Effect of Functional Foods on Gut Microbiota in Metabolic Syndrome

NCT03611140 | Completed DMC

• 1 other identifier: 793
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; gut microbiota; metabolic endotoxemia; functional foods

Outcome Measures

Primary Outcomes (1)

• Intestinal microbiota

  Fecal samples were collected to isolate DNA and sequenced using the Illumina platform

  change after 2.5 months of dietary intervention with respect to baseline

Secondary Outcomes (9)

• glucose

  change after 2.5 months of dietary intervention with respect to baseline

• insulin

  change after 2.5 months of dietary intervention with respect to baseline

• glycated hemoglobin

  change after 2.5 months of dietary intervention with respect to baseline

• triglycerides

  change after 2.5 months of dietary intervention with respect to baseline

• cholesterol

  change after 2.5 months of dietary intervention with respect to baseline

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

DP DIETARY_SUPPLEMENT

a package containing a mix of functional foods

Dietary portfolio (DP)

Placebo DIETARY_SUPPLEMENT

a package containing maltodextrins and caseinate calcium to mimic the DP

placebo (P)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• \- 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
• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Nimbe Torres y Torres

Mexico City, Please Select An Option Below, 14080, Mexico

Location

Related Publications (12)

• 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.

  PMID: 15831718 BACKGROUND

• Ando 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.

  PMID: 19409982 RESULT

• Hansel 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.

  PMID: 17045077 RESULT

• Guevara-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.

  PMID: 22090467 RESULT

• Lopez-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.

  PMID: 25132122 RESULT

• Torres 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.

  PMID: 19917453 RESULT

• Jenkins 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.

  PMID: 18377791 RESULT

• Ascencio 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.

  PMID: 14988441 RESULT

• Sanchez-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.

  PMID: 28680065 RESULT

• Roberfroid 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.

  PMID: 10837317 RESULT

• Turnbaugh 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.

  PMID: 20368178 RESULT

• Guevara-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.

  PMID: 31451009 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nimbe y Torres, PhD

  Instituto Nacional de Ciencias Médicas y Nutrición

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: PD and placebo interventions were packaged identically in appearance, both the researcher and the participant did not know what type of maneuver was assigned. The packages were distributed by a person outside the study who was the same person who performed the randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 2, 2018
• Study Start: January 10, 2014
• Primary Completion: June 15, 2018
• Study Completion: July 15, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

ME (1)