Effect of a dietary portfolio on metabolic syndrome
| ISRCTN | ISRCTN96579359 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96579359 |
| Secondary identifying numbers | PICDS08-6 |
- Submission date
- 08/12/2010
- Registration date
- 17/02/2011
- Last edited
- 14/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nimbe Torres
Scientific
Scientific
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Dept. Fisiologia de la Nutricion
Vasco de Quiroga No. 15
Col. Seccion XVI
Mexico
14000
Mexico
Study information
| Study design | Single centre randomised placebo-controlled double-blind parallel-arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patients information sheet |
| 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 |
| Study acronym | SNAC-MS |
| Study objectives | 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(s) | Ethics Committees of the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran approved on the 19th March 2009 (ref: 1966) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nopal, chia seed, soy protein, oatmeal |
| Primary outcome measure | 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 study start date | 01/08/2009 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 97 participants |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico
14000
Mexico
14000
Mexico
Sponsor information
Institution of Science and Technology of Mexico City (Instituto de Ciencia y Tecnología del Distrito Federal) (Mexico)
Government
Government
Republica de Chile No 6
Col.Centro
Deleg Cuauhtemoc
Mexico
06010
Mexico
| Website | https://www.icyt.df.gob.mx |
|---|---|
"ROR" |
https://ror.org/01fncf688 |
Funders
Funder type
Government
Institution of Science and Technology of Mexico City (Instituto de Ciencia y Tecnología del Distrito Federal) (Mexico)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |
