Metabolic SyndromeMetSNCT03611140
Effect of Functional Foods on Gut Microbiota in Metabolic Syndrome
A study testing DP in people with Metabolic Syndrome, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Aim: To study the effect of a combination of functional foods on gut microbiota in subjects with metabolic syndrome. Subjects that met the metabolic syndrome criteria were enrolled in a double-blind, parallel-arm, placebo-control study. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- DP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jan 2014to 15 Jul 2018
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Adults between 20 and 60 years old
- BMI ≥ 20 to ≤ 25 kg/m2
- Patients with no criteria positive metabolic syndrome
- Patients who knew how to read and write
- Signature of informed consent
Show all 17Show fewer
- Male or female
- Adults between 20 and 60 years old
- BMI ≥ 25to ≤ 50 kg/m2
- Patients with 3 positive criteria of the metabolic syndrome
- Glucose > 100 to < 126 mg / dl
- Triglycerides > 150 mg / dl
- HDL-cholesterol: men < 40mg / dl and women <50 mg / dl
- Waist circumference > 80cm in women and> 90 cm in men
- Blood pressure ≥ 130/85 mmHg (in two different days)
- Patients who knew how to read and write
- Signature of informed consent
Who cannot join
- - Patients with any type of diabetes.
- Diseases that produce secondary obesity or diabetes
- Cardiovascular event
- Weight loss > 3 kgs in the last 3 months after the evaluation of the criteria
- Catabolic diseases such as cancer and acquired immunodeficiency syndrome
- Gravity status
Show all 22Show fewer
- Positive smoking
- Treatment with medications
- Treatment with antihypertensive drugs
- Treatment with hypoglycemic agents or insulin and antidiabetics.
- Treatment with statins, fibrates or other drugs to control the dyslipidemia.
- Use of steroid medications, chemotherapy, immunosuppressants or radiotherapy.
- Anorexigens or accelerate weight loss.
- Any drug or medication that activates intestinal motility
- Laxatives or antispasmodics 4 weeks before the study
- Treatment with antibiotics 2 months before the study
- Patients with a digestive functional disorder (constipation, diarrhea, dyspepsia, functional abdominal distension) (determined by questionnaire based on the classification of Rome II).
- Inflammatory bowel disease
- Irritable bowel syndrome or other chronic gastrointestinal diseases
- Major surgery
- Treatment with pro / pre / symbiotic
- High fiber foods consumption (more than 15 grams of fiber)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Nimbe Torres y Torres
Mexico City, Please Select An Option Below, 14080
About this study
Official title: Effect of a Dietary Portfolio (PD) (Nopal, Chia, Soy, Oat and Inulin) and Physical Activity on Gut Microbiota in Patients With Metabolic Syndrome
Aim: To study the effect of a combination of functional foods on gut microbiota in subjects with metabolic syndrome. Subjects that met the metabolic syndrome criteria were enrolled in a double-blind, parallel-arm, placebo-control study. The subjects were randomized to receive a dietary portfolio (DP) or placebo (P) treatment for 2 mo. The primary endpoint was to study the effect of a DP on gut microbiota. Secondary endpoints were biochemical and anthropometric parameters, LPS, insulin, leptin, area under the curve for glucose and insulin.
Read the detailed description
This study was a single-center, randomized, controlled, double-blind, parallel versus placebo that consisted of five visits. The first visit was a screening evaluation to determine whether subjects met the inclusion criteria. The selected subjects were invited to a second visit that consisted of a medical history, 2-h oral glucose tolerance test (OGTT), the collection of stool samples for DNA isolation and collection of 5 ml blood sample. The participants received during the first stage, a low saturated fat diet (LSFD) for 15 days. In the third visit and second stage of dietary treatment, subjects were randomized to receive the dietary portfolio (DP) or placebo (P) treatment + an LSFD accompanied of a reduced energy diet for 1 mo. In the fourth visit, with a 1 mo interval, dietary assessment and compliance to the DP or P were evaluated. During each follow-up visit, a 24-h dietary recall was collected, a physical activity questionnaire was filled out and anthropometric and clinical parameters were assessed. In the fifth visit, a 2 -h oral glucose tolerance test (OGTT) was performed, and a stool sample for DNA isolation and 5 ml blood were collected.
