Effect of Functional Foods on Gut Microbiota in Metabolic Syndrome (MetS)

July 31, 2018 updated by: Nimbe Torres y Torres, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Please Select An Option Below
      • Mexico City, Please Select An Option Below, Mexico, 14080
        • Nimbe Torres y Torres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary portfolio (DP)
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
a package containing a mix of functional foods
Placebo Comparator: placebo (P)
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
a package containing maltodextrins and caseinate calcium to mimic the DP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change after 2.5 months of dietary intervention with respect to baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Nimbe y Torres, PhD, Instituto Nacional de Ciencias Médicas y Nutrición

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2014

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

July 15, 2018

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 793

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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