Evaluation of the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Cancer and Malnutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-08-01

Brief Summary

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Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition

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Detailed Description

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Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 8 weeks of duration and 2 study groups of treatment: Experimental group (experimental nutritional oral supplement); and Control group (control nutritional oral supplement) to evaluate the effect on the nutritional and functional status, the quality of life and body composition of patients with cancer and malnutrition undergoint specficic treatment (chemotherapy, radiotherapy, inmunotherapy).

Conditions

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Malnutrition Cancer Nutrition Related Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental Group

Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement

Group Type EXPERIMENTAL

Experimental Group

Intervention Type DIETARY_SUPPLEMENT

Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber and omega-3 enriched, with L-leucine, betaglucans and medium chain triglycerides) for 8 weeks.

Control group

Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type DIETARY_SUPPLEMENT

Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber) for 8 weeks.

Interventions

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Experimental Group

Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber and omega-3 enriched, with L-leucine, betaglucans and medium chain triglycerides) for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Control Group

Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber) for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Men and women over 18 with a cancer diagnosis (any type).
* Subjects who have initiated during the next mont a treatment with chemo and or radiotherapy with or without surgery.
* Having lost more than 5% of body weight in the last 6 months.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent.

Exclusion Criteria

* Subjects who are participating in other clinical trials.
* Subjects with morbid obesity.
* Subjects who will undergo surgery or who will undergo.
* Subjects with cachexia
* Subjects with infection of a cause other than of the tumor
* Subjects with an infectious process
* Subjects with Diabetes Mellitus treated with insulin and/or not controlled
* Subjects with kidney, heart, respiratory or liver disease.
* Subjects with autoimmune diseases.
* Subjects with mental illness or decrease function cognitive.
* Subjects who consume oral supplements or artificial nutrition and who cannot be withdran at least 1 week before startint the study.
* Patients who have consumed food supplements or fortified foods in omega 3 (arginine or nucleotides) during the previous month.
* Patients who reject oral supplements.
* Pregnant or breastfeeding women.
* Allergic to any component of the formula

Minimum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No