Dietary intervention in the first stage, the participants consumed a reduced-energy diet tailored to provide a 500-kcal/d deficit as recommended by NIH with respect to their habitual diet for 15 days. The diet plan consisted in 50-60% carbohydrates, 15% protein, 25-35% fat, <7% saturated fat, ≤ 200 mg, 20-35 g fiber, 2000 mg/d sodium based on total energy. In the second stage, the participants continued to consume the reduced energy diet with the addition of a combination of functional foods (DP). The DP provided 200 kcal that were subtracted from the diet. The DP consisted of a mixture of 14 g de dehydrated nopal, 4 g of chia, 25 g of soy protein, 14 g of oat, 4 g of inulin, 0.15 of flavoring. The placebo (P) consisted of 30 g of calcium caseinate, 30 g of maltodextrin and 0.2 g of flavoring. The kcal, appearance, and flavor were similar in DP and P. The DP and P were given in a package in the dehydrated form ready to be dissolved in water. The DP was divided into two packages, the first package contained 17.3 g of DP or P given in the breakfast and dissolved in 250 ml and the second package was given at the dinner time, and contained 34.7 g of P and DP dissolved in 300 ml of water.
Dietary compliance. Dietary compliance was assessed with a 24-h dietary recall and 3-d food record (food lo), during each visit that was analyzed by food processor nutrition analysis software. The compliance of the consumption of the DP or P was evaluated with the number of empty packages returned at the following visit. Physical activity was assessed using the International physical activity questionnaire (IPAQ)
- Conditions
- Metabolic Syndrome
- Being tested
- DP, Placebo
- Keywords
- metabolic syndrome, gut microbiota, metabolic endotoxemia, functional foods
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPDietary supplement
a package containing a mix of functional foods
PlaceboDietary supplement
a package containing maltodextrins and caseinate calcium to mimic the DP
| Study group | Role | What they receive |
|---|---|---|
| Dietary portfolio (DP) | Experimental | The dietary portfolio was given daily at the breakfast and dinner for 2 months. The dietary intervention was a combination of functional foods (dehydrated nopal, chia seed, soy protein, oat, and inulin) that was provided in a dehydrated form in packages of 30 g dissolved in 250 ml water for breakfast and 30 g in 250ml water for dinner. Receives: Dietary Supplement: DP |
| placebo (P) | Placebo comparator | The placebo (P) was given daily at the breakfast and dinner for 2 months. The placebo intervention consisted of a mixture of calcium caseinate, maltodextrins, sweetener and of artificial flavoring that was provided in a dehydrated form in packages of 30 g dissolved in 250 ml water for breakfast and 30 g in 250ml water for dinner. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiota
Fecal samples were collected to isolate DNA and sequenced using the Illumina platform
Measured: change after 2.5 months of dietary intervention with respect to baseline
Secondary outcomes (9)
glucose
serum glucose (mg/dl)
Measured: change after 2.5 months of dietary intervention with respect to baseline
insulin
serum insulin (µU/ml)
Measured: change after 2.5 months of dietary intervention with respect to baseline
glycated hemoglobin
plasma glycated hemoglobin (HbA1c) (%)
Measured: change after 2.5 months of dietary intervention with respect to baseline
triglycerides
serum triglycerides (mg/dl)
Measured: change after 2.5 months of dietary intervention with respect to baseline
cholesterol
serum total cholesterol (mg/dl)
Measured: change after 2.5 months of dietary intervention with respect to baseline
LDL cholesterol
serum LDL- cholesterol (mg/dl)
Measured: change after 2.5 months of dietary intervention with respect to baseline
HDL cholesterol
serum HDL- cholesterol (mg/dl)
Measured: change after 2.5 months of dietary intervention with respect to baseline
LPS
lipopolysaccharide (LPS) (ng/ml)
Measured: change after 2.5 months of dietary intervention with respect to baseline
CRP
serum C reactive protein (CRP) (mg/dl)
Measured: change after 2.5 months of dietary intervention with respect to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start10 Jan 2014
- Primary completion15 Jun 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Model description
- In the first stage, the participants with metabolic syndrome consumed a reduced-energy diet tailored to provide a 500 kcal/d deficit as recommended by NIH with respect to their habitual diet for 15 days. In the second stage, the participants continued to consume the reduced energy diet with the addition of a combination of functional foods (dietary portfolio; DP). The DP provided 200 kcal that were subtracted from the diet. The kcal, appearance, and flavor were similar in DP and P. The DP and P were given in a package in a dehydrated form ready to be dissolved in water. The DP was divided into two packages, the first package contained 30 g of DP o P given in the breakfast and dissolved in 250ml and the second package was given at the dinner time and contained 30 g of P and DP dissolved in 250 mL of water.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimbe Torres y Torres, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Nimbe y Torres, PhD, Principal investigator, Instituto Nacional de Ciencias Médicas y Nutrición
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611140
- Sponsor's protocol ID
- 793
- Acronym
- MetS
- Status last verified
- Jul 2018
- First submitted
- 25 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.
