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Olive Oil, Refined

This article discusses clinical trials investigating the use of refined olive oil as a component in parenteral nutrition formulations. These studies aim to evaluate the effectiveness and safety of parenteral nutrition products containing olive oil for patients undergoing major abdominal surgeries or those requiring nutritional support. The trials focus on comparing different nutrition methods and their impact on patient outcomes, including muscle wasting, postoperative complications, and quality of life.

Table of Contents

What is Olive Oil, Refined?

Olive oil, refined is a key component used in parenteral nutrition formulations. Parenteral nutrition is a method of providing nutrition directly into the bloodstream when a patient cannot eat or absorb nutrients through their digestive system[1]. In medical settings, refined olive oil is used as part of a carefully balanced mixture of nutrients, including fats, proteins, carbohydrates, vitamins, and minerals.

Medical Uses

Refined olive oil is primarily used in parenteral nutrition products for patients who cannot receive nutrition through normal eating or tube feeding. These situations may include:

  • Patients recovering from major abdominal surgeries, such as oesophagectomy (surgical removal of part or all of the esophagus)[2]
  • Individuals with severe gastrointestinal disorders
  • Patients in intensive care units who cannot eat normally
  • People with conditions that impair nutrient absorption in the gut

Composition and Formulation

Refined olive oil is typically part of a complex parenteral nutrition formulation. In the products mentioned in the clinical trials, it is combined with other ingredients to create a balanced nutritional emulsion. Some key components include:

  • Amino acids: Such as valine, alanine, arginine, and others, which are the building blocks of proteins
  • Other oils: Including soya-bean oil refined, medium-chain triglycerides, and fish oil rich in omega-3 acids
  • Electrolytes: Such as potassium chloride, calcium chloride, and sodium acetate
  • Carbohydrates: Usually in the form of glucose monohydrate
  • Vitamins and minerals: Including zinc sulphate heptahydrate

This combination provides a balanced source of calories, essential fatty acids, and other nutrients necessary for patients who cannot eat normally[1].

Administration

Parenteral nutrition products containing refined olive oil are typically administered through intravenous infusion. This means they are delivered directly into the bloodstream through a vein. The exact dosage and administration schedule depend on the patient’s individual needs and medical condition[1][2].

Clinical Trials and Research

Several clinical trials are investigating the use of parenteral nutrition products containing refined olive oil:

  1. EATERS Trial: This study is comparing early versus delayed supplementary parenteral nutrition after major emergency abdominal surgery. It aims to determine how the timing of parenteral nutrition affects the risk of postoperative infections and other complications[1].
  2. Oesophagectomy Nutrition Study: This trial is investigating how different routes of nutrition (including parenteral nutrition) impact muscle wasting and other outcomes in patients recovering from oesophageal surgery[2].

Potential Benefits

The use of refined olive oil in parenteral nutrition may offer several potential benefits:

  • Provides essential fatty acids and calories
  • May help prevent malnutrition in critically ill patients
  • Could potentially reduce the risk of infections and other complications after surgery
  • Might help maintain muscle mass in patients who cannot eat normally

However, it’s important to note that these potential benefits are still being studied in clinical trials[1][2].

Considerations and Precautions

While parenteral nutrition products containing refined olive oil can be life-saving for some patients, they should only be used under close medical supervision. Some important considerations include:

  • These products are not suitable for everyone. For example, they may not be appropriate for pregnant or breastfeeding women, or people with certain medical conditions[1].
  • The use of parenteral nutrition requires careful monitoring by healthcare professionals to ensure proper dosing and to watch for any potential complications.
  • These products are typically used only when a patient cannot receive nutrition through other means, such as normal eating or tube feeding.

As with any medical treatment, the use of parenteral nutrition products containing refined olive oil should be discussed thoroughly with a healthcare provider to weigh the potential benefits and risks for each individual patient.

Aspect Details
Study Types Randomized, controlled trials
Main Product SmofKabiven (parenteral nutrition emulsion)
Key Ingredients Refined olive oil, soybean oil, medium-chain triglycerides, fish oil, amino acids, electrolytes, glucose
Patient Groups Adults undergoing major emergency abdominal surgery or elective esophagectomy
Primary Outcomes Postoperative infections, muscle wasting
Secondary Outcomes Complications, mortality rates, quality of life, nutritional intake
Administration Route Intravenous infusion
Study Duration Up to 180 days post-surgery for follow-up

FAQ

  • What is the main purpose of these clinical trials? The main purpose of these clinical trials is to evaluate the effectiveness and safety of parenteral nutrition products containing refined olive oil for patients undergoing major abdominal surgeries or those requiring nutritional support.
  • What is SmofKabiven? SmofKabiven is a parenteral nutrition product that contains a combination of nutrients, including refined olive oil, soybean oil, medium-chain triglycerides, and fish oil rich in omega-3 acids, along with various amino acids, electrolytes, and glucose.
  • How is refined olive oil used in these clinical trials? Refined olive oil is used as one of the components in the parenteral nutrition formulations being studied. It is combined with other oils and nutrients to provide a balanced nutritional solution for patients who cannot receive nutrition through regular eating.
  • What are some of the main outcomes being measured in these trials? The trials are measuring outcomes such as the rate of postoperative infections, muscle wasting after surgery, postoperative complications, quality of life, and mortality rates at different time points (30, 90, and 180 days after surgery).
  • Who are the typical participants in these clinical trials? Typical participants include adults (18 years or older) undergoing major emergency abdominal surgeries or elective esophagectomies. The trials have specific inclusion and exclusion criteria to ensure appropriate patient selection.

Ongoing Clinical Trials on Olive Oil, Refined

  • Study on Nutrition Methods and Muscle Loss After Esophagectomy Using SmofKabiven and Drug Combination for Patients Recovering from Esophageal Surgery

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Parenteral Nutrition: A method of feeding that bypasses the gastrointestinal tract and provides nutrients directly into the bloodstream through a vein.
  • SmofKabiven: A brand name for a parenteral nutrition product that contains a mixture of fats, amino acids, electrolytes, and glucose for intravenous feeding.
  • Esophagectomy: A surgical procedure to remove part or all of the esophagus, typically performed to treat esophageal cancer.
  • Cachexia: A complex metabolic syndrome associated with underlying illness and characterized by loss of muscle with or without loss of fat mass.
  • Laparotomy: A surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity.
  • Enteral Nutrition: A method of feeding that uses the gastrointestinal tract to deliver nutrition, typically through a tube.
  • TPN: Total Parenteral Nutrition, a method of feeding that bypasses the gastrointestinal tract completely.
  • CT-scan: Computed Tomography scan, an imaging method that uses X-rays to create detailed cross-sectional images of the body.
  • NRS-2002: Nutritional Risk Screening 2002, a tool used to identify patients at nutritional risk.
  • Nosocomial Infections: Infections that are acquired in a hospital or other healthcare facility, not present or incubating at the time of admission.

References

  1. http://clinicaltrials.eu/trial/study-on-early-vs-delayed-supplementary-parenteral-nutrition-with-smofkabiven-for-patients-after-major-emergency-abdominal-surgery/
  2. http://clinicaltrials.eu/trial/study-on-nutrition-methods-and-muscle-loss-after-esophagectomy-using-smofkabiven-and-drug-combination-for-patients-recovering-from-esophageal-surgery/