Asparagus Capsule ConsumptionPhase 2NCT06195813
Asparagus Capsule Consumption and Blood Sugar and Lipids and Oxidative Stress
A Phase 2 study testing Asparagus capsule in people with Asparagus Capsule Consumption, run by Burapha University at 1 site in Thailand.
Trial summary
Participants were 44 overweight and obese persons, male and female, age 18-59 years. Participants were divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Asparagus Capsule Consumption
- What is being tested?
- Asparagus capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteThailand
- Study dates
- 20 Dec 2022to 14 Sep 2023
- Phase
- Phase 2
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man or woman, aged between 18 to 59 years
- Body mass index more than 23 (Asian criteria)
- No history of hypertension, diabetes, cardiovascular disease, respiratory disease, endocrine disease, neuromuscular disease, musculoskeletal disease, liver disease, renal disease, immune disease, infectious disease, or cancer
- No regular intake of dietary supplements, i.e., vitamins, antioxidants
- No regular smokers or alcohol drinkers (>2 times per week)
- Not sportman or regular exerciser (>2 times per week or >150 min per week)
- No food allergy, especially shoot
Who cannot join
- Current signs or symptoms of infection, i.e., fever, hyperpnea, dyspnea, and palpitations.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Allied Health Sciences, Burapha University
Mueang, Changwat Chon Buri, 20131
About this study
Official title: Effects of Asparagus Capsule Consumption on Blood Sugar and Lipids and Oxidative Stress in Overweight and Obese Participants
Participants were 44 overweight and obese persons, male and female, age 18-59 years. Participants were divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups. They received health screenings including history taking, mental health questionnaire, and vital signs, height and body weight, body composition, fat distribution measurements and oral glucose tolerance test. Then, a venipuncture was conducted to determine blood glucose, insulin, lipids malondialdehyde and protein carbonyl levels.
Read the detailed description
The study design was cross-sectional. Participants were 44 overweight and obese persons, male and female, age 18-59 years. Participants were divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups. They received health screenings including history taking, mental health questionnaire, and vital signs, height and body weight, body composition, fat distribution measurements and oral glucose tolerance test. Then, a venipuncture was conducted to determine blood glucose, insulin, lipids malondialdehyde and protein carbonyl levels. Analysis of covariance was used to analyze parameters between groups and paired t-test was used to analyze parameters intra-group.
- Conditions
- Asparagus Capsule Consumption
- Being tested
- Asparagus capsule, Placebo capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asparagus capsuleDietary supplement
Asparagus capsule is categorized as dietary supplement.
Placebo capsuleOther
Placebo capsule is categorized as other.
| Study group | Role | What they receive |
|---|---|---|
| Asparagus capsule | Experimental | Participants were randomized to receive an arm. In this arm, participants received asparagus capsule and were asked to consume at 40 mg/kg (1-2 capsule) within 15-30 min after breakfast. Consumption was taken at participants' dwelling. Receives: Dietary Supplement: Asparagus capsule |
| Placebo capsule | Placebo comparator | Participants were randomized to receive an arm. In this arm, participants received placebo capsule and were asked to consume at 40 mg/kg (1-2 capsule) within 15-30 min after breakfast. Consumption was taken at participants' dwelling. Receives: Other: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of body fat
Level of body fat was measured in percentage unit
Measured: Day 0 and end of 12 weeks
Level of fat mass
Level of fat mass was measured in kilogram unit
Measured: Day 0 and end of 12 weeks
Level of fat distribution
Level of fat distribution was measured by ratio of waist (centimeter) to hip (centimeter)
Measured: Day 0 and end of 12 weeks
Concentration of blood glucose
Concentration of blood glucose was measured in serum in mmol/L unit
Measured: Day 0 and end of 12 weeks
Concentration of blood insulin
Concentration of blood insulin was measured in serum in uU/mL (microunit/milliliter) unit
Measured: Day 0 and end of 12 weeks
Concentrations of blood lipids
Concentrations of total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol were measured in serum in mg/dL unit
Measured: Day 0 and end of 12 weeks
Concentration of blood malondialdehyde
Concentration of blood malondialdehyde was measured in plasma in uM (micromolar) unit
Measured: Day 0 and end of 12 weeks
Concentration of blood protein carbonyl
Concentration of blood protein carbonyl was measured in plasma in nmol/mg protein unit
Measured: Day 0 and end of 12 weeks
Secondary outcomes (1)
Concentrations of blood glucose from oral glucose tolerance test
Concentrations of blood glucose were measured before and after glucose consumption at 75 g/100 ml in mg/dL unit
Measured: At 0 minute before glucose consumption and at 30, 60, 90, 120 minutes after glucose consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start20 Dec 2022
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asparagus Capsule ConsumptionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burapha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piyapong Prasertsri, Burapha University
- Investigators
- Piyapong Prasertsri, Ph.D., Principal investigator, Burapha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195813
- Sponsor's protocol ID
- IRB3-115/2565
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Asparagus Capsule Consumption on Blood Sugar and Lipids and Oxidative Stress in Overweight and Obese Participants
- ClinicalTrials.gov ID
- NCT06195813
- Acronym / sponsor ID
- IRB3-115/2565
- Conditions
- Asparagus Capsule Consumption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Burapha UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 8 Jan 2024 (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.
