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Dietary Intervention Modifies Gut Microbiota in Type 2 Diabetes.

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ClinicalTrials.gov Identifier: NCT03421301
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
University of Connecticut
Information provided by (Responsible Party):
Nimbe Torres y Torres, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: dietary portfolio Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
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)
Masking Description:

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.

Primary Purpose: Treatment
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.
Actual Study Start Date : August 7, 2014
Actual Primary Completion Date : September 28, 2016
Actual Study Completion Date : December 28, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1. Dietary portfolio (DP)
the dietary portfolio 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.

Placebo Comparator: 2. placebo (P)
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.




Primary Outcome Measures :
  1. intestinal microbiota [ Time Frame: Change from baseline gut microbiota at three months after the dietary intervention ]
    Measurement of intestinal microbiota by sequencing using the Illumina platform


Secondary Outcome Measures :
  1. Glucose metabolism profile [ Time Frame: Change from baseline serum glucose at three months after dietary intervention ]
    serum glucose (mg/dl)

  2. Glucose metabolism profile [ Time Frame: Change from baseline serum insulin at three months after dietary intervention ]
    serum insulin (µUI/ml)

  3. Glucose metabolism profile [ Time Frame: Change from baseline plasma HbA1c at three months after dietary intervention ]
    plasma glycated hemoglobin (HbA1c) (%)

  4. Lipid metabolism profile [ Time Frame: Change from baseline serum triglycerides at three months after dietary intervention ]
    serum triglycerides (mg/dl)

  5. Lipid metabolism profile [ Time Frame: Change from baseline serum total cholesterol at three months after dietary intervention ]
    serum total cholesterol (mg/dl)

  6. Lipid metabolism profile [ Time Frame: Change from baseline serum LDL cholesterol at three months after dietary intervention ]
    serum LDL cholesterol (mg/dl)

  7. Lipid metabolism profile [ Time Frame: Change from baseline serum HDL cholesterol at three months after dietary intervention ]
    serum HDL cholesterol (mg/dl)

  8. Lipid metabolism profile [ Time Frame: Change from baseline plasma free fatty acids at three months after dietary intervention ]
    plasma free fatty acids (FFA) (mmol/L)

  9. metabolomic profile [ Time Frame: Change from baseline plasma betaine at three months after dietary intervention ]
    plasma betaine (µmol/L)

  10. metabolomic profile [ Time Frame: Change from baseline plasma choline at three months after dietary intervention ]
    plasma choline (µmol/L)

  11. metabolomic profile [ Time Frame: Change from baseline plasma TMAO at three months after dietary intervention ]
    plasma trimethylamine oxide (TMAO) (µmol/L)

  12. metabolomic profile [ Time Frame: Change from baseline plasma BCAA at three months after dietary intervention ]
    plasma branched chain amino acids (BCAA) (µmol/L)

  13. inflammatory profile [ Time Frame: Change from baseline plasma LPS at three months after dietary intervention ]
    plasma lipopolysaccharide (LPS) (ng/ml)

  14. inflammatory profile [ Time Frame: Change from baseline serum CRP at three months after dietary intervention ]
    serum C reactive protein (CRP) (mg/dl)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421301


Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
University of Connecticut
Investigators
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Principal Investigator: Nimbe Torres, PhD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Publications of Results:

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Responsible Party: Nimbe Torres y Torres, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03421301    
Other Study ID Numbers: 1165
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nimbe Torres y Torres, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
gut microbiota
functional foods
branched chain amino acids
TMAO
type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases