Nutritional and Metabolic Diseases

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Digestive System Diseases

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Other Dietary Supplements

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Amino Acids

Omega 3 Fatty Acid

Alanine

Glutamine

an isocaloric and iso-nitrogenous standard parenteral nutrition (Kabiven)

alanine-glutamine (aln-gln) (Dipeptiven) supplemented parenteral nutrition (S-D group, n=8),

Omega-3 fatty acid (Omegaven) supplemented parenteral nutrition (S-O group, n=8)

ala-gln and omega 3 fatty ascid supplemented parenteral nutrition (S-D-O group, n=10).

Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Standard (Kabiven)

Parenteral nutrition (Kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. it was 0.3-0.4 g/kg/day for glutamine dipeptide (Dipeptiven) supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Standard-Glutamine

Parenteral nutrition (Kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid (omegaven)supplementation was 0.1-0.2 g/kg /day. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Standard-Omega 3 fatty acid

Parenteral nutrition (kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid (omegaven) supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide (dipeptiven)supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Standard-glutamine-omega 3

Mustafa Dulger, Professor

Hypercatabolism and immune suppression are frequently seen in patients with malignancy. Preoperative nutritional state is an important factor in determining surgical and postoperative complications because the preoperative nutritional status affects the postoperative nutritional state, immunity and inflammatory response. In these patients, standard parenteral nutrition may not be sufficient to maintain the immunity and provide positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa. There is a report which showed that glutamine dipeptide supplemented parenteral nutrition improved the cellular and humoral immune functions. The investigators aimed to evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral nutrition on the neutrophil functions and postoperative course of patients with colorectal cancer.

Purpose Hypercatabolism and immune suppression are frequently seen in patients with malignancy.Preoperative nutritional state is an important factor in determining surgical and postoperative complications because the preoperative nutritional status affects the postoperative nutritional state, immunity and inflammatory response.In these patients, standard parenteral nutrition may not be sufficient to maintain the immunity and provide positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa.There is a report which showed that glutamine dipeptide supplemented parenteral nutrition improved the cellular and humoral immune functions. The investigators aimed to evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral nutrition on the neutrophil functions and postoperative course of patients with colorectal cancer.

Condition Intervention Phase Malnutrition Colorectal Cancer Dietary Supplement: Immunonutrition Phase 4

Study Type: Interventional Study Design: Prevention, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, N/A

Official Title: Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And Length Of Stay-A Double Blind,Controlled, Randomized Study

Primary Outcome Measure: Title: neutrophil functions Time Frame: perioperative,postoperative third and seventh days for change in first seven days of hospital stay Description: For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.

Secondary Outcome Measures: Title: Length of stay Time Frame: Length of stay (participants will be followed for the duration of hospital stay) for colorectal cancer patients which are eligable for study study from january 2007 to january 2008 in one year period.

Description: For comparison of four different nutrition on length of stay (participants will be followed for the duration of hospital stay)

Actual Enrollment: 36 Study Start Date: January 2007 Actual Study Completion Date: January 2008 Actual Primary Completion Date: January 2008

Arms Assigned Interventions Active Comparator: Control an isocaloric and iso-nitrogenous standard parenteral nutrition

Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Experimental: Standard parenteral-glutamine (S-D) alanine-glutamine (aln-gln) (Dipeptiven) supplemented parenteral nutrition (S-D group, n=8),

Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Experimental: Standard-Omega-3 fatty acid (S-O) Omega-3 fatty acid (Omegaven) supplemented parenteral nutrition (S-O group, n=8)

Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Experimental: Standard-glutamine-omega 3 (S-D-O) ala-gln and omega 3 fatty ascid supplemented parenteral nutrition (S-D-O group, n=10).

Dietary Supplement: Immunonutrition Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Nutrition for Colorectal Cancer Patients and Neutrophil Functions

Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And Length Of Stay-A Double Blind,Controlled, Randomized Study

For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.

For comparison of four different nutrition on length of stay (participants will be followed for the duration of hospital stay)

Kocaeli University

Professor in Surgical Oncology and head of Nutrition Team

Arginine

40 patients will be instructed to consume 600 ml of the special "immune-enhancing" formula plus 20 g glutamine (Supportan R + Glutamine plus R, which contain 900 Kcal and 60 g protein/day, with 24.4 g glutamine, 2,2 g arginine and 4.4 g of omega 3 fatty acids, in a lower volume due to its higher energy density).

