An interventional study of dietary portfolio in Type 2 Diabetes Mellitus, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Completed. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Not applicable, Interventional, and Treatment
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).
Exclusion Criteria:
the dietary portfolio was given daily in the breakfast and dinner for 2.5 months
Dietary Supplement: dietary portfolio
the placebo (P) was based was given daily in the breakfast and dinner for 2.5 months
Dietary Supplement: dietary portfolio
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.
intestinal microbiota
Measurement of intestinal microbiota by sequencing using the Illumina platform
Time frame: Change from baseline gut microbiota at three months after the dietary intervention
Glucose metabolism profile
serum glucose (mg/dl)
Time frame: Change from baseline serum glucose at three months after dietary intervention
Glucose metabolism profile
serum insulin (µUI/ml)
Time frame: Change from baseline serum insulin at three months after dietary intervention
Glucose metabolism profile
plasma glycated hemoglobin (HbA1c) (%)
Time frame: Change from baseline plasma HbA1c at three months after dietary intervention
Lipid metabolism profile
serum triglycerides (mg/dl)
Time frame: Change from baseline serum triglycerides at three months after dietary intervention
Lipid metabolism profile
serum total cholesterol (mg/dl)
Time frame: Change from baseline serum total cholesterol at three months after dietary intervention
Lipid metabolism profile
serum LDL cholesterol (mg/dl)
Time frame: Change from baseline serum LDL cholesterol at three months after dietary intervention
Lipid metabolism profile
serum HDL cholesterol (mg/dl)
Time frame: Change from baseline serum HDL cholesterol at three months after dietary intervention
Lipid metabolism profile
plasma free fatty acids (FFA) (mmol/L)
Time frame: Change from baseline plasma free fatty acids at three months after dietary intervention
metabolomic profile
plasma betaine (µmol/L)
Time frame: Change from baseline plasma betaine at three months after dietary intervention
metabolomic profile
plasma choline (µmol/L)
Time frame: Change from baseline plasma choline at three months after dietary intervention
metabolomic profile
plasma trimethylamine oxide (TMAO) (µmol/L)
Time frame: Change from baseline plasma TMAO at three months after dietary intervention
metabolomic profile
plasma branched chain amino acids (BCAA) (µmol/L)
Time frame: Change from baseline plasma BCAA at three months after dietary intervention
inflammatory profile
plasma lipopolysaccharide (LPS) (ng/ml)
Time frame: Change from baseline plasma LPS at three months after dietary intervention
inflammatory profile
serum C reactive protein (CRP) (mg/dl)
Time frame: Change from baseline serum CRP at three months after dietary intervention
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Plan to share: No
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran