- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07700368
Effect of Monosodium Glutamate on Microbiome-Derived Imidazole Propionate Production in Healthy Volunteers
The goal of this clinical trial is to learn whether dietary monosodium glutamate (MSG), a common food flavor enhancer, increases the blood level of a gut-microbiome-derived compound called imidazole propionate (ImP) in healthy adult volunteers. ImP is a compound made by gut bacteria from the amino acid histidine, and higher blood levels have been linked to problems with blood-sugar control. The main questions this trial aims to answer are:
Does taking MSG together with L-histidine increase blood ImP levels compared with taking a salt (sodium chloride) placebo together with L-histidine? How do blood ImP levels change over time in response to MSG and L-histidine taken together?
Researchers will compare a 7-day period of L-histidine plus MSG against a 7-day period of L-histidine plus sodium chloride (a salt placebo with matching sodium content) to see whether MSG changes blood ImP levels. Each participant completes both periods in random order and serves as their own comparison.
Participants will:
Take L-histidine capsules twice daily (morning and evening with meals) during two separate 7-day periods.
Dissolve either MSG powder or salt powder in water and drink it twice daily during each period, with the two periods separated by a 7-day break (washout).
Give a fasting blood sample at the start of the study and on day 7 of each period.
Optionally provide a stool sample at the end of each period. Complete a daily treatment diary and a follow-up phone call after the final sample.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Sam Light, PhD
- Telefonnummer: 773-702-3435
- E-Mail: samlight@uchicago.edu
Studienorte
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 60637
- Duchossois Family Institute, Knapp Center for Biomedical Discovery (KCBD), Room 4214
-
Kontakt:
- Sam Light
- Telefonnummer: 773-702-3435
- E-Mail: samlight@uchicago.edu
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Age 18 years or older
- No antibiotic use in the previous 3 months
Exclusion Criteria:
- Diagnosis of diabetes or prediabetes (any type)
- Inflammatory bowel disease or other gastrointestinal disorder
- Known allergy or intolerance to monosodium glutamate (MSG)
- Pregnancy or breastfeeding
- Current participation in another clinical trial
- High habitual dietary intake of MSG or histidine
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Sequence 1: L-histidine + MSG, then L-histidine + NaCl
Participants receive L-histidine (4 g/day) plus monosodium glutamate (MSG; 3 g/day) during the first 7-day treatment period, followed by a 7-day washout, then L-histidine (4 g/day) plus sodium chloride (NaCl; 940 mg/day) during the second 7-day treatment period.
L-histidine is taken as capsules (2 g morning, 2 g evening with meals); MSG and NaCl are dissolved in approximately 240 mL of water and taken twice daily (morning and evening with meals).
|
USP-grade L-histidine, 4 g/day, taken as capsules divided into 2 g in the morning and 2 g in the evening with meals, during each 7-day treatment period.
Administered in both treatment periods for all participants.
Food-grade monosodium glutamate, 3 g/day, provided as identical-appearing single-dose powder sachets divided into 1.5 g in the morning and 1.5 g in the evening, each dissolved in approximately 240 mL
USP-grade sodium chloride, 940 mg/day, provided as identical-appearing single-dose powder sachets divided into 470 mg in the morning and 470 mg in the evening, each dissolved in approximately 240 mL of water and taken with meals during the placebo treatment period.
The sodium content is matched to that of the 3 g/day MSG dose to isolate the effect of glutamate.
|
|
Experimental: Sequence 2: L-histidine + NaCl, then L-histidine + MSG
Participants receive L-histidine (4 g/day) plus sodium chloride (NaCl; 940 mg/day) during the first 7-day treatment period, followed by a 7-day washout, then L-histidine (4 g/day) plus monosodium glutamate (MSG; 3 g/day) during the second 7-day treatment period.
L-histidine is taken as capsules (2 g morning, 2 g evening with meals); MSG and NaCl are dissolved in approximately 240 mL of water and taken twice daily (morning and evening with meals).
|
USP-grade L-histidine, 4 g/day, taken as capsules divided into 2 g in the morning and 2 g in the evening with meals, during each 7-day treatment period.
Administered in both treatment periods for all participants.