PubMed 15831718Ando K, Fujita T. Metabolic syndrome and oxidative stress. Free Radic Biol Med. 2009 Aug 1;47(3):213-8. doi: 10.1016/j.freeradbiomed.2009.04.030. Epub 2009 May 3.
PubMed 19409982Hansel B, Kontush A, Bonnefont-Rousselot D, Bruckert E, Chapman MJ. Alterations in lipoprotein defense against oxidative stress in metabolic syndrome. Curr Atheroscler Rep. 2006 Nov;8(6):501-9. doi: 10.1007/s11883-006-0026-8.
PubMed 17045077Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernandez-Viveros I, Lopez-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 Jan;142(1):64-9. doi: 10.3945/jn.111.147447. Epub 2011 Nov 16.
PubMed 22090467Lopez-Romero P, Pichardo-Ontiveros E, Avila-Nava A, Vazquez-Manjarrez N, Tovar AR, Pedraza-Chaverri J, Torres N. The effect of nopal (Opuntia ficus indica) on postprandial blood glucose, incretins, and antioxidant activity in Mexican patients with type 2 diabetes after consumption of two different composition breakfasts. J Acad Nutr Diet. 2014 Nov;114(11):1811-8. doi: 10.1016/j.jand.2014.06.352. Epub 2014 Aug 12.
PubMed 25132122Torres N, Guevara-Cruz M, Granados J, Vargas-Alarcon G, Gonzalez-Palacios B, Ramos-Barragan VE, Quiroz-Olguin G, Flores-Islas IM, Tovar AR. Reduction of serum lipids by soy protein and soluble fiber is not associated with the ABCG5/G8, apolipoprotein E, and apolipoprotein A1 polymorphisms in a group of hyperlipidemic Mexican subjects. Nutr Res. 2009 Oct;29(10):728-35. doi: 10.1016/j.nutres.2009.09.013.
PubMed 19917453Jenkins DJ, Josse AR, Wong JM, Nguyen TH, Kendall CW. The portfolio diet for cardiovascular risk reduction. Curr Atheroscler Rep. 2007 Dec;9(6):501-7. doi: 10.1007/s11883-007-0067-7.
PubMed 18377791Ascencio C, Torres N, Isoard-Acosta F, Gomez-Perez FJ, Hernandez-Pando R, Tovar AR. Soy protein affects serum insulin and hepatic SREBP-1 mRNA and reduces fatty liver in rats. J Nutr. 2004 Mar;134(3):522-9. doi: 10.1093/jn/134.3.522.
PubMed 14988441Sanchez-Tapia M, Aguilar-Lopez M, Perez-Cruz C, Pichardo-Ontiveros E, Wang M, Donovan SM, Tovar AR, Torres N. Nopal (Opuntia ficus indica) protects from metabolic endotoxemia by modifying gut microbiota in obese rats fed high fat/sucrose diet. Sci Rep. 2017 Jul 5;7(1):4716. doi: 10.1038/s41598-017-05096-4.
PubMed 28680065Roberfroid MB. Prebiotics and probiotics: are they functional foods? Am J Clin Nutr. 2000 Jun;71(6 Suppl):1682S-7S; discussion 1688S-90S. doi: 10.1093/ajcn/71.6.1682S.
PubMed 10837317Turnbaugh PJ, Ridaura VK, Faith JJ, Rey FE, Knight R, Gordon JI. The effect of diet on the human gut microbiome: a metagenomic analysis in humanized gnotobiotic mice. Sci Transl Med. 2009 Nov 11;1(6):6ra14. doi: 10.1126/scitranslmed.3000322.
