Dietary Intervention Modifies Gut Microbiota in Type 2 Diabetes.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Aim: To study the effect of a dietary intervention with functional foods on gut microbiota in
      subjects with type 2 diabetes Materials and methods: Patients with type 2 diabetes were
      enrolled in a double-blind, parallel-arm, placebo-control study were randomized to receive a
      dietary portfolio (DP) or placebo (P) treatment for 3 mo. The primary endpoint was the effect
      of a dietary portfolio based on functional foods on gut microbiota. Secondary endpoints were
      biochemical parameters, branched chain amino acids, TMAO
    

Detailed description: 
      This study was a single-center, randomized, controlled, double-blind, parallel versus placebo
      that consisted of six visits. The first visit was a screening evaluation to determine whether
      subjects meet 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), collection of
      stool samples for DNA isolation and collection of 5 ml blood sample. The participants
      received the first stage dietary strategy for 15 days. In the third visit and second stage of
      dietary treatment, subjects were randomized to received the dietary portfolio (DP) or placebo
      (P) treatment accompanied of the reduced energy diet for 1 mo. In the fourth and fifth
      visits, with a 1 mo interval, dietary assessment and compliance to the DP or P was 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
      sixth 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 (8) the with respect to their
      habitual diet for 15 days. The diet plan consisted in 45-55% carbohydrates, 15-20% protein,
      25-35% fat, <7% saturated fat, 200 mg/d cholesterol, 20-35g fiber, 2000-3000 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 (dietary portfolio; DP).
      The DP provided 200 kcal that were subtracted from the diet. The DP consisted of a mixture of
      14g of dehydrated nopal, 4g of chia seed, 30g of soy protein, 4g of inulin,) and 1g of
      flavoring. The placebo (P) consisted of 28 g of calcium caseinate, 15g of maltodextrin and 1g
      of flavoring. The kcal, appearance and flavor were similar in DP and P. The DP and P was
      given in a package in 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 (15:00-16:00 h) and
      contained 34.7g 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 log), during each visit that were 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): dietary portfolio
Intervention type(s): Dietary Supplement
Intervention description(s): The dietary intervention was a combination of functional foods (dehydrated nopal, chia seed, soy protein and inulin) that was provided in dehydrated form in packages of 17.3 g dissolved in 250 ml water for breakfast and 34.7 g in 300 ml water for dinner.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the first stage, the participants with type 2 diabetes consumed a reduced-energy diet tailored to provide a 500-kcal/d deficit as recommended by NIH (8) the 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 DP consisted of a mi The kcal, appearance and flavor were similar in DP and P. The DP and P was given in a package in 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 (15:00-16:00 h) and contained 34.7g of P and DP dissolved in 300 mL of water.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gut microbiota; functional foods; branched chain amino acids; TMAO; type 2 diabetes