Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Dietary Intervention With Functional Foods Reduce Metabolic Endotoxemia and Attenuates Biochemical Abnormalities in Subjects With Type 2 Diabetes by Modifying the Gut Microbiota.
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
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).
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