Digestive System Diseases

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Symptoms and General Pathology

Neoplasms

Gastrointestinal Diseases

Postoperative Complications

Gastrointestinal Neoplasms

Digestive System Neoplasms

low calorie, low nitrogen parenteral nutrition for patient with NRS score 3

Wen-hua Zhan, MD,FACS

Zhu-Ming Jiang, MD, FACS

The study is designed to investigate the influence of parenteral nutrition (PN) with low nitrogen and calorie supply on the clinical outcome of patients after an operation compared to that of traditional PNs.

Wretlind from Sweden invented fat emulsion as early as 1961, which has been applied to parenteral nutrition. Dudrick and Wilmore from America introduced intravenous nutrition containing carbohydrates and amino acids, which was termed as high intravenous nutrition in 1967. Afterwards, it was proven that this treatment cannot improve clinical outcome but increases complications, such as infection, etc. Because of the action of catecholamine and corticosteroids under stress after an operation, insulin resistance becomes a main indicator of endocrine problems for patients. Under such circumstances, even intake of glucose at physiological doses can result in hyperglycosemia and increase the incidence of complications of infection and metabolism. Overseas and domestic scholars studied parenteral nutrition (PN) with low nitrogen and calorie supply long ago, and the results revealed that PN with low nitrogen and calorie supply can significantly decrease oxygen consumption of patients under stress of an operation, alleviate the inflammation response, reduce the rate of cholestasis and cut the treatment cost during hospitalization. On the other hand, catabolism of protein significantly increases after operation and trauma, but it cannot be simply corrected by high dose amino acid intake. Contrarily, improperly increasing of the intake of amino acids aggravates metabolism further. A domestic study on PN with a low calorie supply has revealed benefits on the clinical outcome of patients after an operation, such as a domestic randomised controlled study that has proven that intravenous nutrition with a low nitrogen and calorie supply significantly lowered the level of blood glucose, cut nutrition related medicine costs, shortened the length of hospital stay and reduced the incidence of phlebitis after operation, and also has the tendency to reduce the incidence of complications after an operation. Meta analysis has revealed that PN with a low nitrogen and calorie supply can control blood glucose better and may reduce the incidence of infection related complications, and has the tendency of shortening the length of hospital stay.

The development of all-in-one PN has experienced the process of sequential single bottle infusion, poly-bottle serial infusion, hospital prepared all-in-one solution and industrialized three compartment bags, and currently, the utilization of industrialized three compartment bags has been the dominant tendency of clinical parenteral nutrition among countries in Europe and Asia. Domestically Kabiven peripheral (FK, Germany, 1440 ml H20040008, 1920 ml H20040019) are the first three compartment bags, which is a pre-filling standard all-in-one nutrition solution. The two specifications (1440 ml,1920 ml) first launched to the market already satisfy most demands of PN support for patients, and provide PN with a low nitrogen and calorie supplying administration platform for patients after operation, spare time for the preparation of all-in-one nutrition solution, and avoid preparing such solutions under the common clean condition in hospitals.

Up to now, there is no report of a randomized controlled study about the utilization of three compartment bags domestically.

The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients

Comparing With Traditional Nitrogen Calorie Parenteral Nutrition Support, the Impact of Low Calorie and Low Nitrogen Intake on the Clinical Outcome of Gastrointestinal Postoperative Patients, Multicentre Post-Marketing Clinical Study

Guangzhou S Y S Medical School hospital

Wuhan TongJi Hospital

Beijing 301 hospital

Jie-Ping Wu Medical Foundation

Sino-Swed Pharmaceutical Corporation

ZM Jiang

Nutritional and Metabolic Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Overweight

Syndrome

Obesity

Infertility

Polycystic Ovary Syndrome

Overnutrition

Nutrition Disorders

Body Weight

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. We will also ask participants to keep foods low in fat and low in glycemic index.

A low-calorie diet contains all food groups. However, participants will be provided with a calorie goal which should promote weight loss.

