Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Micronutrients

All Drugs and Chemicals

Other Dietary Supplements

Vitamins

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Omega 3 Fatty Acid

Tocopherol

Tocotrienol

Subjects will be evaluated by a registered dietitian with a diet prescription (55% carbohydrate, 30% fat and 15% protein) including Nutrawell powder with fish oil.

Subjects will be evaluated by a registered dietitian with a diet prescription (55% carbohydrate, 30% fat and 15% protein) not including servings of Nutrawell powder with fish oil.

The NutraWell nutrition powder will be provided by and distributed from New Health Nutraceuticals (Irvine, California - USA). Nutrawell is manufactured New Health Enterprises, Inc. The supplement sample will be stored at room temperature in the UCLA Center for Human Nutrition research unit.

OmegaRich Contains high concentration and high purity of natural omega-3 polyunsaturated fatty acids: Eicosapenatenoic acid (EPA) and docosahexaenoic acid (DHA) from deep water fish.

Enriched with natural vitamin E: d- tocopherol Triglyceride form (TG-form) of the raw fish oil ingredients. Each fish oil capsule contains 55% EPA and DHA with 330 mg EPA and 220 mg DHA.

Nutrawell Powder

Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein)

Diet Only

OmegaRich is manufactured New Health Enterprises, Inc. The supplement sample will be stored at room temperature in the UCLA Center for Human Nutrition research unit.

OmegaRich Contains: high concentration and high purity of natural omega-3 polyunsaturated fatty acids: Eicosapenatenoic acid (EPA) and docosahexaenoic acid (DHA) from deep water fish.

Enriched with natural vitamin E: d- tocopherol Triglyceride form (TG-form) of the raw fish oil ingredients. Each fish oil capsule contains 55% EPA and DHA with 330 mg EPA and 220 mg DHA.

OmegaRich fish oil supplement

Zhaoping Li, MD, PhD

There are few well-designed studies evaluating the effect of nutrition support in patients with cancer cachexia. The aim of this study is to examine the effect of dietary prescription with and without nutrition supplementation in patients with unresectable pancreatic cancer on body weight, body composition, total calorie intake, quality of life and blood inflammatory markers.

A total of 60 subjects will be recruited from The University of California Los Angeles (UCLA) Hirshberg Pancreatic Cancer Center, print and/or radio advertisements, UCLA campus wide e-mail, and flyers posted on campus and in the community. Participants will be pre-screened over the telephone to determine eligibility. Eligible subjects will be asked to come to the Center for Human Nutrition for a Screening Visit.

At screening, informed consent and authorization will be reviewed and signed a medical history will be obtained. The subjects will be screened by medical history/physical exam, a fasting blood sample will be collected for a comprehensive metabolic panel, a complete blood count, chemistry and liver function tests.

Day 1 will be the first study day. Subjects will come to the UCLA Center for Human Nutrition in the fasting state and remain for approximately \~1 hour. The food intake record will be collected and entered into the Automated Self- Administered Food Recall (NIH ASA24). The vital signs, anthropometric assessments will be measured and quality of life questionnaire will be completed.

A fasting blood sample (20 ml) will be collected for metabolic panel and inflammatory markers. A 6-minute walk will be done at the research center.

Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein) vs. the same diet prescription including three servings of supplement powder and fish oil. The research dietitian will develop meal plans based on basal metabolic rate and physical activity. Subjects will be provided a pedometer to wear daily. Any subject in either group who develops symptoms of pancreatic insufficiency will be provided with pancreatic enzyme supplementation.

Day 28, 56, 84 and 112 will be follow-up visits. The same procedures will be performed as on day 1. Subjects will come to the UCLA Center for Human Nutrition in the fasting state and remain for approximately \~1 hour.

Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer

Body Composition: kilogram weight of lean body mass

All subjects will be provided a pedometer to record daily steps.

A 6 minute walk will be done at each visit.

Measured with short form health survey (SF36)

Appetite will be measured on a numerical rating scale between 0 and 10, where 0 indicated absolutely no appetite and 10 indicated an extremely good appetite (Simons et al, 1996)

Do Well Laboratories Inc.

Hirshberg Foundation for Pancreatic Cancer Research

Jonsson Comprehensive Cancer Center

Mathilde Touvier, Dr

Pilar Galan, Dr

Serge Hercberg, Pr

Emmanuelle Kesse-Guyot, Dr

Sandrine Péneau, Dr

Léopold Fezeu, Dr

Chantal Julia, Dr

Valentina Andreeva, Dr

Allès Benjamin, Dr

Baudry Julia, Dr

Deschasaux Mélanie, Dr

The NutriNet-Santé study was set up to investigate nutrition and health relationships. Specifically, it was the first web-based cohort worldwide on such a large scale (n=171 000 as of 2021) focused on the complex link between nutrition and health status. It is characterized by a very detailed assessment of nutritional exposure and dietary behavior.

https://etude-nutrinet-sante.fr/ https://info.etude-nutrinet-sante.fr/en

NutriNet-Santé is a large-scale (n=171,000) web-based cohort coordinated by EREN, launched in France in 2009 to investigate nutrition and health relationships. All required ethics authorisations have been obtained (listed here). NutriNet-Santé participants regularly fill questionnaires through a dedicated and secure website, providing extensive, high-quality nutritional and non-nutritional data, including repeated data on socio-demographics and lifestyle (yearly), anthropometrics (every 6 months), dietary intake (every 6 months), physical activity (IPAQ questionnaire, yearly)5 and health status (every 6 months). NutriNet-Santé is characterised by a very detailed and up-to-date assessment of nutritional exposure and dietary behaviours. Usual dietary intakes are assessed at baseline and every 6 months thereafter through a series of 3 non-consecutive randomly assigned 24h dietary records. Daily energy, alcohol, micro- and macronutrient intakes are calculated using the published NutriNet-Santé food composition database (\>3,500 generic items). All major health events (e.g., cancers, cardio- and cerebrovascular diseases) are reported by the participants and validated by an expert committee of physicians based on medical records, and/or retrieved from the French National Health Insurance medico-administrative databases to limit potential reporting bias. In turn, mortality data are obtained from the exhaustive French National Mortality Registry (CépiDC). The number of incident events already registered is as follows: 4,200 cancers and 1,240 deaths. A sub-sample of the cohort (n=20,000) provided blood and urine samples, currently stored at -80°C in EREN's biobank.

Samples of serum, plasma, and buffy-coats (for genetic analyses), as well as urine samples was set up for 19 600 subjects of the cohort.

The NutriNet-Santé Study

The NutriNet-Santé Study. A Web-based Prospective Cohort Study of the Relationship Between Nutrition and Health and of Dietary Patterns and Nutritional Status Predictors

self reported though validated scales and/or questionnaires

combination of previsously listed mental and physical health outcomes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer	NCT02681601	Cancer of Pancr...	Nutrawell Powde... Diet Only OmegaRich fish ...	18 Years - 75 Years	Jonsson Comprehensive Cancer Center
Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer	NCT02681601	Cancer of Pancr...	Nutrawell Powde... Diet Only OmegaRich fish ...	18 Years - 75 Years	Jonsson Comprehensive Cancer Center
The NutriNet-Santé Study	NCT03335644	Diet, Food, and... Exercise Diseases Catego... Cohort Studies Adult Anthropometry Humans Internet Surveys and Que... Mortality		15 Years -	University of Paris 13
The NutriNet-Santé Study	NCT03335644	Diet, Food, and... Exercise Diseases Catego... Cohort Studies Adult Anthropometry Humans Internet Surveys and Que... Mortality		15 Years -	University of Paris 13

Spots Global Cancer Trial Database for diet, food, and nutrition