Food-grade monosodium glutamate, 3 g/day, provided as identical-appearing single-dose powder sachets divided into 1.5 g in the morning and 1.5 g in the evening, each dissolved in approximately 240 mL
USP-grade sodium chloride, 940 mg/day, provided as identical-appearing single-dose powder sachets divided into 470 mg in the morning and 470 mg in the evening, each dissolved in approximately 240 mL of water and taken with meals during the placebo treatment period.
The sodium content is matched to that of the 3 g/day MSG dose to isolate the effect of glutamate.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Difference in blood imidazole propionate concentration between the monosodium glutamate and sodium chloride treatment periods
Zeitfenster: Day 7 of each treatment period
|
Blood imidazole propionate concentration measured by liquid chromatography-mass spectrometry (LC-MS) from the blood sample collected on day 7 of each 7-day treatment period.
The outcome is the within-participant difference between the day-7 concentration following the L-histidine + MSG period and the day-7 concentration following the L-histidine + NaCl period.
|
Day 7 of each treatment period
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB25-1212
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Gesunder Erwachsener
-
Abramson Cancer Center at Penn MedicineAktiv, nicht rekrutierendAdolescent and Young Adult (AYA) KrebsüberlebendeVereinigte Staaten
-
St. Boniface HospitalHeart and Stroke Foundation of CanadaRekrutierungErnährung schlecht | Kardiovaskuläre Morbidität | Gebrechliches Syndrom älterer ErwachsenerKanada
-
Wake Forest University Health SciencesAbgeschlossenKritische Krankheit | Akuter Atemstillstand | ErwachsenensyndromVereinigte Staaten
-
Georgetown UniversityNoch keine RekrutierungPrädiabetes | Postmenopausal | Adolescent and Young Adult (AYA) Krebsüberlebende
-
Central Hospital, Nancy, FranceAbgeschlossenSchwer krank | Adult-Onset-Still-KrankheitFrankreich
-
Second Xiangya Hospital of Central South UniversityRekrutierung
-
Central Hospital, Nancy, FranceAbgeschlossen
-
Novartis PharmaceuticalsRekrutierungFamiliäres Mittelmeerfieber | Systemische juvenile idiopathische Arthritis | Immer noch Krankheit | Adult-Onset-Still-KrankheitSchweiz
-
Swedish Orphan BiovitrumAbgeschlossenArthritis, juvenil | Lymphohistiozytose, Hämophagozytose | Makrophagenaktivierungssyndrom | Adult Onset Still DiseaseVereinigte Staaten, Spanien, Vereinigtes Königreich, Frankreich, Italien
-
Yale UniversityRheumatology Research FoundationRekrutierungRheumatische Erkrankungen | Rheumatoide Arthritis | Systemischer Lupus erythematodes | Systemische Sklerose | Dermatomyositis | Polymyositis | Riesenzellarteriitis | Polymyalgia rheumatica | Psoriasis-Arthritis | Sjögren-Syndrom | Antiphospholipid-Syndrom | Sarkoidose | Lyme-Borreliose | Spondylitis ankylosans | Sk... und andere BedingungenVereinigte Staaten
Klinische Studien zur L-histidine
-
Wake Forest University Health SciencesZurückgezogenAlzheimer ErkrankungVereinigte Staaten
-
Lawson Health Research InstituteAktiv, nicht rekrutierend
-
Fundació EurecatCentre de Diagnosi per la Imatge; Instituto de Investigación Biomédica de Girona... und andere MitarbeiterAbgeschlossenViszerale Fettleibigkeit | Alkoholfreie Fettleber | PostmenopausalSpanien
-
University of OregonNational Institute on Aging (NIA); Oregon Health and Science University; University... und andere MitarbeiterAbgeschlossenLebensqualität | MuskelatrophieVereinigte Staaten
-
Cornell UniversityAbgeschlossen
-
McMaster UniversityAbgeschlossenReizdarmsyndromKanada
-
Fundació EurecatCentre de Diagnosi per la Imatge; Laboratorio de Referencia Sud; Centro OWLiverAbgeschlossenNicht alkoholische Fettleber | Viszerale FettleibigkeitSpanien
-
Ospedale di Circolo - Fondazione MacchiAbgeschlossenAmbulante chirurgische Eingriffe | Anästhesie, Wirbelsäule | PrilocainItalien
-
Jing-yuan Fang, MD, Ph. DShanghai Punan Hospital of Pudong New DistrictNoch keine Rekrutierung
-
University of MiamiZurückgezogen