Diet

Brie Turner-McGrievy, PhD, MS, RD

This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly by measuring changes in weight. Participants will be randomly assigned to following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means you will be asked to favor foods that don't cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will receive counseling and supporting materials on the dietary approach you are assigned to follow. Both diets are safe and have shown to be effective ways to assist with achieving a healthy weight. The investigators hypothesize that both groups will see improvements in weight and fertility with possible greater improvements seen among participants in the vegan group.

This study involves two groups. You will be randomly assigned to one of these groups (i.e. you do not have a choice for group assignment) which means your group will be assigned to you by chance, like flipping a coin. Both groups will be assigned to receive information on a dietary approach to lose weight. One group will receive instruction on a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day). The other group will be instructed on how to follow a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means you will be asked to favor foods that don't cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Below are the steps in the study:

* If you are accepted into the study, you will come to the study site (USC School of Public Health) to learn more about the study and complete your consent form. If you live outside the Columbia, SC area (more than a 6o mile drive), then you may complete orientation to the study over the phone and Web. You will then be mailed a consent form which we will discuss over the phone. You can then sign the consent form (keeping one copy for yourself and having a witness sign it as well) and mail it back. Once that is received by study personnel, a copy with a research personnel's signature will be mailed back to you. You may then begin the study.
* This study will involve 3-4 in-person visits to the School of Public Health at USC's Columbia campus, each lasting less than 2 hours each.
* You will then complete some questionnaires that will measure your diet and physical activity levels at home from a computer.
* You will come back for a meeting to have your weight, height, waist, and hip circumference measured. You will then be randomly assigned to one of the two groups: calorie controlled group or vegan diet group. You will receive a one-hour overview of the diet you have been assigned to and be provided with materials on this diet.
* During the study, we will ask you to complete a weekly questionnaire which will assess if you are following the diet, your weight, and ask for information on your menstrual cycle. This will take approximately 5 minutes to complete.
* You will then be provided individualized feedback each week via e-mail on your progress, along with a weekly lesson on the topic for the week.
* You will also have access to a group website (a private Facebook group) that will provide group support. Participation using this group is optional.
* You will be provided with test strips to monitor ovulation each month and pregnancy tests (1 per month) to monitor pregnancy status. You will report these results to us via online survey.
* Study personnel will host a weekly 30 minute webinar for your diet group online. This will take place after work time on a weekday. Make-up sessions by phone during the work day will be available.
* At 3 months, you will be asked to complete another set of questionnaires from home and return to our study site for your weight, waist, and hip circumference measurements. You will receive a $10 incentive for completing the 3-month assessment. You will also receive a $5 incentive each month that you provide your menstrual cycle data (using the test strips) and pregnancy tests results-which you will receive at the 3 month meeting (for a total of $25 possible at month 3).
* You will then continue the study for the next 3 months.
* At study completion (6 months), you will complete the last set of questionnaire (online from home). Also, you will come to a follow-up assessment to be weighed, have your waist and hip circumference measured, and to receive your incentive for participating ($10 +$5/month of each menstrual cycle data submitted for a total of $25 possible).
* If you become pregnant during the course of the study, you will be advised to consult your care provider. Because this is a weight loss study, we cannot allow continued participation but would like to record your weight measurement and other questionnaire data prior to study discontinuation. If you choose to continue to follow your assigned dietary approach, we can provide information on the diet to your physician, who can advise you on how to proceed.
* Participants in both groups will be asked to take a daily prenatal vitamin (or other reliable source of vitamin B-12) over the course of the study.
* During the study, we will ask you to keep your physical activity levels constant (keep your levels the same as what you were doing at study entry).

Healthy Eating for Reproductive Health (HERHealth)

body weight will be assessed at 0, 3, and 6 months

We will measure any occurrences of pregnancy over the course of the study

We will measure changes in the length of menstrual cycles over the course of the 6 month study

Academy of Nutrition and Dietetics

University of South Carolina

Associate Professor

Weight Loss

Participants in this arm will be instructed on how to reduce their caloric intake and follow a low calorie diet

Participants in this arm will follow a very low fat diet (\~10% kcals from fat) and also a diet that has a low glycemic index and is free of animal products (vegan)

Vegan diet

Low calorie diet

Brie Turner-McGrievy, PhD

This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly by measuring changes in weight. Participants will be randomly assigned to following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means the consumer will be asked to favor foods that don't cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will receive counseling and supporting materials on the dietary approach the participants are assigned to follow. Both diets are safe and have shown to be effective ways to assist with achieving a healthy weight. The investigators hypothesize that both groups will see improvements in weight and fertility with possible greater improvements seen among participants in the vegan group.

