Meal Macronutrients for Blood Fat Levels
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how different types of meals (meal macronutrients) affect blood fat levels, which is important for conditions like heart disease. Researchers are focusing on individuals with varying body fat levels and a kidney problem called nephrotic syndrome. Participants will consume meals with different nutrient balances during two clinic visits, and researchers will test their blood to observe the effects. Individuals with a health condition affecting fat metabolism or healthy volunteers might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are taking medications or supplements that might interfere with the study data, the investigator may ask you to stop.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that different nutrients, such as fats, carbohydrates, and proteins, can affect blood fat levels. High-fat diets, particularly those rich in saturated fats, can raise cholesterol, a risk factor for heart disease. High-carbohydrate diets can also alter blood fat levels, but in different ways. This study examines how these nutrient differences impact individuals with varying body fat levels and kidney issues, such as nephrotic syndrome.
The trial investigates how the body processes meals with different nutrient levels. Testing involves simple procedures like blood tests and scans to measure body fat and metabolism, which are safe and routine.
The study is in an early phase, focusing on how well participants tolerate these meal variations. The information provided reports no serious side effects. Since these are regular meals with different nutrient focuses, they are likely to be well-tolerated by participants.12345Why are researchers excited about this trial?
Researchers are excited about exploring meal macronutrients for managing blood fat levels because this approach focuses on dietary components rather than medication. Unlike standard treatments that often involve drugs like statins, which lower cholesterol by targeting enzyme activity in the liver, adjusting macronutrient intake aims to naturally influence blood fat levels through diet. This method could offer a more holistic and sustainable way to manage blood fat, potentially reducing the need for pharmaceuticals and their associated side effects. Additionally, the personalized nature of dietary interventions could cater to individual health needs, making it a promising area of study.
What evidence suggests that this trial's treatments could be effective for managing blood fat levels?
Research has shown that the nutrients in meals can significantly impact blood fat levels. Studies have found that diets with a moderate amount of fat reduce triglycerides (a type of fat in the blood) more effectively than low-fat diets. One study discovered that consuming high-quality nutrients, such as healthy fats and proteins, is linked to a lower risk of high blood fat levels. While low-carbohydrate diets can aid weight loss, they might also raise LDL (bad cholesterol) and total cholesterol levels. These findings suggest that balancing fats and carbohydrates in meals is crucial for managing blood fat levels, especially for individuals with health issues related to fat processing. Participants in this trial will explore how different meal macronutrient compositions affect blood fat levels.16789
Who Is on the Research Team?
Rebecca J Brown, M.D.
Principal Investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Are You a Good Fit for This Trial?
This trial is for adults over 18 with conditions affecting body fat handling, like nephrotic syndrome or diabetes, and healthy individuals. Participants should have normal liver function tests, a BMI of at least 18.5 but less than 25 (or less than 23 for Asian descent), not drink excessively, and not be on interfering meds.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants will have 2 overnight stays in the clinic within 6 months, consuming meals with different macronutrient compositions and undergoing various tests.
Optional Extension
Participants may opt to have a third visit where the breakfast will be high in protein.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Meal Macronutrients
Trial Overview
The study examines how high-fat, high-carbohydrate, and optionally high-protein breakfasts affect blood fat levels in participants with varying health statuses related to body fat. It involves overnight clinic stays with multiple blood draws after eating the meals to measure changes in lipid profiles.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Nephrotic syndrome
Metabolic syndrome
Lipodystrophy
Healthy
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor
Citations
Effects of Dietary Macronutrients on Plasma Lipid Levels ...
This review aims to examine the effects of different macronutrient compositions on lipid markers, thus providing insight into the potential roles of various ...
Effects of carbohydrate-restricted diets and macronutrient ...
Moderate-carbohydrate diets offered balanced benefits, whereas ketogenic diets produced greater weight loss but greater increases in LDL and total cholesterol.
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consultant360.com
consultant360.com/article/consultant360/impact-different-dietary-patterns-blood-lipid-levels-patients-and-withoutImpact of Different Dietary Patterns on Blood Lipid Levels ...
The evidence implies that, compared with low-fat diets, moderate-fat diets may more effectively lower triglyceride levels, triglycerides:HDL-C ratio, non-HDL-C, ...
Associations between dietary macronutrient quality and odds ...
Our findings suggested that intake of high-quality macronutrients was associated with reduced odds of hyperlipidemia.
The Effect of Diet on Cardiovascular Disease and Lipid ... - NCBI
The fat advice group reduced SFA from 15% to 11% of total calories, increased PUFA from 7% to 9%, and increased carbohydrate intake from 44% to ...
Nutrition & Health Info Sheets for Health Professionals
cholesterol levels above 240 mg/dL are associated with high risk. Eating between 25 and 35 percent of total daily calories as fats from foods like fish, nuts ...
Saturated Fat
The American Heart Association recommends limiting saturated fats to less than 6% of total calories. Saturated fats are found in butter, cheese, red meat, ...
How to Understand and Use the Nutrition Facts Label
Learn how to understand and use the Nutrition Facts Label to make informed food choices that contribute to a healthy diet.
Macronutrients & Cardiovascular Diseases: A Review
This narrative review explores the relationship between macronutrient intake and CVD risk, focusing on carbohydrates, proteins, and fats.
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