NCT05906641

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

June 7, 2023

Last Update Submit

March 4, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Changes in faecal microbiota composition in response to high-protein diet

    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

    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 Outcomes (3)

  • Regulation of postprandial glucose response

    14 days

  • Increase in serum glucagon concentration

    Baseline, 7 days and 14 days

  • Decrease in serum insulin concentration

    Baseline, 7 days and 14 days

Study Arms (1)

High-protein diet

EXPERIMENTAL

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

Interventions

High-protein dietDIETARY_SUPPLEMENT

Protein intake will be increased to be 30% calories from protein with calcium caseinate.

High-protein diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • Antihypertensive drugs or treatment
  • Treatment with hypoglycemic agents or insulin and antidiabetic drugs.
  • Treatment with statins, fibrates or other drugs to control dyslipidemia.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

Mexico City, Mexico

Location

Related Publications (13)

  • de Aguiar Vallim TQ, Tarling EJ, Edwards PA. Pleiotropic roles of bile acids in metabolism. Cell Metab. 2013 May 7;17(5):657-69. doi: 10.1016/j.cmet.2013.03.013. Epub 2013 Apr 18.

    PMID: 23602448RESULT

  • Guzior DV, Quinn RA. Review: microbial transformations of human bile acids. Microbiome. 2021 Jun 14;9(1):140. doi: 10.1186/s40168-021-01101-1.

    PMID: 34127070RESULT

  • Zhao X, Yang X, Hang HC. Chemoproteomic Analysis of Microbiota Metabolite-Protein Targets and Mechanisms. Biochemistry. 2022 Dec 20;61(24):2822-2834. doi: 10.1021/acs.biochem.1c00758. Epub 2022 Jan 6.

    PMID: 34989554RESULT

  • Pak HH, Cummings NE, Green CL, Brinkman JA, Yu D, Tomasiewicz JL, Yang SE, Boyle C, Konon EN, Ong IM, Lamming DW. The Metabolic Response to a Low Amino Acid Diet is Independent of Diet-Induced Shifts in the Composition of the Gut Microbiome. Sci Rep. 2019 Jan 11;9(1):67. doi: 10.1038/s41598-018-37177-3.

    PMID: 30635612RESULT

  • Tirosh A, Calay ES, Tuncman G, Claiborn KC, Inouye KE, Eguchi K, Alcala M, Rathaus M, Hollander KS, Ron I, Livne R, Heianza Y, Qi L, Shai I, Garg R, Hotamisligil GS. The short-chain fatty acid propionate increases glucagon and FABP4 production, impairing insulin action in mice and humans. Sci Transl Med. 2019 Apr 24;11(489):eaav0120. doi: 10.1126/scitranslmed.aav0120.

    PMID: 31019023RESULT

  • Kumar DP, Asgharpour A, Mirshahi F, Park SH, Liu S, Imai Y, Nadler JL, Grider JR, Murthy KS, Sanyal AJ. Activation of Transmembrane Bile Acid Receptor TGR5 Modulates Pancreatic Islet alpha Cells to Promote Glucose Homeostasis. J Biol Chem. 2016 Mar 25;291(13):6626-40. doi: 10.1074/jbc.M115.699504. Epub 2016 Jan 12.

    PMID: 26757816RESULT

  • Murphy EA, Velazquez KT, Herbert KM. Influence of high-fat diet on gut microbiota: a driving force for chronic disease risk. Curr Opin Clin Nutr Metab Care. 2015 Sep;18(5):515-20. doi: 10.1097/MCO.0000000000000209.

    PMID: 26154278RESULT

  • Singh RK, Chang HW, Yan D, Lee KM, Ucmak D, Wong K, Abrouk M, Farahnik B, Nakamura M, Zhu TH, Bhutani T, Liao W. Influence of diet on the gut microbiome and implications for human health. J Transl Med. 2017 Apr 8;15(1):73. doi: 10.1186/s12967-017-1175-y.

    PMID: 28388917RESULT

  • Wei M, Huang F, Zhao L, Zhang Y, Yang W, Wang S, Li M, Han X, Ge K, Qu C, Rajani C, Xie G, Zheng X, Zhao A, Bian Z, Jia W. A dysregulated bile acid-gut microbiota axis contributes to obesity susceptibility. EBioMedicine. 2020 May;55:102766. doi: 10.1016/j.ebiom.2020.102766. Epub 2020 May 11.

    PMID: 32408110RESULT

  • Wu S, Bhat ZF, Gounder RS, Mohamed Ahmed IA, Al-Juhaimi FY, Ding Y, Bekhit AEA. Effect of Dietary Protein and Processing on Gut Microbiota-A Systematic Review. Nutrients. 2022 Jan 20;14(3):453. doi: 10.3390/nu14030453.

    PMID: 35276812RESULT

  • FOLCH J, LEES M, SLOANE STANLEY GH. A simple method for the isolation and purification of total lipides from animal tissues. J Biol Chem. 1957 May;226(1):497-509. No abstract available.

    PMID: 13428781RESULT

  • Keller S, Jahreis G. Determination of underivatised sterols and bile acid trimethyl silyl ether methyl esters by gas chromatography-mass spectrometry-single ion monitoring in faeces. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Dec 25;813(1-2):199-207. doi: 10.1016/j.jchromb.2004.09.046.

    PMID: 15556534RESULT

  • Van Elswyk ME, Weatherford CA, McNeill SH. A Systematic Review of Renal Health in Healthy Individuals Associated with Protein Intake above the US Recommended Daily Allowance in Randomized Controlled Trials and Observational Studies. Adv Nutr. 2018 Jul 1;9(4):404-418. doi: 10.1093/advances/nmy026.

    PMID: 30032227RESULT

MeSH Terms

Interventions

Diet, High-Protein

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Maria del Rocio Guizar-Heredia, Master

    Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

    STUDY CHAIR

  • Armando R Tovar, Doctor

    Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

    PRINCIPAL INVESTIGATOR

  • Martha Guevara-Cruz, Doctor

    Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department of nutrition physiology

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 18, 2023

Study Start

August 1, 2023

Primary Completion

November 30, 2023

Study Completion

December 30, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)