This study involves two groups. You will be randomly assigned to one of these groups (i.e. you do not have a choice for group assignment) which means your group will be assigned to you by chance. Both groups will receive information on a dietary approach aimed at losing weight.

One group will receive instruction on a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day). The other group will be instructed to follow a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this will be a low-glycemic index diet, which means you will be asked to favor foods that don't cause a quick rise in blood sugar (for example, choosing oatmeal over cornflakes for breakfast).

Below are the steps in the study:

If you are accepted into the study, you will come to the study site (Fertility Center of the Carolinas in Greenville) to learn more about the study and complete your consent form. If you live outside the Columbia, SC area (more than a 60 mile drive), you may complete the study orientation process over the phone and Web. You will be mailed a consent form to sign and return to the study coordinator. This study will involve 3-4 in-person visits to the Fertility Center of the Carolinas office, each lasting approximately 1.5 to 2 hours.

You will complete some questionnaires that measure your diet and physical activity levels on a computer at home or other location where you have computer/internet access.

You will come back for a meeting to have your weight measured. You will then be randomly assigned to one of the two groups: calorie controlled group or vegan diet group. You will receive a one-hour overview of the diet you have been assigned to and be provided with materials on this diet.

During the study, we will ask you to complete a weekly questionnaire which will assess if you are following the diet, your weight, and ask for information on your menstrual cycle. This will take approximately 5 minutes to complete.

You will be provided individualized feedback each week via e-mail on your progress, along with a weekly lesson on the topic for the week.

You will have access to a group website (a private Facebook group) that will provide group support. Participation using this group is optional.

You will be provided with test strips to monitor ovulation each month and pregnancy tests (1 per month) to monitor pregnancy status. You will report these results to us via online survey.

Study personnel will host a weekly 30 minute webinar for your diet group online. This will take place after work time on a weekday. Make-up sessions by phone during the work day will be available.

At 3 months, you will be asked to complete another set of questionnaires from home and return to our study site for your weight measurement.

You will continue the study for the next 3 months. At study completion (6 months), you will complete the last set of questionnaires (online). Also, you will come to a follow-up assessment to be weighed and to receive your incentive for participating ($10 +$5/month of each menstrual cycle data submitted for a total of $25 possible).

Participants in both groups will be asked to take a daily prenatal vitamin (or other reliable source of vitamin B-12) over the course of the study.

During the study, we will ask you to keep your physical activity levels constant (keep your levels the same as what you were doing at study entry).

Healthy Eating for Reproductive Health: Greenville

Prisma Health-Upstate

Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients	NCT00247338	Gastrointestina... Postoperative C...	low calorie, lo...	18 Years - 80 Years	Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Healthy Eating for Reproductive Health (HERHealth)	NCT01509066	Polycystic Ovar... Infertility Obesity Overweight	Diet	18 Years - 35 Years	University of South Carolina
The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients	NCT00247338	Gastrointestina... Postoperative C...	low calorie, lo...	18 Years - 80 Years	Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Healthy Eating for Reproductive Health: Greenville	NCT01716429	Polycystic Ovar... Infertility Obesity Overweight	Vegan diet Low calorie die...	18 Years - 35 Years	University of South Carolina
Healthy Eating for Reproductive Health: Greenville	NCT01716429	Polycystic Ovar... Infertility Obesity Overweight	Vegan diet Low calorie die...	18 Years - 35 Years	University of South Carolina
The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients	NCT00247338	Gastrointestina... Postoperative C...	low calorie, lo...	18 Years - 80 Years	Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd

Spots Global Cancer Trial Database for low calorie

Every month we try and update this database with for low calorie cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for low calorie

Every month we try and update this database with for low calorie cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for low calorie cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.