Effect of Monosodium Glutamate on Microbiome-Derived Imidazole Propionate Production in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Difference in blood imidazole propionate concentration between the monosodium glutamate and sodium chloride treatment periods
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •No antibiotic use in the previous 3 months
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Monosodium glutamate (MSG) (Dietary Supplement)
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).
干预措施: L-histidine (Dietary Supplement)
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).
干预措施: Sodium chloride (NaCl) (Dietary Supplement)
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).
干预措施: Monosodium glutamate (MSG) (Dietary Supplement)
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).
干预措施: L-histidine (Dietary Supplement)
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).
干预措施: Sodium chloride (NaCl) (Dietary Supplement)
结局指标
主要结局
Difference in blood imidazole propionate concentration between the monosodium glutamate and sodium chloride treatment periods
时间窗: 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.
次要结局
未报告次要终点