PubMed 20368178Gonzalez-Salazar LE, Guizar-Heredia R, Flores-Lopez A, Aguilar-Lopez M, Medina-Vera I, Erazo-Tapia E, Pichardo-Ontiveros E, Orozco-Ruiz X, Vazquez-Manjarrez N, Serralde-Zuniga AE, Avila-Nava A, Gonzalez-Garay A, Hernandez-Gomez KG, Velazquez-Villegas LA, Noriega LG, Torres N, Tovar AR, Guevara-Cruz M. Dietary intervention modifies low-density lipoproteins particle size according to genetic variability: a clinical study. Clin Nutr ESPEN. 2026 Jun;73:103270. doi: 10.1016/j.clnesp.2026.103270. Epub 2026 Apr 1.
PubMed 41932609Guevara-Cruz M, Flores-Lopez AG, Aguilar-Lopez M, Sanchez-Tapia M, Medina-Vera I, Diaz D, Tovar AR, Torres N. Improvement of Lipoprotein Profile and Metabolic Endotoxemia by a Lifestyle Intervention That Modifies the Gut Microbiota in Subjects With Metabolic Syndrome. J Am Heart Assoc. 2019 Sep 3;8(17):e012401. doi: 10.1161/JAHA.119.012401. Epub 2019 Aug 27.
PubMed 31451009
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Dietary Portfolio (PD) (Nopal, Chia, Soy, Oat and Inulin) and Physical Activity on Gut Microbiota in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03611140
- Acronym / sponsor ID
- MetS / 793
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, gut microbiota, metabolic endotoxemia, functional foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- 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.
Aim: To study the effect of a combination of functional foods on gut microbiota in subjects with metabolic syndrome. Subjects that met the metabolic syndrome criteria were enrolled in a double-blind, parallel-arm, placebo-control study. The subjects were randomized to receive a dietary portfolio (DP) or placebo (P) treatment for 2 mo. The primary endpoint was to study the effect of a DP on gut microbiota. Secondary endpoints were biochemical and anthropometric parameters, LPS, insulin, leptin, area under the curve for glucose and insulin.
Detailed description
This study was a single-center, randomized, controlled, double-blind, parallel versus placebo that consisted of five visits. The first visit was a screening evaluation to determine whether subjects met the inclusion criteria. The selected subjects were invited to a second visit that consisted of a medical history, 2-h oral glucose tolerance test (OGTT), the collection of stool samples for DNA isolation and collection of 5 ml blood sample. The participants received during the first stage, a low saturated fat diet (LSFD) for 15 days. In the third visit and second stage of dietary treatment, subjects were randomized to receive the dietary portfolio (DP) or placebo (P) treatment + an LSFD accompanied of a reduced energy diet for 1 mo. In the fourth visit, with a 1 mo interval, dietary assessment and compliance to the DP or P were evaluated. During each follow-up visit, a 24-h dietary recall was collected, a physical activity questionnaire was filled out and anthropometric and clinical parameters were assessed. In the fifth visit, a 2 -h oral glucose tolerance test (OGTT) was performed, and a stool sample for DNA isolation and 5 ml blood were collected.
Dietary intervention in the first stage, the participants consumed a reduced-energy diet tailored to provide a 500-kcal/d deficit as recommended by NIH with respect to their habitual diet for 15 days. The diet plan consisted in 50-60% carbohydrates, 15% protein, 25-35% fat, <7% saturated fat, ≤ 200 mg, 20-35 g fiber, 2000 mg/d sodium based on total energy. In the second stage, the participants continued to consume the reduced energy diet with the addition of a combination of functional foods (DP). The DP provided 200 kcal that were subtracted from the diet. The DP consisted of a mixture of 14 g de dehydrated nopal, 4 g of chia, 25 g of soy protein, 14 g of oat, 4 g of inulin, 0.15 of flavoring. The placebo (P) consisted of 30 g of calcium caseinate, 30 g of maltodextrin and 0.2 g of flavoring. The kcal, appearance, and flavor were similar in DP and P. The DP and P were given in a package in the dehydrated form ready to be dissolved in water. The DP was divided into two packages, the first package contained 17.3 g of DP or P given in the breakfast and dissolved in 250 ml and the second package was given at the dinner time, and contained 34.7 g of P and DP dissolved in 300 ml of water.