40 patients that do not agree to participate, do not have enough time before the operation, do not tolerate the product and/or drink less than 100 cc/day.

600 ML OF AN ENERGY DENSE DRINK PLUS 20 G GLUTAMINE POWDER (to give 900 Kcal and 80 g protein/day)

SUPPORTAN + GLUTAMINE PLUS

Patients will be assessed and followed, but will receive no special nutritional support before the surgical procedure

NO PREOPERATIVE NUTRITION SUPPORT

María Pía de la Maza, M.D.

Daniel C. Bunout, M.D.

After surgical treatment, numerous trials using early postoperative enteral or parenteral nutritional support have been attempted, in order to reduce morbidity and mortality. Although it is difficult to compare among heterogeneous interventions, most of them have not been successful, a fact generally attributed to the timing of the intervention. On the other hand, nutrients that become "conditionally essential" under certain stressful circumstances, the so called nutraceuticals, have been incorporated into nutritional formulations. Both facts have prompted the idea of pre or perioperative nutrition support, using specific formulations called "immune enhancing" formulas, containing arginine, nucleotides, glutamine and omega3 fatty acids in varying concentrations. The provision of these nutraceuticals prior and early after the surgical, and particularly in oncologic surgery, theoretically permits to obtain adequate circulating and tissue concentrations for the moment when they are most needed. Exclusive postoperative provision of these substances would not be able to replenish depots and provide them for an adequate immune response and wound healing after surgery. However, regarding the preoperative approach, it is still not know which patients benefit more (less or more severely malnourished), which specific nutrient(s) are responsible for the positive effects, and the precise timing these nutrients should be provided. The present study aims to demonstrate that immune-enhancing formulas are superior to standard enteral products in reducing postoperative nutrition-related complications.

HYPOTHESIS:

Patients receiving enteral nutrition support with immune-enhancing formulas (containing higher concentrations of arginine, glutamine and omega 3 fatty acids compared with standard polymeric formulas) during 7 days before a major oncological surgical procedure, have a lower incidence of nutritional-related postoperative complications, compared with patients without preoperative nutritional supplementation or those supplemented with standard formulas.

OBJECTIVES:

* To put in practice a routine nutritional assessment for every patient that is going to be submitted to major digestive oncologic surgery
* In these patients evaluate adherence and tolerance of enteral drinks, comparing immune-enhancing with the standard polymeric formulations, during 7 days prior to surgery
* To compare frequency of postoperative nutrition-related complications (infections, anastomotic leaks and hospital length of stay), among non-supplemented patients and those receiving preoperative immune-enhancing or standard polymeric formulas.

PATIENTS AND METHODS:

Every patient proposed for major elective digestive oncologic surgery will be invited to a nutritional assessment. Exclusion criteria will be emergency surgery or renal failure (serum creatinine over 1.5 mg/dL). Some patients will not accept or will not be able to attend for several reasons, however they will be assessed by the clinical nutritionist the day of admission, before entering the OR, and followed as the other study patients, and will be considered the control group. Nutritional assessment will include clinical story, dietary recall, Global Subjective Assessment (GSA), calculation of percent weight loss respect habitual weight, anthropometric measurements (height, weight, body mass index) and hand grip strength. Functional involvement will be studied by the Karnofsky score. Among laboratory analysis total proteins, albumin, creatinine, BUN and blood cells for lymphocyte count will be included. All data will be registered in a special chart and then emptied in a computational data base.

After the nutritional assessment, both well nourished and undernourished patients will be instructed to consume an enteral drink, orally or by gastrostomy or enteral feeding tube, during 7 days before surgery. Seventy patients will receive 1 lt per day of a standard polymeric formula (Fresubin 22%, which gives 1000 Kcal and 35 g protein, does not contain free aminoacid nor omega fatty acids, and contains glutamine and arginine concentrations of milk proteins. In order to increase protein intake, 50 g /día of Proteinex R will be added in this group). The other 70 patients will be instructed to consume 600 ml of the special immune-enhancing formula plus 20 g glutamine (Supportan R + Glutamine plus R , which contain 900 Kcal and 60 g protein/day, with 24.4 g glutamine, 2,2 g arginine and 4.4 g of omega 3 fatty acids, in a lower volume due to its higher energy density). Both products are enriched with essential vitamins and minerals. The enteral formulas will be assigned through randomized computer-generated numbers, in an open way. Patients that do not agree to participate, do not have enough time before the operation, do not tolerate the product and drink less than 100 cc/day will be considered control subjects. The enteral products will be sold to the patients directly at the oncologic clinic, both the same prize, and lower to marketing prizes, due to the participation of Fresenius-Kabi in the protocol. However if the patients does not have the means, will receive it for free. All patients will be instructed to maintain their previous diet, adding the enteral supplement, or completing their requirement by tube feeding with standard or specific formulations (e.g. diabetic formulation).

