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临床试验/NCT07009756
NCT07009756已完成不适用

Impact of Dietary Supplementation With Cricket Powder on Intestinal Microbiota and Cholesterol Metabolism

Mahidol University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Change in Gut Microbiota Composition

研究概览

简要总结

Cardiovascular disease (CVD) is the leading cause of death worldwide, including in Thailand. One of the major risk factors for CVD is dyslipidemia, or abnormal levels of cholesterol and other fats in the blood. Recent research suggests that the balance of gut microbiota, the community of microorganisms living in the digestive system, may play a key role in regulating cholesterol levels and overall metabolism.

This study explored the potential health benefits of cricket powder, a high-protein food that is already safely consumed in many parts of the world. Previous studies have shown that cricket powder may increase the number of beneficial gut bacteria, especially Bifidobacterium animalis, which supports the production of short-chain fatty acids (SCFAs) known to improve fat metabolism.

Although crickets are considered safe to eat, more research is needed to understand their effects on gut health and blood cholesterol, especially in people with high cholesterol levels. This study assessed the safety of cricket powder consumption and whether it can help improve gut microbiota balance and lower cholesterol in Thai adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy, aged in the 20 - 60 range
  • •BMI (Body Mass Index) in the range of 18.5 - 29.9 kg/m2
  • •No underlying diseases
  • •No gastrointestinal surgery
  • •The fasting blood parameters of total cholesterol and LDL-C are higher than 200 mg/dL and 130 - 189 mg/dL, respectively.
  • •The fasting blood triglyceride must be less than 500 mg/dL.
  • •The fasting blood glucose must be less than 110 mg/dL.
  • •ALT (Alanine aminotransferase) and AST (Aspartate aminotransferase) must be less than 60 units/L.
  • •eGFR (estimated glomerular filtration rate) must be at least 90 mL/min/1.73 m
  • •Blood pressure must be less than 160/90 mmHg.
  • •Heart rate must be less than 100 times/minute.
  • •No smoking
  • •Be able to consume pork congee

排除标准

  • •Allergic to insects, chitin, chitosan, shrimp, dust mites, and other crustacean products
  • •Pregnant or breastfeeding
  • •Participating in other research projects, and receiving drugs, herbs, and supplements
  • •Receiving steroid, antibiotic, or other drugs that may affect lipid metabolism
  • •Consuming alcohol more than 2 drinks per day e.g., beer of 24 ounces, wine of 10 ounces, and distilled spirits of 3 ounces
  • •Regularly consuming probiotic products and cannot stop consuming them
  • •Having histories of diabetes, chronic liver diseases, chronic kidney diseases, cardiovascular diseases, cancer, anemia, irritable bowel syndrome, ulcerative colitis, or anaphylaxis

研究组 & 干预措施

Cricket Powder First, Then Placebo

Experimental

Participants in this arm will consume a daily serving of cricket powder congee for 21 consecutive days, followed by a 28-day washout period, and then consume a daily serving of placebo congee (pork congee) for another 21 consecutive days.

干预措施: Cricket Powder (Dietary Supplement)

Cricket Powder First, Then Placebo

Experimental

Participants in this arm will consume a daily serving of cricket powder congee for 21 consecutive days, followed by a 28-day washout period, and then consume a daily serving of placebo congee (pork congee) for another 21 consecutive days.

干预措施: Placebo (Other)

Placebo First, Then Cricket Powder

Experimental

Participants in this arm will consume a daily serving of placebo congee (pork congee) for 21 consecutive days, followed by a 28-day washout period, and then consume a daily serving of cricket powder congee for another 21 consecutive days.

干预措施: Cricket Powder (Dietary Supplement)

Placebo First, Then Cricket Powder

Experimental

Participants in this arm will consume a daily serving of placebo congee (pork congee) for 21 consecutive days, followed by a 28-day washout period, and then consume a daily serving of cricket powder congee for another 21 consecutive days.

干预措施: Placebo (Other)

结局指标

主要结局

Change in Gut Microbiota Composition

时间窗: 70 days

Assessed by analyzing stool samples using 16S rRNA gene sequencing to evaluate changes in the relative abundance and diversity of gut microbiota

Short-Chain Fatty Acid (SCFA) Profiles

时间窗: 70 days

Quantification of fecal SCFA concentrations (e.g., acetate, propionate, and butyrate) using gas chromatography and metabolomic analysis to assess microbial metabolic activity and functional output

次要结局

  • Change in Blood Lipid Levels(70 days)
  • Adverse Events and Safety Monitoring(70 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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