Effect of Functional Foods on Gut Microbiota in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— MetS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611140
• Other study ID #: 793
• Status: Completed
• Phase: N/A
• Start date: January 10, 2014
• Est. completion date: July 15, 2018

Study information

• Verified date: July 2018
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Inclusion Criteria for controls (healthy)

• 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

Inclusion Criteria of cases

• 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

Exclusion Criteria:

• - 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

• 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)

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• DP
a package containing a mix of functional foods
• Placebo
a package containing maltodextrins and caseinate calcium to mimic the DP

Locations

Country	Name	City	State
Mexico	Nimbe Torres y Torres	Mexico City	Please Select An Option Below

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

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. Review. — View Citation

Ascencio C, Torres N, Isoard-Acosta F, Gómez-Pérez FJ, Hernández-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. — View Citation

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. Epub 2005 Apr 14. — View Citation

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 s — View Citation

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. Review. — View Citation

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. Review. — View Citation

López-Romero P, Pichardo-Ontiveros E, Avila-Nava A, Vázquez-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 — View Citation

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. Review. — View Citation

Sánchez-Tapia M, Aguilar-López M, Pérez-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. 20 — View Citation

Torres N, Guevara-Cruz M, Granados J, Vargas-Alarcón G, González-Palacios B, Ramos-Barragan VE, Quiroz-Olguín 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, a — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	glucose	serum glucose (mg/dl)	change after 2.5 months of dietary intervention with respect to baseline
Secondary	insulin	serum insulin (µU/ml)	change after 2.5 months of dietary intervention with respect to baseline
Secondary	glycated hemoglobin	plasma glycated hemoglobin (HbA1c) (%)	change after 2.5 months of dietary intervention with respect to baseline
Secondary	triglycerides	serum triglycerides (mg/dl)	change after 2.5 months of dietary intervention with respect to baseline
Secondary	cholesterol	serum total cholesterol (mg/dl)	change after 2.5 months of dietary intervention with respect to baseline
Secondary	LDL cholesterol	serum LDL- cholesterol (mg/dl)	change after 2.5 months of dietary intervention with respect to baseline
Secondary	HDL cholesterol	serum HDL- cholesterol (mg/dl)	change after 2.5 months of dietary intervention with respect to baseline
Secondary	LPS	lipopolysaccharide (LPS) (ng/ml)	change after 2.5 months of dietary intervention with respect to baseline
Secondary	CRP	serum C reactive protein (CRP) (mg/dl)	change after 2.5 months of dietary intervention with respect to baseline