Mild Cognitive ImpairmentNCT01286389
Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
A study testing medical care and caloric restriction in people with Mild Cognitive Impairment and Obesity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Obesity has been associated with cognitive impairments, lower blood flow, metabolic activity and brain volume. Obesity in adulthood is a risk factor for Alzheimer's disease in the elderly. The mild cognitive impairment (MCI) is a condition that may precede dementia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Obesity
- What is being tested?
- medical care and caloric restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index (BMI) ≥ 30 kg/m2
- independent for most of the instrumental activities of daily life;
- literate;
- able to walk,
- diagnosis of mild cognitive impairment
Who cannot join
- weight loss greater than 3 kg over the past two months,
- presence of uncontrolled disease that potentially interfere with metabolism and weight gain or whose treatment would influence the cognitive performance, such as major depression, bulimia, hypothyroidism, Cushing's disease, heart failure, neoplasia in the last 3 years, alcoholism, infectious diseases and auto-immune activity;
- use of anti-obesity drugs, benzodiazepines, neuroleptics or estrogen replacement therapy in the past 2 months;
- previous bariatric surgery,
- severe sensory deficit
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas - Faculdade de Medicina da USP
São Paulo, São Paulo, 05403010
About this study
Obesity has been associated with cognitive impairments, lower blood flow, metabolic activity and brain volume. Obesity in adulthood is a risk factor for Alzheimer's disease in the elderly. The mild cognitive impairment (MCI) is a condition that may precede dementia. We hypothesized that promotion of weight loss in obese people with MCI, through caloric restriction could lead to improvement in cognitive performance or reduction in the rate of decline and decreased risk of dementia. A sample of 80 patients aged ≥ 60 years, obese, with MCI, will be randomized to two groups that will be followed for 12 months. The control group will receive conventional medical care. The intervention group will receive nutritional counseling individually and in groups, aiming to promote weight loss through caloric restriction, and medical monitoring. Before and after intervention patients will be evaluated for anthropometry, body composition, physical performance, control of comorbidities, laboratory tests (glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP), Genotyping apolipoprotein E, neuropsychological battery, questionnaires about activities of daily living, physical activity and diet.
Read the detailed description
Objectives: To evaluate the cognitive performance of obese patients with MCI and the effect of weight loss induced by caloric restriction on cognition, conversion to dementia, to assess weight loss, changes in inflammatory and metabolic parameters, change in physical capacity, performance in neuropsychological tests and correlate with effects of the intervention. Methods: The patients will be randomized to two groups that will be followed for 12 months. The control group will receive conventional medical care. The intervention group will receive nutritional counseling individually and in groups, aiming to promote weight loss (10% of body weight) through caloric restriction, and medical monitoring. Everyone will be advised to physical activity. Before and after 12 months patients will be evaluated for anthropometry, body composition, physical performance, control of comorbidities, laboratory tests (glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP), Genotyping apolipoprotein E, neuropsychological battery, questionnaires about activities of daily living, physical activity and diet.
- Conditions
- Mild Cognitive Impairment, Obesity
- Being tested
- medical care, caloric restriction
- Keywords
- Mild cognitive impairment, Dementia, Obesity, Overweight, diet, caloric restriction, body composition, weight loss
- Medical subject headings
- Cognitive Dysfunction, Obesity, Dementia, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical careOther
Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
caloric restrictionBehavioural
Also called diet
Nutritional guidance: through at least 2 individual assistance and group sessions, lasting 1 hour, weekly for 4 months, and biweekly for 2 months and monthly thereafter (26-28 meetings/1year).The diet plan will recommend a deficit from 500 to 750 kcal/day in order to promote loss of about 0.5kg/week, containing 1g/kg of protein per day (minimum 1200kcal/day), high in fiber, vegetables and whole foods. The goal of weight loss will be 10% of initial weight. Group activities consist of lectures on nutrition education, food composition and its importance to health, food preparation techniques, self-monitoring weight, eating behavior and count calories.
| Study group | Role | What they receive |
|---|---|---|
| Conventional medical care | Active comparator | Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet) Receives: Other: medical care |
| caloric restriction +medical care | Experimental | Nutritional counseling individually and in groups, aiming to promote weight loss (10% of body weight) through caloric restriction, +Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise) Receives: Other: medical care; Behavioral: caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological test performance
Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Subjective Memory Complaints scale and CAMcog from CAMDEX (The Cambridge Examination for Mental Disorders of the Elderly, The Rivermead Behavioural Memory, The Wisconsin Card Sorting Task, trail making test part A and B, The Rey auditory-verbal learning test, semantic and phonologic verbal fluency test, digits (WAIS-III), vocabulary (WAIS - III), matrix (WAIS - III)
Measured: baseline and 12 months
Diagnosis of dementia
The diagnosis of dementia will be given from the DSM IV TR: The diagnosis of Alzheimer's disease will be defined according to DSM IV.
Measured: 12 months
Weight loss
anthropometry (weight, height, BMI, waist circumference, hip circumference), body composition by bioimpedance
Measured: 12 months
Secondary outcomes (7)
plasma biomarkers
glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP
Measured: 0 and 12 months
Genotyping apolipoprotein E
The genotype is a covariate to assess response to treatment
Measured: baseline
Charlson comorbidity index
Measured: 0 and 12 moths
International physical activity questionnaire- short version (IPAQ)
Measured: 0 and 12 moths
Evaluation of Food Consumption
Measured: 0 and 12 moths
SPPB- Short physical performance battery
Measured: 0 and 12 moths
Blood pressure
Measured: 0 and 12 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Nídia Celeste Horie, University of Sao Paulo General Hospital
- Investigators
- Alfredo Hapern, professor, Study director, Sao Paulo UniversityNídia Horie, Principal investigator, pos graduation student of Sao Paulo UniversityCintia Cercato, professor, Study chair, Sao Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286389
- Sponsor's protocol ID
- 0706/10 CAPPesq
- Status last verified
- Nov 2014
- First submitted
- 27 Jan 2011
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
- ClinicalTrials.gov ID
- NCT01286389
- Acronym / sponsor ID
- 0706/10 CAPPesq
- Conditions
- Mild Cognitive Impairment, Obesity
- Keywords
- Mild cognitive impairment, Dementia, Obesity, Overweight, diet, caloric restriction, body composition, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity has been associated with cognitive impairments, lower blood flow, metabolic activity and brain volume. Obesity in adulthood is a risk factor for Alzheimer's disease in the elderly. The mild cognitive impairment (MCI) is a condition that may precede dementia. We hypothesized that promotion of weight loss in obese people with MCI, through caloric restriction could lead to improvement in cognitive performance or reduction in the rate of decline and decreased risk of dementia. A sample of 80 patients aged ≥ 60 years, obese, with MCI, will be randomized to two groups that will be followed for 12 months. The control group will receive conventional medical care. The intervention group will receive nutritional counseling individually and in groups, aiming to promote weight loss through caloric restriction, and medical monitoring. Before and after intervention patients will be evaluated for anthropometry, body composition, physical performance, control of comorbidities, laboratory tests (glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP), Genotyping apolipoprotein E, neuropsychological battery, questionnaires about activities of daily living, physical activity and diet.
Detailed description
Objectives: To evaluate the cognitive performance of obese patients with MCI and the effect of weight loss induced by caloric restriction on cognition, conversion to dementia, to assess weight loss, changes in inflammatory and metabolic parameters, change in physical capacity, performance in neuropsychological tests and correlate with effects of the intervention. Methods: The patients will be randomized to two groups that will be followed for 12 months. The control group will receive conventional medical care. The intervention group will receive nutritional counseling individually and in groups, aiming to promote weight loss (10% of body weight) through caloric restriction, and medical monitoring. Everyone will be advised to physical activity. Before and after 12 months patients will be evaluated for anthropometry, body composition, physical performance, control of comorbidities, laboratory tests (glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP), Genotyping apolipoprotein E, neuropsychological battery, questionnaires about activities of daily living, physical activity and diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional medical care | Active comparator | Other: medical careConventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet) |
| caloric restriction +medical care | Experimental | Other: medical care, Behavioral: caloric restrictionNutritional counseling individually and in groups, aiming to promote weight loss (10% of body weight) through caloric restriction, +Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- body mass index (BMI) ≥ 30 kg/m2
- independent for most of the instrumental activities of daily life;
- literate;
- able to walk,
- diagnosis of mild cognitive impairment
Key exclusion criteria (5 listed)
- weight loss greater than 3 kg over the past two months,
- presence of uncontrolled disease that potentially interfere with metabolism and weight gain or whose treatment would influence the cognitive performance, such as major depression, bulimia, hypothyroidism, Cushing's disease, heart failure, neoplasia in the last 3 years, alcoholism, infectious diseases and auto-immune activity;
- use of anti-obesity drugs, benzodiazepines, neuroleptics or estrogen replacement therapy in the past 2 months;
- previous bariatric surgery,
- severe sensory deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical careConventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet) | Other | Conventional medical care, caloric restriction +medical care |
| caloric restrictionAlso: dietNutritional guidance: through at least 2 individual assistance and group sessions, lasting 1 hour, weekly for 4 months, and biweekly for 2 months and monthly thereafter (26-28 meetings/1year).The diet plan will recommend a deficit from 500 to 750 kcal/day in order to promote loss of about 0.5kg/week, containing 1g/kg of protein per day (minimum 1200kcal/day), high in fiber, vegetables and whole foods. The goal of weight loss will be 10% of initial weight. Group activities consist of lectures on nutrition education, food composition and its importance to health, food preparation techniques, self-monitoring weight, eating behavior and count calories. | Behavioural | caloric restriction +medical care |
Primary outcome
Neuropsychological test performance
Time frame: baseline and 12 months
Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Subjective Memory Complaints scale and CAMcog from CAMDEX (The Cambridge Examination for Mental Disorders of the Elderly, The Rivermead Behavioural Memory, The Wisconsin Card Sorting Task, trail making test part A and B, The Rey auditory-verbal learning test, semantic and phonologic verbal fluency test, digits (WAIS-III), vocabulary (WAIS - III), matrix (WAIS - III)
Diagnosis of dementia
Time frame: 12 months
The diagnosis of dementia will be given from the DSM IV TR: The diagnosis of Alzheimer's disease will be defined according to DSM IV.
Weight loss
Time frame: 12 months
anthropometry (weight, height, BMI, waist circumference, hip circumference), body composition by bioimpedance
7 secondary outcomes
plasma biomarkers
Time frame: 0 and 12 months
Genotyping apolipoprotein E
Time frame: baseline
Charlson comorbidity index
Time frame: 0 and 12 moths
International physical activity questionnaire- short version (IPAQ)
Time frame: 0 and 12 moths
Evaluation of Food Consumption
Time frame: 0 and 12 moths
SPPB- Short physical performance battery
Time frame: 0 and 12 moths
Blood pressure
Time frame: 0 and 12 moths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Hapern, professor study director
Sao Paulo University
Nídia Horie principal investigator
pos graduation student of Sao Paulo University
Cintia Cercato, professor study chair
Sao Paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical care and caloric restriction in people with Mild Cognitive Impairment and Obesity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological test performance (time frame: baseline and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.