Participants were 44 overweight and obese persons, male and female, age 18-59 years. Participants were divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups. They received health screenings including history taking, mental health questionnaire, and vital signs, height and body weight, body composition, fat distribution measurements and oral glucose tolerance test. Then, a venipuncture was conducted to determine blood glucose, insulin, lipids malondialdehyde and protein carbonyl levels.
Detailed description
The study design was cross-sectional. Participants were 44 overweight and obese persons, male and female, age 18-59 years. Participants were divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups. They received health screenings including history taking, mental health questionnaire, and vital signs, height and body weight, body composition, fat distribution measurements and oral glucose tolerance test. Then, a venipuncture was conducted to determine blood glucose, insulin, lipids malondialdehyde and protein carbonyl levels. Analysis of covariance was used to analyze parameters between groups and paired t-test was used to analyze parameters intra-group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups.
| Arm | Type | Receives |
|---|---|---|
| Asparagus capsule | Experimental | Dietary Supplement: Asparagus capsuleParticipants were randomized to receive an arm. In this arm, participants received asparagus capsule and were asked to consume at 40 mg/kg (1-2 capsule) within 15-30 min after breakfast. Consumption was taken at participants' dwelling. |
| Placebo capsule | Placebo comparator | Other: Placebo capsuleParticipants were randomized to receive an arm. In this arm, participants received placebo capsule and were asked to consume at 40 mg/kg (1-2 capsule) within 15-30 min after breakfast. Consumption was taken at participants' dwelling. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Man or woman, aged between 18 to 59 years
- Body mass index more than 23 (Asian criteria)
- No history of hypertension, diabetes, cardiovascular disease, respiratory disease, endocrine disease, neuromuscular disease, musculoskeletal disease, liver disease, renal disease, immune disease, infectious disease, or cancer
- No regular intake of dietary supplements, i.e., vitamins, antioxidants
- No regular smokers or alcohol drinkers (>2 times per week)
Key exclusion criteria (1 listed)
- Current signs or symptoms of infection, i.e., fever, hyperpnea, dyspnea, and palpitations.
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 |
|---|---|---|
| Asparagus capsuleAsparagus capsule is categorized as dietary supplement. | Dietary supplement | Asparagus capsule |
| Placebo capsulePlacebo capsule is categorized as other. | Other | Placebo capsule |
Primary outcome
Level of body fat
Time frame: Day 0 and end of 12 weeks
Level of body fat was measured in percentage unit
Level of fat mass
Time frame: Day 0 and end of 12 weeks
Level of fat mass was measured in kilogram unit
Level of fat distribution
Time frame: Day 0 and end of 12 weeks
Level of fat distribution was measured by ratio of waist (centimeter) to hip (centimeter)
Concentration of blood glucose
Time frame: Day 0 and end of 12 weeks
Concentration of blood glucose was measured in serum in mmol/L unit
Concentration of blood insulin
Time frame: Day 0 and end of 12 weeks
Concentration of blood insulin was measured in serum in uU/mL (microunit/milliliter) unit
Concentrations of blood lipids
Time frame: Day 0 and end of 12 weeks
Concentrations of total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol were measured in serum in mg/dL unit
Concentration of blood malondialdehyde
Time frame: Day 0 and end of 12 weeks
Concentration of blood malondialdehyde was measured in plasma in uM (micromolar) unit
Concentration of blood protein carbonyl
Time frame: Day 0 and end of 12 weeks
Concentration of blood protein carbonyl was measured in plasma in nmol/mg protein unit
1 secondary outcome
Concentrations of blood glucose from oral glucose tolerance test
Time frame: At 0 minute before glucose consumption and at 30, 60, 90, 120 minutes after glucose consumption
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 12 Jan 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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.
Piyapong Prasertsri, Ph.D. principal investigator
Burapha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asparagus capsule in people with Asparagus Capsule Consumption, run by Burapha 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 7 inclusion and 1 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 12 Jan 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Level of body fat (time frame: Day 0 and end of 12 weeks). The study lists 8 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 12 Jan 2024.