Fatty Acid Elevation for Obesity
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Yale University
Must not be taking: Steroids, Metabolism-altering drugs
Disqualifiers: Hepatic, Renal, Neurologic, Psychiatric, others
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial involves giving healthy individuals either a fat solution or a saltwater solution to see how it affects their brain's ability to transport glucose. The study focuses on non-diabetic, normal weight people to understand how sudden increases in blood fatty acids impact brain energy use. Researchers hope to learn more about brain glucose transport in relation to obesity.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications, vitamins, or supplements that can alter brain metabolism or lipids to participate in this trial.
What data supports the effectiveness of the treatment Intralipid 20% for obesity?
The research shows that Intralipid 20% is effective in providing essential fatty acids and maintaining nitrogen balance, which are important for overall health. However, there is no direct evidence from the studies provided that supports its effectiveness specifically for treating obesity.
12345Is the treatment generally safe for humans?
Intralipid, a type of intravenous fat emulsion, has been used safely in various medical settings. Studies show it does not cause significant heart-related side effects, even in patients with heart conditions, and is well tolerated without adverse effects in clinical trials.
12678How is the treatment Intralipid 20% IV Fat Emulsion unique for obesity?
Intralipid 20% IV Fat Emulsion is unique for obesity as it involves intravenous administration of a fat emulsion, which increases free fatty acid levels in the blood, potentially affecting blood pressure and endothelial function. This approach is different from typical oral medications or lifestyle interventions for obesity.
19101112Eligibility Criteria
This trial is for adults aged 18-45 with obesity (BMI >30 kg/m2) or normal weight (BMI 17-25 kg/m2), and HbA1C levels below 6.5%. Participants should not have significant health issues like liver, kidney, or heart diseases, uncontrolled high blood pressure, abnormal thyroid or clotting tests, recent drastic weight changes, substance abuse problems, or be pregnant/breastfeeding.Inclusion Criteria
HbA1C <6.5%
Normal weight individuals: BMI 17-25 kg/m^2
My BMI is over 30.
Exclusion Criteria
Triglycerides >200 mg/dL
My high blood pressure is not under control.
Abnormal PT/PTT/INR
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive an infusion of either Intralipid or normal saline for 12 hours
12 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1-2 weeks
Participant Groups
The study aims to understand how brain glucose transport is affected in obese individuals by temporarily raising fatty acid levels using Intralipid. A placebo group will serve as a comparison. The effects on brain metabolism are monitored through magnetic resonance spectroscopy (MRS).
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Non-diabetic, normal weight individuals receiving IntralipidExperimental Treatment1 Intervention
Non-diabetic, normal weight individuals receiving Intralipid. Participants will receive an infusion of Intralipid 20% for 12 hours through an IV (prior to and during scan #2)
Group II: Non-diabetic, normal weight individuals receiving salinePlacebo Group1 Intervention
Non-diabetic, normal weight individuals receiving saline. Participants will receive an infusion of normal saline (1:1 randomization) at 30 ml/hr for 12 hours through an IV (prior to and during scan #2
Intralipid, 20% Intravenous Emulsion is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Intralipid 20% for:
- Parenteral nutrition
- Caloric supplementation
🇪🇺 Approved in European Union as Intralipid 20% for:
- Parenteral nutrition
- Caloric supplementation
🇨🇦 Approved in Canada as Intralipid 20% for:
- Parenteral nutrition
- Caloric supplementation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Biomedical Research Imaging Center Marsico Hall (UNC)Chapel Hill, NC
Yale School of MedicineNew Haven, CT
University of North Carolina at Chapel HillChapel Hill, NC
Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)Chapel Hill, NC
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
University of North Carolina, Chapel HillLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Comparison of Intralipid 10% and Intralipid 20% as a source of energy and essential fatty acids--a multicenter study. [2013]A multicenter clinical study was done which directly compared efficacy and safety of Intralipid 10% and Intralipid 20%. Twenty-nine patients received the 10% concentration, 30 patients received the 20% concentration. Both groups of patients received equivalent amounts of calories, amino acids, dextrose and fat for seven day study periods. Analysis of nitrogen balance data showed that the two preparations were equally effective in maintaining nitrogen balance. Both concentrations of fat emulsion were effective in reversing or correcting the changes of essential fatty acid deficiency. Analysis of clinical laboratory data indicated that both preparations were equally well tolerated by the patients. No adverse effects attributed to the fat emulsions were observed.
