Dietary Intervention Modifies Gut Microbiota in Type 2 Diabetes.

NCT03421301 | Completed DMC

• 1 other identifier: 1165
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Type 2 Diabetes Mellitus

Keywords

gut microbiota; functional foods; branched chain amino acids; TMAO; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Glucose metabolism profile

  Change from baseline serum glucose at three months after dietary intervention

• Glucose metabolism profile

  Change from baseline serum insulin at three months after dietary intervention

• Glucose metabolism profile

  Change from baseline plasma HbA1c at three months after dietary intervention

• Lipid metabolism profile

  Change from baseline serum triglycerides at three months after dietary intervention

• Lipid metabolism profile

  Change from baseline serum total cholesterol at three months after dietary intervention

Study Arms (2)

1. Dietary portfolio (DP)

EXPERIMENTAL

the dietary portfolio was given daily in the breakfast and dinner for 2.5 months

Dietary Supplement: dietary portfolio

2. placebo (P)

PLACEBO COMPARATOR

the placebo (P) was based was given daily in the breakfast and dinner for 2.5 months

Dietary Supplement: dietary portfolio

Interventions

dietary portfolio DIETARY_SUPPLEMENT

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.

1. Dietary portfolio (DP); 2. placebo (P)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• University of Connecticut: collaborator

Related Publications (25)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nimbe Torres, PhD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: PD and placebo interventions were packaged identically in appearance, both the researcher and the participant did not know what type of maneuver was assigned. The envelopes were distributed by a person outside the study who was the same who performed the randomization. Study staff and participants were blinded during the assignment and execution of interventions in the study. The packages given to the participants were 2 per day, the placebo packages were matched in grams, calories, color, appearance, flavor to the PD.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 5, 2018
• Study Start: August 7, 2014
• Primary Completion: September 28, 2016
• Study Completion: December 28, 2016
• Last Updated: February 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share