Effect of Functional Foods on Gut Microbiota in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

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.
    

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)
    

Intervention name(s): DP; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): a package containing a mix of functional foods; a package containing maltodextrins and caseinate calcium to mimic the DP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Primary purpose: Treatment
Keywords: metabolic syndrome; gut microbiota; metabolic endotoxemia; functional foods