymous Online Contributor

Unverified Answer

How many people get dietary modifications a year in the United States?

"More than 4 million US adults meet dietary guidelines each year. About 1.5 million meet dietary guidelines for cholesterol, 1.3--1.4 million meet guidelines for saturated fatty acids, and 1.5--1.7 million Americans meet recommendations for dietary fiber and micronutrients. Recommendations for improving the diet, especially for cholesterol and saturated fatty acids, are warranted." - Anonymous Online Contributor

Unverified Answer

What causes dietary modifications?

"In the majority of the cases, the cause of dietary modifications may be difficult to identify. They vary according to the patient, the dietician and the medical status of the patient. Most are due to fear of developing another illness, or to search for a healthier lifestyle. A diet that is compatible with the patient's medical status and lifestyle may provide the best result." - Anonymous Online Contributor

Unverified Answer

What is dietary modifications?

"Dietary treatment can prevent the onset or retard the progression of many chronic diseases. Dietary modification is a low-cost and readily practical method of improving a person's health." - Anonymous Online Contributor

Unverified Answer

Can dietary modifications be cured?

"Dietary modifications appear likely to be of no use in the management of type 2 diabetes. It may be possible to encourage dieters to reduce fat intake by replacing it with more lean meats and fats, however the evidence base for this approach needs to be strengthened." - Anonymous Online Contributor

Unverified Answer

What are the signs of dietary modifications?

"The number of signs of dietary changes is higher in long-term than short-term patients. The most common signs of dietary changes are dietary information, taste changes and poor intake of water. The number of signs of poor diet was higher in the long-term group." - Anonymous Online Contributor

Unverified Answer

What are common treatments for dietary modifications?

"In a recent study, findings do not support dietary changes as a first line treatment for diabetes. The majority of diabetes experts support diet therapy as a good first line, short term treatment for patients without health insurance." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in tlc dietary intervention for therapeutic use?

"TLC dietary interventions have a long history in treating various conditions but the most effective tlcs for use in therapeutic modalities is yet to be identified." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for dietary modifications?

"Dietary modification is a promising intervention that may offer a viable option for patients with both chronic and aggressive gastrointestinal neoplasms. It is now warranted for us to investigate the results of such studies with different diets in larger trials with long-term follow-up." - Anonymous Online Contributor

Unverified Answer

How serious can dietary modifications be?

"Although dietetic advice has been reported to improve survival, as many as 50% of people treated for cancer are known to have poor nutrition at diagnosis, and it seems that even those who receive treatment are still at risk of malnutrition. The evidence we report here suggests that nutritional intervention may have no effect on survival for people with cancer but improves nutritional status in some, most likely those with more advanced cancer." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating dietary modifications?

"There are several therapeutic options that may decrease cholesterol and LDL (bad) levels or increase HDL (good) levels. These include statins, fibrates or resveratrol, lovastatin, ketogenic oil therapy and resveratrol. However, these are not yet established treatments and are currently being used off-label. In the future, it is likely that more therapeutics will be explored for treating lipid disorders." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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