All patients will be followed during the entire postoperative period, registering days of stay at the critical ward, time of mechanical ventilation, days of fever, infections (wound, intra-abdominal, pulmonary, urinary, etc), anastomotic leaks and time of hospitalization.

The participation of Fresenius-Kabi will consist of:

* Paying the enteral formulas, thus avoiding payment for patients (considering that Fundación Arturo Lopez Perez is a private institution, where patients must pay for their treatment, according to their health insurance, which usually exclude nutritional products).
* Collaboration with data registry (nutritional assessment, adherence to the supplements, postoperative complications, etc.) due to the incorporation of one of their professionals (nutritionist) to the study.

Clinical Benefits of Preoperative Nutrition Support With Enteral Immune-enhancing Formulas in Surgical Oncology

Preoperative Nutrition Support in Major Oncologic Surgery

Registration of all eventual surgical complication after oncologic surgery, both during hospital stay and after 30 days after hospital discharge

University of Chile

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Heart and Blood Diseases

Diabetes Mellitus

Depressive Disorder

Depressive Disorder, Major

Depression

Hypertension

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Psychotropic Drugs

Vasoconstrictor Agents

Desvenlafaxine Succinate

Norepinephrine

Serotonin

Serotonin and Noradrenaline Reuptake Inhibitors

Neurotransmitter Agents

Antidepressive Agents

Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Desvenlafaxine

Omega 3 Fatty acids

Placebo (for Omega 3 fatty acid supplement)

Jayesh Kamath, MD PhD

To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety symptoms in patients with select medical conditions (cancer, cardiovascular diseases and diabetes).

Omega 3 FA Supplements as Augmentation in the Treatment of Depression

A Randomized, Double-Blind Placebo-controlled Study Evaluating the Efficacy of Omega 3 Fatty Acid Augmentation of Desvenlafaxine for the Treatment of Major Depressive Disorder in Patients With Medical Illness.

Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.

UConn Health

Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Desvenlafaxine

Omega 3 Fatty acids

2 subjects were randomized to this group

Desvenlafaxine + Omega 3 FA Supplement

Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Desvenlafaxine

Placebo (for Omega 3 fatty acid supplement)

3 subjects were randomized to this group

Desvenlafaxine + Placebo (for Omega 3 FA Supplement)

Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Desvenlafaxine

Omega 3 Fatty acids

Age range: 53 to 66 years Gender: 1 male and 1 female

Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Desvenlafaxine

Placebo (for Omega 3 fatty acid supplement) Age range: 53 to 66 years \] Gender: 1 male and 2 females

Total

Age, Categorical

Sex: Female, Male

White Non-Hispanic/Latino

Race/Ethnicity, Customized

United States

Region of Enrollment

Due to very low enrollment in both arms, only descriptive analyses was completed for both arms

Jayesh Kamath MD PhD

Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Desvenlafaxine

Omega 3 Fatty acids

Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Desvenlafaxine

Placebo (for Omega 3 fatty acid supplement)

Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutrition for Colorectal Cancer Patients and Neutrophil Functions	NCT01831310	Malnutrition Colorectal Canc...	Standard (Kabiv... Standard-Glutam... Standard-Omega ... Standard-glutam...	50 Years - 70 Years	Kocaeli University
Clinical Benefits of Preoperative Nutrition Support With Enteral Immune-enhancing Formulas in Surgical Oncology	NCT01032512	CANCER	SUPPORTAN + GLU... NO PREOPERATIVE...	- 80 Years	University of Chile
Omega 3 FA Supplements as Augmentation in the Treatment of Depression	NCT01803711	Major Depressio... Cancer Diabetes Cardiovascular ...	Desvenlafaxine Omega 3 Fatty a... Placebo (for Om...	18 Years -	UConn Health

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