Study to Evaluate the Effect of a Vegetal Oil on Cognitive Impairment

June 1, 2016 updated by: Team Foods Colombia S.A.

Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of a Vegetal Oil in the Disease's Natural Evolution in Patients Diagnosed With Cognitive Impairment or Mild to Moderate Alzheimer Disease.

The aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with a composition related to short, medium and long unsaturated chain fatty acids on patients with a diagnose of cognitive impairment or mild to moderate Alzheimer disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The cognitive impairment syndrome is defined as a decrease of the intellectual performance with respect to a previous step in time. The Cognitive impairment has to be considered as a functional alteration with a continuous and physiological evolution in which happen a set of different circumstances:

  • A increasing and normal reduction, that appears after the age of sixty, also known as Age-associated memory impairment (AAMI)
  • A mild cognitive impairment (MCI), with a recent and mild loss of memory, but higher to that expected because of patient's age and educational level.
  • A severe pathological decrease of the mental abilities, also known as, depending on its characteristics: Severe cognitive impairment (SCI), senile dementia and Alzheimer's disease (1).

In the next years it is expected that this disease will become one of the main health and aged-related problem in aged people.(2) Nowadays, there are 35,6 million people with any kind of dementia, and it is estimated that every year, 7,7 million of new patients are diagnosed. (3) The amount of people affected will probably duplicate every 20 years, if effective treatments to stop its evolution are not developed. The forecast estimate up to 81,1 million of patients in 2040, which make this disease in a XXI century real epidemic.(4)

Before reaching the level of dementia, SCI or Alzheimer's disease, the patient will suffer a progressive mild cognitive impairment. In this level, the disease can be early diagnosed and it would be worth to act on it.

Evidences of the Polyunsaturated oils use on the prevention and/or treatment of cognitive impairment.

Polyunsaturated fatty acids (PUFA) can help to improve the cognitive functions. Neuronal tissues, as the brain, retina and the neurone-covering membranes (myelin) include high levels of PUFA. (5) PUFA's act on the order transmission in the Nervous System. Population studies reported the beneficial effect of fish oil, with a high PUFA concentration, on the memory of patients suffering a mild cognitive impairment. (6) It can be also beneficial for Alzheimer's patients, as they are deficient in PUFA's. A diet rich in PUFA'S can improve the cognitive function on patients con cognitive impairment and Alzheimer's disease. (6-8) Epidemiological studies suggest that oils rich in short chain PUFA, should play a beneficial role stopping the initial progression of Alzheimer's disease.

The previous data confirm the possibility of a beneficial effect of the product to study (a mixture of vegetable oils, rich in triglyceride and lecithins) due to the common characteristic of the product with those PUFA's already marketed.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • informed consents signed by patients and/or caretaker
  • The patient has to fulfil dementia clinical criteria.
  • Age between 55 and 85 years old.
  • MMSE score between 18 and 26.
  • The patient can fulfil all neuropsychologic test, according to investigator.
  • The patient has to be always with his/her caretaker during monitorization visits
  • The caretaker has to be in regular contact with the patient, knowing his/her situation and participation in the study.
  • The caretaker has to check four times per week, at least, the product intake, as well as the routine medication and his/her dietetic habits.
  • Both caretaker and patient have to be able to complete the product intake during all the length of the study, according to the main investigator.

Exclusion Criteria:

  • Patient and/or caretaker not being able to understand and agree in writing their participation in the study.
  • Patient disability to oral intake of products.
  • Known allergy to any of the product components (active and placebo)
  • Evidence of suffering other neuropsychiatric disturbances apart of dementia as: Parkinson disease, psychotic disturbance, bipolar depression.
  • regular intake of alcohol higher than 45 g ethanol/day, during the year before study inclusion.
  • Any known concurrent malignant pathology in the moment of study inclusion, or severe metabolic, cardiovascular, renal, hepatic, or gastrointestinal disease that cannot allow the ending of the study according the investigator.
  • Any analytical abnormality during the screening, apart from: Creatinine no less than 1.7 mg/dL; low levels of Vitamin B12, and TSH abnormal values.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lipidic Blend 1
Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day
Dietary supplement: Lipidic Blend 1
daily intake of the content of one 45 mL bottle containing the product
Active Comparator: Lipidic Blend 2
Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day
Dietary supplement: Lipidic Blend 2
daily intake of the content of one 45 mL bottle containing the product
Placebo Comparator: Placebo
Glass bottle with 45 ml of Olive oil. 1 bottle per day
Dietary supplement: Placebo
daily intake of the content of one 45 mL bottle containing olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Mini-Mental State Examination (MMSE) score
Time Frame: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
Changes in Global Clinical Dementia Rating (CDR) score
Time Frame: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in systemic oxidative parameters in periferic blood samples (Nitric Oxyde)
Time Frame: baseline, 12 month
baseline, 12 month
Changes in systemic oxidative parameters in periferic blood samples (Malondialdehyde (MDA))
Time Frame: baseline, 12 month
baseline, 12 month
Changes in beta-amyloid protein concentration
Time Frame: baseline, 12 month
Changes in mean values on high sensitivity beta-amyloid 1-40 and 1-42 protein and TAU-protein in cerebrospinal fluid on those patients with a new diagnose of mild to moderate cognitive impairment, that require an initial lumbar puncture and a new lumbar puncture to control evolution at the end of teh study.
baseline, 12 month
Changes in TAU-Protein concentration
Time Frame: baseline, 12 month
Changes in mean values on high sensitivity beta-amyloid 1-40 and 1-42 protein and TAU-protein in cerebrospinal fluid on those patients with a new diagnose of mild to moderate cognitive impairment, that require an initial lumbar puncture and a new lumbar puncture to control evolution at the end of teh study.
baseline, 12 month
Changes in regular treatment for the cognitive impairment
Time Frame: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
Changes in dietetic habits
Time Frame: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
Changes in Barthel score
Time Frame: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
Changes in Morisky-Green score
Time Frame: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
changes in weight
Time Frame: baseline, 3 month, 6 month, 9 month, 12 month
baseline, 3 month, 6 month, 9 month, 12 month
Number of adverse events
Time Frame: baseline, 3 month, 6 month, 9 month, 12 month
Number of adverse events related or nonrelated to the study or placebo products.
baseline, 3 month, 6 month, 9 month, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Team Foods Colombia S.A.

Collaborators

Biopolis S.L.

Investigators

  • Study Director: Vicente Navarro-López, MD, Universidad Católica San Antonio de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

May 8, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALZ-OIL.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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