Modulation of Secondary Bile Acids Through the Intestinal Microbiota After Consumption of a High-protein Diet.

March 4, 2024 updated by: Armando Tovar, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
This study will investigate whether changes in the gut microbiota generated after the consumption of a high protein diet in healthy subjects, modify the production of secondary bile acids. In addition, it will be seen whether a high protein intake modifies postprandial glucose response and its relationship with gut microbiota composition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The gut microbiota is a set of microorganisms that inhabit the human digestive tract and are fundamental for the health of the host. Among the functions of the gut microbiota is the production of metabolites, such as the production of secondary bile acids from primary bile acids. On the other hand, evidence has shown that the amount of protein intake can modify the composition of the gut microbiota and in turn it increase the concentration of secondary biles acids in animal models. In addition, the consumption of a high-protein diet has been related to a decrease in postprandial glucose concentrations. Therefore, the aim of this study is to evaluate changes in secondary bile acids concentration derived from gut microbiota after the consumption of a high-protein diet in healthy subjects. Subjects with a BMI between 18.5 and 24.9 kg/m2 will be selected and will be continuously monitored with a continuous glucose monitor through 15 days. During the first 7 days participants will follow an isocaloric diet (50% carbohydrates, 30% fat and 20% protein), while during the last 7 days participants will receive an intervention with a supplement of protein (calcium caseinate) which will increase their protein intake to 30% of the total energy requirement. At the initial and final visit, blood samples will be taken for determination of biochemical parameters, amino acids and primary bile acids and a stool sample will be requested for sequencing gut microbiota and determined secondary bile acids.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male and female.
  • Between 18 and older
  • BMI ≥ 18.5 and ≤ 24.9 kg/m2.
  • Healthy
  • Willing and able to sign written informed consent prior to trial entry

Exclusion Criteria:

  • Have previously diagnosed with any chronic disease
  • Patients with high blood pressure.
  • Patients who have suffered a cardiovascular event.
  • Patients with gastrointestinal diseases.
  • Weight loss > 3 kg in the last 3 months.
  • Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
  • Pregnancy status.
  • Antibiotic consumption 3 months prior to the study.
  • Be an undergraduate or graduate student within the Institute.
  • Subjects with creatinine > 1.3 mg/dL for men and >1 mg/dL for women and ureic nitrogen > 20 mg/dL.
  • Positive smoking.

  • Drug treatment:

    1. Antihypertensive drugs or treatment
    2. Treatment with hypoglycemic agents or insulin and antidiabetic drugs.
    3. Treatment with statins, fibrates or other drugs to control dyslipidemia.
    4. Use of antibiotics in the three months prior to the study.
    5. Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy.
    6. Anorexigenic or that accelerate weight loss such as sibutramine or orlistat.
    7. Probiotic, prebiotic or symbiotic supplements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-protein diet
Participants will receive an isocaloric diet with a distribution of 50% carbohydrates, 30% fat and 20% protein for the two-week intervention. Additionally, they will receive a dietary supplement for the second week that will contribute another 10% of protein, obtaining 30% of protein consumption in the second week.
Dietary supplement: High-protein diet
Protein intake will be increased to be 30% calories from protein with calcium caseinate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in faecal microbiota composition in response to high-protein diet
Time Frame: baseline, 7 days and 14 days
Changes to the faecal microbiota will be assessed on a high-protein diet compared to an isocaloric diet in a short period of time. Bacterial composition was measured by 16 ribosomal sequencing at baseline at day 7 and at the end of the second week. The relative change of each bacterial taxon was calculated based on the abundance of the given bacteria at baseline, at 7 days and after 14 days
baseline, 7 days and 14 days
Increase of secondary bile acids production
Time Frame: baseline, 7 days and 14 days
Increase in the concentrations of lithocholic acid and deoxycholic acid in feces (mg/g of feces) measured by the method gas chromatography represented with the units micromol.
baseline, 7 days and 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regulation of postprandial glucose response
Time Frame: 14 days
Change in interstitial glucose determined by a continuous glucose monitor (mg/dL) within two weeks.
14 days
Increase in serum glucagon concentration
Time Frame: Baseline, 7 days and 14 days
Change in serum glucagon concentration determined by ELISA (pg/mL)
Baseline, 7 days and 14 days
Decrease in serum insulin concentration
Time Frame: Baseline, 7 days and 14 days
Change in serum insulin concentration determined by ELISA (pg/mL)
Baseline, 7 days and 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Armando R Tovar, Doctor, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Study Chair: Maria del Rocio Guizar-Heredia, Master, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Study Director: Martha Guevara-Cruz, Doctor, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 4532

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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