Modulation of Secondary Bile Acids Through the Intestinal Microbiota After Consumption of a High-protein Diet.
NCT ID: NCT05906641
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2023-08-01
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
High-protein diet
Protein intake will be increased to be 30% calories from protein with calcium caseinate.
Interventions
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High-protein diet
Protein intake will be increased to be 30% calories from protein with calcium caseinate.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
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Armando Tovar
Head of department of nutrition physiology
Principal Investigators
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Maria del Rocio Guizar-Heredia, Master
Role: STUDY_CHAIR
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Armando R Tovar, Doctor
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Martha Guevara-Cruz, Doctor
Role: STUDY_DIRECTOR
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Locations
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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Mexico City, , Mexico
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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4532
Identifier Type: -
Identifier Source: org_study_id
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