[Differences in the elimination of intravenously administered intralipid and lipofundin S]. [2013]Intravenous infusions of fat emulsions in different doses were performed using human volunteers. With both the dosages 0.1 gm/kg b.w. h and 0.25 gm/kg b.w. h) the elimination of intralipid was less effective than that of lipofundin S. During intralipid, therefore, significantly higher blood concentrations for triglycerides were attained. It is concluded, that different guidelines for the dosage of intravenous fat should be given. The kind of the preparation, e.e. the physical status of the fat particles and not merely the chemical composition, are obviously influencing the metabolic handling of intravenous fat. A strong monitoring of the patients triglyceride concentration during intravenous fat is recommended. An steady increase in serum triglyceride concentration or a significant lipemia should be an indication for the termination of the fat infusion.
Review of Intravenous Lipid Emulsion Therapy. [2018]Intravenous fat emulsion (IVFE) is an important source of calories and essential fatty acids for patients receiving parenteral nutrition (PN). Administered as an individual infusion or combined with PN, the fats provided by IVFE are vital for cellular structural function and metabolism. The affinity of some medications to lipids has led to the use of IVFE as a treatment for any lipophilic drug overdose. This article will explain the available formulations of IVFE, administration, and maintenance issues, as well as the risks and benefits for various applications.
Structured triglyceride emulsions in parenteral nutrition. [2017]Over the past 3 decades, various concepts for IV fat emulsions (IVFE) have been developed. A randomized, structured-lipid emulsion based on an old technology has recently become available. This structured-lipid emulsion is produced by mixing medium-chain triglycerides and long-chain triglycerides, then allowing hydrolysis to form free fatty acids, followed by random transesterification of the fatty acids into mixed triglyceride molecules. Studies in animals have shown an improvement in nitrogen balance with the use of these lipid emulsions. Only 8 human clinical studies with these products have been performed. The results of these human clinical studies have been less promising than the animal studies; however, an improvement in nitrogen balance and lipid metabolism exceeds results associated with infusion of long-chain triglycerides (LCT) or a physical mixture of long-chain triglycerides and medium-chain triglycerides (LCT-MCT). Structured-lipid emulsion seems to induce less elevation in serum liver function values compared with standard IVFEs. In addition, structured-lipid emulsions have no detrimental effect on the reticuloendothelial system. Further studies are necessary in order to recommend the use of structured-lipid emulsions. The clinical community hopes that chemically defined structured triglycerides will make it possible to determine the distribution of specific fatty acids on a specific position on the glycerol core and therefore obtain specific activity for a specific clinical situation.
A new alternative for intravenous lipid emulsion 20% w/w from superolein oil and its effect on lipid and liver profiles in an animal model. [2020]Intravenous lipid emulsion (IVLE) was first used to prevent essential fatty acids deficiency. IVLE with α-tocopherol was reported to provide protection against parenteral nutrition-associated liver disease. This study aims to determine the optimal parameters and conditions in developing a physically stable IVLE from superolein palm oil (SoLE 20%) and its effect on lipid and liver profiles in an animal model.
Successful exchange transfusion in extremely preterm infant after symptomatic lipid overdose. [2018]Complications of intravenous lipid administration are relatively uncommon. However, inadvertent rapid infusion of intravenous fat emulsion (IVFE) is an inherent risk when fats are infused separately from the dextrose-amino acid solution.
Hemodynamic effects of intravenous fat emulsions in patients with heart disease. [2023]Two intravenous fat emulsions (Liposyn 10%, Abbott Laboratories, North Chicago, IL, and Intralipid 10%, Cutter Laboratories, Berkeley, CA) were evaluated in 13 adult patients following cardiopulmonary bypass procedures in a randomized, prospective, double-blind study to determine their overall hemodynamic effects. The fat emulsions were administered for 30 minutes, and each patient was his own control. Neither intravenous fat emulsion was observed to exert significant changes in left ventricular stroke work, left ventricular filling pressure, cardiac output, systemic vascular resistance, mean systemic arterial blood pressure, central venous pressure, or mean pulmonary artery pressure. This study confirmed that the administration of 10% fat emulsions available in the United States does not exert significant untoward hemodynamic changes, even in patients with severe cardiac impairment recovering from recent open heart surgery.
Lipid Emulsion, More Than Reversing Bupivacaine Cardiotoxicity: Potential Organ Protection. [2018]Efforts to develop a treatment for bupivacaine cardiotoxicity led to the discovery that Intralipid, a popular brand of intravenous lipid emulsion, could be used not only as an effective treatment for anesthetic-induced cardiac arrest, but also as a means of reversing many other toxicities. Contradictory data exist regarding the mechanism of action of lipid emulsion, a combination of fatty acids traditionally used in parenteral nutrition. Some researchers attribute the effects to lipophilicity and the individual characteristics of the lipids, while other data demonstrate a direct empowering mechanism through cellular upstream and downstream pathways. Understanding the underlying mechanism of action of this safe source of calories may assist in the development of novel organ protective agents. In this review, some of the direct cardiac effects of lipid emulsion are briefly discussed. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.
Vascular effects of intravenous intralipid and dextrose infusions in obese subjects. [2022]Hyperglycemia and elevated free fatty acids (FFA) are implicated in the development of endothelial dysfunction. Infusion of soy-bean oil-based lipid emulsion (Intralipid®) increases FFA levels and results in elevation of blood pressure (BP) and endothelial dysfunction in obese healthy subjects. The effects of combined hyperglycemia and high FFA on BP, endothelial function and carbohydrate metabolism are not known. Twelve obese healthy subjects received four random, 8-h IV infusions of saline, Intralipid 40 mL/h, Dextrose 10% 40 mL/h, or combined Intralipid and dextrose. Plasma levels of FFA increased by 1.03±0.34 mmol/L (p=0.009) after Intralipid, but FFAs remained unchanged during saline, dextrose, and combined Intralipid and dextrose infusion. Plasma glucose and insulin concentrations significantly increased after dextrose and combined Intralipid and dextrose (all, p
The passage of fat emulsion across the human placenta. [2019]Six patients near term were given an intravenous infusion of a fat emulsion (Intralipid) a few hours before normal delivery or Caesarean section. Six other non-infused patients were studied as controls. Maternal venous and umbilical venous and arterial blood samples were taken at delivery and analyzed for individual fatty acid concentrations in triglyceride, free fatty acid (FFA) and phospholipid fractions. The emulsion, being rich in oleic and linoleic acids, affected the composition of the maternal triglycerides. The fetal lipids were also altered and the infusions resulted in large positive umbilical venous-arterial (v-a) differences in FFA and triglyceride fatty acid concentrations, but this was not the case for phospholipid concentrations. The fatty acids with the largest v-a differences were those prominent in the emulsion.
Influence of different intravenous lipid emulsions on fatty acid status and laboratory and clinical outcomes in adult patients receiving home parenteral nutrition: A systematic review. [2019]Intravenous lipid emulsions (IVLEs) are a key component in long-term home parenteral nutrition (HPN), providing energy and essential fatty acids (EFAs). Modification of the fatty acid (FA) composition of IVLEs may lead to changes in metabolic responses and cell and tissue function, providing opportunity for clinical improvements. Studies have suggested that, in place of conventional pure soybean oil (SO)-based IVLEs, which have a high omega-6 FA content, alternative IVLEs with different FA profiles may have beneficial effects. Our aim is to assess the effects of different IVLEs in adults dependent on HPN.
Emergence of Mixed-Oil Fat Emulsions for Use in Parenteral Nutrition. [2019]Since early work by Wretlind and Schuberth led to the development of a stable and safe intravenous fat emulsion (IFE) using soybean oil (SO) and egg phospholipid emulsifier, IFEs have become a crucial source of essential fatty acids and nonprotein energy in parenteral nutrition. However, largely due to their high ω-6 polyunsaturated fatty acid (PUFA) and phytosterol content, SO IFEs have been associated with complications, including a proinflammatory profile and hypertriglyceridemia, as well as intestinal failure-associated liver disease. Subsequent generations of IFEs have used other sources of triglycerides, including medium-chain triglycerides (MCTs), olive oil (OO), and fish oil (FO), to reduce the SO component. Although these IFEs showed some improvement in complications compared with SO IFE, the quest to develop an IFE with a better side effect profile and beneficial physiologic effects led to the development of a mixed-oil (MO) IFE (Smoflipid; 30% SO, 30% MCTs, 25% OO, and 15% FO) that was recently approved by the Food and Drug Administration. The use of a MO approach is theoretically and intuitively more physiologically similar to normal dietary human consumption. Although the data are from small, short-term trials, MO IFE results thus far have been promising, with some studies showing improved liver function tests, improvement in triglycerides, higher ω-3/ω-6 PUFA ratio, and higher α-tocopherol. Larger long-term studies are needed to ensure these theoretical benefits lead to significant improvement in clinical outcomes.