Dietary compliance. Dietary compliance was assessed with a 24-h dietary recall and 3-d food record (food lo), during each visit that was analyzed by food processor nutrition analysis software. The compliance of the consumption of the DP or P was evaluated with the number of empty packages returned at the following visit. Physical activity was assessed using the International physical activity questionnaire (IPAQ)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In the first stage, the participants with metabolic syndrome consumed a reduced-energy diet tailored to provide a 500 kcal/d deficit as recommended by NIH with respect to their habitual diet for 15 days. In the second stage, the participants continued to consume the reduced energy diet with the addition of a combination of functional foods (dietary portfolio; DP). The DP provided 200 kcal that were subtracted from the diet. The kcal, appearance, and flavor were similar in DP and P. The DP and P were given in a package in a dehydrated form ready to be dissolved in water. The DP was divided into two packages, the first package contained 30 g of DP o P given in the breakfast and dissolved in 250ml and the second package was given at the dinner time and contained 30 g of P and DP dissolved in 250 mL of water.
| Arm | Type | Receives |
|---|---|---|
| Dietary portfolio (DP) | Experimental | Dietary Supplement: DPThe dietary portfolio was given daily at the breakfast and dinner for 2 months. The dietary intervention was a combination of functional foods (dehydrated nopal, chia seed, soy protein, oat, and inulin) that was provided in a dehydrated form in packages of 30 g dissolved in 250 ml water for breakfast and 30 g in 250ml water for dinner. |
| placebo (P) | Placebo comparator | Dietary Supplement: PlaceboThe placebo (P) was given daily at the breakfast and dinner for 2 months. The placebo intervention consisted of a mixture of calcium caseinate, maltodextrins, sweetener and of artificial flavoring that was provided in a dehydrated form in packages of 30 g dissolved in 250 ml water for breakfast and 30 g in 250ml water for dinner. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Male or female
- Adults between 20 and 60 years old
- BMI ≥ 20 to ≤ 25 kg/m2
- Patients with no criteria positive metabolic syndrome
- Patients who knew how to read and write
Key exclusion criteria (22 listed)
- - Patients with any type of diabetes.
- Diseases that produce secondary obesity or diabetes
- Cardiovascular event
- Weight loss > 3 kgs in the last 3 months after the evaluation of the criteria
- Catabolic diseases such as cancer and acquired immunodeficiency syndrome
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 |
|---|---|---|
| DPa package containing a mix of functional foods | Dietary supplement | Dietary portfolio (DP) |
| Placeboa package containing maltodextrins and caseinate calcium to mimic the DP | Dietary supplement | placebo (P) |
Primary outcome
Intestinal microbiota
Time frame: change after 2.5 months of dietary intervention with respect to baseline
Fecal samples were collected to isolate DNA and sequenced using the Illumina platform
9 secondary outcomes
glucose
Time frame: change after 2.5 months of dietary intervention with respect to baseline
insulin
Time frame: change after 2.5 months of dietary intervention with respect to baseline
glycated hemoglobin
Time frame: change after 2.5 months of dietary intervention with respect to baseline
triglycerides
Time frame: change after 2.5 months of dietary intervention with respect to baseline
cholesterol
Time frame: change after 2.5 months of dietary intervention with respect to baseline
LDL cholesterol
Time frame: change after 2.5 months of dietary intervention with respect to baseline
HDL cholesterol
Time frame: change after 2.5 months of dietary intervention with respect to baseline
LPS
Time frame: change after 2.5 months of dietary intervention with respect to baseline
CRP
Time frame: change after 2.5 months of dietary intervention with respect to baseline
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 2 Aug 2018.
- Background: PubMed 15831718Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.
- Results publication: PubMed 19409982Ando K, Fujita T. Metabolic syndrome and oxidative stress. Free Radic Biol Med. 2009 Aug 1;47(3):213-8. doi: 10.1016/j.freeradbiomed.2009.04.030. Epub 2009 May 3.
- Results publication: PubMed 17045077Hansel B, Kontush A, Bonnefont-Rousselot D, Bruckert E, Chapman MJ. Alterations in lipoprotein defense against oxidative stress in metabolic syndrome. Curr Atheroscler Rep. 2006 Nov;8(6):501-9. doi: 10.1007/s11883-006-0026-8.
