Clinical trial NCT07009756: How Cricket Powder Affects Gut Microbiome and Cholesterol Metabolism
Official title: Impact of Dietary Supplementation With Cricket Powder on Intestinal Microbiota and Cholesterol Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: gut microbiome
hypercholesterolemia
cricket
insect
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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 m2.
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Gut Microbiota Composition
timeFrame: 70 days
measure: Short-Chain Fatty Acid (SCFA) Profiles
timeFrame: 70 days
Secondary outcomes:
measure: Change in Blood Lipid Levels
timeFrame: 70 days
measure: Adverse Events and Safety Monitoring
timeFrame: 70 days
Other outcomes:
Locations:
city: Nakhon Pathom
country: Thailand
facility: Institute of Nutrition, Mahidol University
Study officials:
References: