Dietary Intervention Modifies Gut Microbiota in Type 2 Diabetes.

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421301
• Other study ID #: 1165
• Status: Completed
• Phase: N/A
• First received: January 17, 2018
• Last updated: January 29, 2018
• Start date: August 7, 2014
• Est. completion date: December 28, 2016

Study information

• Verified date: January 2018
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 28, 2016
• Est. primary completion date: September 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of type 2 diabetes

• Male or female.

• Adults between 30 and 60 years old.

• BMI of 25 to 39.9 kg / m².

• Pharmacological treatment with metformin, a combination of metformin and glibenclamide.

• Evolution of the type 2 diabetes of 4 ± 3 years.

• Patients who knew how to read and write.

• Signature of informed consent.

Exclusion Criteria:

• Diseases that produce secondary obesity.

• Cardiovascular event.

• Weight loss> 3 kg in the last 3 months after the evaluation of the criteria.

• Catabolic diseases such as cancer and acquired immunodeficiency syndrome.

• Gravidity status.

• Positive smoking.

• Treatment with antihypertensive drugs

• Treatment with other hypoglycemic agents that were not metformin

• Treatment with statins, fibrates or other drugs to control dyslipidemia, 6 months before the start of the protocol.

• Any drug or medication that activates intestinal motility

• Use of laxatives or antispasmodics 4 weeks before the study

• Treatment with antibiotics 6 months before the study

• Use of steroids, chemotherapy, immunosuppressant or radiotherapy.

• Uncontrolled type 2 diabetes, ( HbA1c concentration = 9.9%)

• Fasting glucose = 220 mg / dL

• Fasting cholesterol = 240 mg / dL

• Fasting triglycerides = 350 mg / dL

• Serum creatinine in women> 1.2 mg / dL in men> 1.3 mg / d

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	University of Connecticut

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intestinal microbiota	Measurement of intestinal microbiota by sequencing using the Illumina platform	Change from baseline gut microbiota at three months after the dietary intervention
Secondary	Glucose metabolism profile	serum glucose (mg/dl)	Change from baseline serum glucose at three months after dietary intervention
Secondary	Glucose metabolism profile	serum insulin (µUI/ml)	Change from baseline serum insulin at three months after dietary intervention
Secondary	Glucose metabolism profile	plasma glycated hemoglobin (HbA1c) (%)	Change from baseline plasma HbA1c at three months after dietary intervention
Secondary	Lipid metabolism profile	serum triglycerides (mg/dl)	Change from baseline serum triglycerides at three months after dietary intervention
Secondary	Lipid metabolism profile	serum total cholesterol (mg/dl)	Change from baseline serum total cholesterol at three months after dietary intervention
Secondary	Lipid metabolism profile	serum LDL cholesterol (mg/dl)	Change from baseline serum LDL cholesterol at three months after dietary intervention
Secondary	Lipid metabolism profile	serum HDL cholesterol (mg/dl)	Change from baseline serum HDL cholesterol at three months after dietary intervention
Secondary	Lipid metabolism profile	plasma free fatty acids (FFA) (mmol/L)	Change from baseline plasma free fatty acids at three months after dietary intervention
Secondary	metabolomic profile	plasma betaine (µmol/L)	Change from baseline plasma betaine at three months after dietary intervention
Secondary	metabolomic profile	plasma choline (µmol/L)	Change from baseline plasma choline at three months after dietary intervention
Secondary	metabolomic profile	plasma trimethylamine oxide (TMAO) (µmol/L)	Change from baseline plasma TMAO at three months after dietary intervention
Secondary	metabolomic profile	plasma branched chain amino acids (BCAA) (µmol/L)	Change from baseline plasma BCAA at three months after dietary intervention
Secondary	inflammatory profile	plasma lipopolysaccharide (LPS) (ng/ml)	Change from baseline plasma LPS at three months after dietary intervention
Secondary	inflammatory profile	serum C reactive protein (CRP) (mg/dl)	Change from baseline serum CRP at three months after dietary intervention