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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Sam Light, PhD
- Numero di telefono: 773-702-3435
- Email: samlight@uchicago.edu
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60637
- Duchossois Family Institute, Knapp Center for Biomedical Discovery (KCBD), Room 4214
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Contatto:
- Sam Light
- Numero di telefono: 773-702-3435
- Email: samlight@uchicago.edu
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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).
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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.
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Sperimentale: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Difference in blood imidazole propionate concentration between the monosodium glutamate and sodium chloride treatment periods
Lasso di tempo: Day 7 of each treatment period
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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.
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Day 7 of each treatment period
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB25-1212
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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