NCT07009756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

May 29, 2025

Last Update Submit

June 6, 2025

Conditions

Keywords

gut microbiomehypercholesterolemiacricketinsect

Outcome Measures

Primary Outcomes (2)

  • Change in Gut Microbiota Composition

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

    70 days

  • Short-Chain Fatty Acid (SCFA) Profiles

    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

    70 days

Secondary Outcomes (2)

  • Change in Blood Lipid Levels

    70 days

  • Adverse Events and Safety Monitoring

    70 days

Study Arms (2)

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.

Dietary Supplement: Cricket PowderOther: Placebo

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.

Dietary Supplement: Cricket PowderOther: Placebo

Interventions

Cricket PowderDIETARY_SUPPLEMENT

The intervention product is each serving of cricket powder, which contains 21.5 grams of house cricket (Acheta domesticus) powder blended with pumpkin powder, packed in a sachet. The powder is prepared under sterile conditions and heat-treated to ensure microbiological safety, in compliance with Thai public health regulations. Each serving of cricket powder will be consumed together with 32 grams of instant pork-flavored congee, serving as the food base. This intervention is distinguished by its use of whole cricket powder as a natural, food-based source of protein, chitin, and bioactive compounds, rather than isolated nutrients or supplements. Unlike many clinical studies that use encapsulated insect protein, purified chitin, or insect extracts, this study utilizes a whole-food approach, incorporating cricket powder into a culturally relevant format, congee, to reflect real-life dietary practices.

Cricket Powder First, Then PlaceboPlacebo First, Then Cricket Powder
PlaceboOTHER

32 grams of instant pork-flavored congee that does not contain cricket powder

Cricket Powder First, Then PlaceboPlacebo First, Then Cricket Powder

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition, Mahidol University

Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2025

First Posted

June 8, 2025

Study Start

March 15, 2024

Primary Completion

June 19, 2024

Study Completion

June 19, 2024

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations