An interventional study of Nutrawell Powder and Diet Only in Cancer of Pancreas, sponsored by Jonsson Comprehensive Cancer Center. Terminated at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by Jonsson Comprehensive Cancer Center · Not applicable, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 2 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
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Exclusion Criteria:
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.
Dietary Supplement: Nutrawell Powder · Dietary Supplement: OmegaRich fish oil supplement
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.
Other: Diet Only
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.
Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein)
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.
Anthropometric measurement: Weight
Weight in Kilograms
Time frame: At each visit outlined for 3 months
Anthropometric measurement: Body Composition
Body Composition: kilogram weight of lean body mass
Time frame: At each visit outlined for 3 months
Blood biochemistry
complete blood count
Time frame: At each visit outlined for 3 months
Blood biochemistry
Blood electrolytes
Time frame: At each visit outlined for 3 months
Blood biochemistry
Liver function test
Time frame: At each visit outlined for 3 months
Blood biochemistry
Lipid panel
Time frame: At each visit outlined for 3 months
Blood biochemistry
Pancreatic tumor markers
Time frame: At each visit outlined for 3 months
Blood biochemistry
Inflammatory markers
Time frame: At each visit outlined for 3 months
Physical activity
All subjects will be provided a pedometer to record daily steps.
Time frame: At each visit outlined for 3 months
Physical activity
A 6 minute walk will be done at each visit.
Time frame: At each visit outlined for 3 months
Physical activity
Karnofsky performance score
Time frame: At each visit outlined for 3 months
Quality of life: General
Measured with short form health survey (SF36)
Time frame: At each visit outlined for 3 months
Quality of life: Appetite
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)
Time frame: At each visit outlined for 3 months
Plan to share: No
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Jonsson Comprehensive Cancer Center