Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PICDS08-6
Study information
Scientific title
A clinical trial of the effect of a dietary portfolio (nopal, chia seed, soy protein and oatmeal) on parameters associated with metabolic syndrome
Acronym
SNAC-MS
Study hypothesis
Patients with metabolic syndrome (MS) who use a portfolio-based dietary nopal, chia seed, soy protein and oats have a better response on the biochemical parameters of the SM and the area under the glucose curve and insulin in the test of glucose tolerance, compared with patients who do not consume this portfolio over a period of two months.
Ethics approval
Ethics Committees of the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran approved on the 19th March 2009 (ref: 1966)
Study design
Single centre randomised placebo-controlled double-blind parallel-arm study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patients information sheet
Condition
Metabolic syndrome
Intervention
The patients with metabolic syndrome, once they have met with the selection criteria, will participate in two stages. The first one is to standardise the diet in all patients, so that the members are instructed to consume a diet low in saturated fat, according to ATPIII program and with a reduction in 500 calories to their usual diet for two weeks, the second stage consisted in the assignment treatment (placebo or dietary portfolio). By using a randomised by balanced block by an independent person to study, with duration of two months.
In this stage, the subjects consume the same diet that in the first stage less the calories contained in the dietary portfolio or placebo (250 calories). The subjects had a medical examination every month, and were also attended by the nutrition staff to evaluate the diet with a 24 hours-recall and every third days patients record the daily dietary intake.
The study consisted of four visits during the monitoring period. At the first visit take place a medical history, and glucose and insulin curve with 75g of glucose of 120 minutes. During each visiti 24 hour recall, application of questionnaire physical activity, anthropometry, serum parameters are measured.
Intervention type
Drug
Phase
Not Applicable
Drug names
Nopal, chia seed, soy protein, oatmeal
Primary outcome measures
1. Area under the curve (AUC) of the glucose, insulin and tryglicerides after of glucose tolerance test at baseline and at the end of the intervention
2. Serum leptin, adiponectin and C reactive protein at baseline and at the end of the intervention
Measures at baseline, two weeks, six weeks and ten weeks:
1. Anthropometric measurement
2. Physical activity
3. Resting blood pressure
4. Lipid profile: serum total cholesterol (TC), trygliceride (TG), HDL-cholesterol, LDL-cholesterol
5. Fasting serum glucose concentration
6. Fasting serum insulin concentration
7. Food intake
Secondary outcome measures
1. Polymorphism of ABCA1 R230C (rs9282541); Pro12Ala (rs1801282) and Gly972Arg (rs1801278) genes
2. G/I ratio, HOMA, QUICKI, Matsuda and Gutt indexes
Overall trial start date
01/08/2009
Overall trial end date
30/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Mexican mestizos
2. Men and women aged 20 - 60 years
3. Body mass index (BMI in kg/m^2) between 25 and 39.9
4. Recruited from the surrounding community of Mexico City
5. Present three or more signs of metabolic syndrome following:
5.1. Fasting plasma glucose between 100 mg/dl and 126 mg/dl
5.2. Triacylglycerol (TG) level greater than 150 mg/dl
5.3. Low high density lipoprotein (HDL) cholesterol (less than 40 mg/dl for men, less than 50 mg/dl for women)
5.4. Waist circumference greater than 102 cm for men, greater than 88 cm for women
5.5. Systolic blood pressure greater than 130 mmHg and greater than 85 mmHg diastolic
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
97 participants
Participant exclusion criteria
1. Patients with glucose greater than or equal to 126 mmHg or diagnosed by a doctor with any type of diabetes, diseases that occur secondarily acquired obesity and diabetes
2. History of cardiovascular event
3. Weight loss greater than 3 kg in the last three months
4. Catabolic disease as cancer and acquired immune deficiency virus (AIDS)
5. Pregnancy
6. Smoking history
7. History of substance abuse or alcoholism
8. No subject should have taken any lipid-lowering medication, antihypertensive, hypoglycaemic, steroids, chemotherapy, immunosuppressant, radiation, and anorectics six month prior to treatment
9. Taking regular nutritional supplements
10. Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg
Recruitment start date
01/08/2009
Recruitment end date
30/06/2010
Locations
Countries of recruitment
Mexico
Trial participating centre
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico
14000
Mexico
Sponsor information
Organisation
Institution of Science and Technology of Mexico City (Instituto de Ciencia y Tecnología del Distrito Federal) (Mexico)
Sponsor details
Republica de Chile No 6
Col.Centro
Deleg Cuauhtemoc
Mexico
06010
Mexico
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Institution of Science and Technology of Mexico City (Instituto de Ciencia y Tecnología del Distrito Federal) (Mexico)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22090467
Publication citations
-
Results
Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernández-Viveros I, López-Romero P, Ordaz-Nava G, Canizales-Quinteros S, Guillen Pineda LE, Torres N, A dietary pattern including nopal, chia seed, soy protein, and oat reduces serum triglycerides and glucose intolerance in patients with metabolic syndrome., J. Nutr., 2012, 142, 1, 64-69, doi: 10.3945/jn.111.147447.