- Results publication: PubMed 22090467Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernandez-Viveros I, Lopez-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 Jan;142(1):64-9. doi: 10.3945/jn.111.147447. Epub 2011 Nov 16.
- Results publication: PubMed 25132122Lopez-Romero P, Pichardo-Ontiveros E, Avila-Nava A, Vazquez-Manjarrez N, Tovar AR, Pedraza-Chaverri J, Torres N. The effect of nopal (Opuntia ficus indica) on postprandial blood glucose, incretins, and antioxidant activity in Mexican patients with type 2 diabetes after consumption of two different composition breakfasts. J Acad Nutr Diet. 2014 Nov;114(11):1811-8. doi: 10.1016/j.jand.2014.06.352. Epub 2014 Aug 12.
- Results publication: PubMed 19917453Torres N, Guevara-Cruz M, Granados J, Vargas-Alarcon G, Gonzalez-Palacios B, Ramos-Barragan VE, Quiroz-Olguin G, Flores-Islas IM, Tovar AR. Reduction of serum lipids by soy protein and soluble fiber is not associated with the ABCG5/G8, apolipoprotein E, and apolipoprotein A1 polymorphisms in a group of hyperlipidemic Mexican subjects. Nutr Res. 2009 Oct;29(10):728-35. doi: 10.1016/j.nutres.2009.09.013.
- Results publication: PubMed 18377791Jenkins DJ, Josse AR, Wong JM, Nguyen TH, Kendall CW. The portfolio diet for cardiovascular risk reduction. Curr Atheroscler Rep. 2007 Dec;9(6):501-7. doi: 10.1007/s11883-007-0067-7.
- Results publication: PubMed 14988441Ascencio C, Torres N, Isoard-Acosta F, Gomez-Perez FJ, Hernandez-Pando R, Tovar AR. Soy protein affects serum insulin and hepatic SREBP-1 mRNA and reduces fatty liver in rats. J Nutr. 2004 Mar;134(3):522-9. doi: 10.1093/jn/134.3.522.
- Results publication: PubMed 28680065Sanchez-Tapia M, Aguilar-Lopez M, Perez-Cruz C, Pichardo-Ontiveros E, Wang M, Donovan SM, Tovar AR, Torres N. Nopal (Opuntia ficus indica) protects from metabolic endotoxemia by modifying gut microbiota in obese rats fed high fat/sucrose diet. Sci Rep. 2017 Jul 5;7(1):4716. doi: 10.1038/s41598-017-05096-4.
- Results publication: PubMed 10837317Roberfroid MB. Prebiotics and probiotics: are they functional foods? Am J Clin Nutr. 2000 Jun;71(6 Suppl):1682S-7S; discussion 1688S-90S. doi: 10.1093/ajcn/71.6.1682S.
- Results publication: PubMed 20368178Turnbaugh PJ, Ridaura VK, Faith JJ, Rey FE, Knight R, Gordon JI. The effect of diet on the human gut microbiome: a metagenomic analysis in humanized gnotobiotic mice. Sci Transl Med. 2009 Nov 11;1(6):6ra14. doi: 10.1126/scitranslmed.3000322.
- Derived from this study: PubMed 41932609Gonzalez-Salazar LE, Guizar-Heredia R, Flores-Lopez A, Aguilar-Lopez M, Medina-Vera I, Erazo-Tapia E, Pichardo-Ontiveros E, Orozco-Ruiz X, Vazquez-Manjarrez N, Serralde-Zuniga AE, Avila-Nava A, Gonzalez-Garay A, Hernandez-Gomez KG, Velazquez-Villegas LA, Noriega LG, Torres N, Tovar AR, Guevara-Cruz M. Dietary intervention modifies low-density lipoproteins particle size according to genetic variability: a clinical study. Clin Nutr ESPEN. 2026 Jun;73:103270. doi: 10.1016/j.clnesp.2026.103270. Epub 2026 Apr 1.
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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.
Nimbe y Torres, PhD principal investigator
Instituto Nacional de Ciencias Médicas y Nutrición
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DP in people with Metabolic Syndrome, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 17 inclusion and 22 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 2 Aug 2018. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
Intestinal microbiota (time frame: change after 2.5 months of dietary intervention with respect to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03611140, which also lists 13 linked publications.
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 2 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.