HypercholesterolemiaCricketOnMENCT07009756
How Cricket Powder Affects Gut Microbiome and Cholesterol Metabolism
A study testing Cricket Powder in people with Hypercholesterolemia, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Cricket Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteThailand
- Study dates
- 15 Mar 2024to 19 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Institute of Nutrition, Mahidol University
Nakhon Pathom, 73170
About this study
Official title: Impact of Dietary Supplementation With Cricket Powder on Intestinal Microbiota and Cholesterol Metabolism
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.
- Conditions
- Hypercholesterolemia
- Being tested
- Cricket Powder, Placebo
- Keywords
- gut microbiome, hypercholesterolemia, cricket, insect
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
32 grams of instant pork-flavored congee that does not contain cricket powder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Cricket Powder; Other: 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. Receives: Dietary Supplement: Cricket Powder; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 70 days
Secondary outcomes (2)
Change in Blood Lipid Levels
Measurement of serum lipid profiles, including total cholesterol, LDL-C, HDL-C, and triglycerides, to evaluate the effect of cricket powder on lipid metabolism
Measured: 70 days
Adverse Events and Safety Monitoring
Assessment of adverse effects through participant self-report, clinical observation, and relevant laboratory parameters to evaluate the safety of daily cricket powder consumption
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start15 Mar 2024
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009756
- Sponsor's protocol ID
- MU-MOU 2023-334.2710
- Other IDs
- MU-MOU 2023-334.2710
- Acronym
- CricketOnME
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Supplementation With Cricket Powder on Intestinal Microbiota and Cholesterol Metabolism
- ClinicalTrials.gov ID
- NCT07009756
- Acronym / sponsor ID
- CricketOnME / MU-MOU 2023-334.2710
- Conditions
- Hypercholesterolemia
- Keywords
- gut microbiome, hypercholesterolemia, cricket, insect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cricket Powder First, Then Placebo | Experimental | Dietary Supplement: Cricket Powder, Other: PlaceboParticipants 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. |
| Placebo First, Then Cricket Powder | Experimental | Dietary Supplement: Cricket Powder, Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cricket PowderThe 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. | Dietary supplement | Cricket Powder First, Then Placebo, Placebo First, Then Cricket Powder |
| Placebo32 grams of instant pork-flavored congee that does not contain cricket powder | Other | Cricket Powder First, Then Placebo, Placebo First, Then Cricket Powder |
Primary outcome
Change in Gut Microbiota Composition
Time frame: 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
Time frame: 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
2 secondary outcomes
Change in Blood Lipid Levels
Time frame: 70 days
Adverse Events and Safety Monitoring
Time frame: 70 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cricket Powder in people with Hypercholesterolemia, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut Microbiota Composition (time frame: 70 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.