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临床试验/NCT05456672
NCT05456672已完成不适用

Investigation of the Impact of Food Combination Strategies on Postprandial Blood Glucose Responses

Hospital de Santo Espírito4 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
4
主要终点
Glycemic response

研究概览

简要总结

The purpose of this study is to assess the impact of combining starch rich foods with low pH foods on the glycemic response to meals

详细描述

Low pH foods can attenuate the glycemic response to starch-rich foods. It has been demonstrated that lemon juice, due to its low pH (pH≈2.3) inhibited key digestive enzymes thereby interrupting gastric digestion of starch in vitro. This effect can significantly reduce the glycemic response in humans. In particular, adding lemon juice to a starch rich meal reduced the mean blood glucose concentration peak by 30%.

Considering the panoply of food options available, it is likely that other combinations have similar effects but no work has been conducted to develop a consolidated knowledge base to exploit this strategy. GlucoMatchMaker will go beyond the state-of-the art by addressing this knowledge gap. The main goal is to develop and test the real-life impact of pH-based food combination strategies on glycemic responses.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject has given written informed consent
  • Subject is available to participate in the study sessions on the proposed dates.

排除标准

  • Subject has an allergy or intolerance to any food and/or ingredient in the study meals
  • Body mass index ≤ 18.5 kg/m2 or ≥ 30.0 kg/m
  • Diagnosed mouth, throat or active gastrointestinal pathology that may affect normal ingestion and digestion of food.
  • History of pancreatic disease
  • Subject is immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year).
  • Subject has Type 1 or Type 2 diabetes mellitus or pre-diabetes.
  • Subject has a history of drug and/or alcohol abuse at the time of enrolment.
  • Subject is currently taking medication that can effect glucose metabolism and/or normal gastrointestinal function.
  • Subject is currently participating in another study, or plans to participate in another study during the study period.
  • Women of child-bearing potential who do not use an acceptable method of contraception.
  • Pregnant or nursing (lactating) women.

结局指标

主要结局

Glycemic response

时间窗: 12 days

Measurement of postprandial glucose concentrations

次要结局

  • Adherence to food combination recommendations(3 days)
  • Dietary patterns(Baseline)
  • Composition of non standardized meals(10 days)
  • AMY 1 copy number(Baseline)
  • Salivary alpha-amylase activity(Baseline)

研究者

发起方
Hospital de Santo Espírito
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Freitas

Dr

Hospital de Santo Espírito

研究点 (4)

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