- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06195813
Asparagus Capsule Consumption and Blood Sugar and Lipids and Oxidative Stress
January 10, 2024 updated by: Piyapong Prasertsri, Burapha University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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ChonBuri
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Mueang, ChonBuri, Thailand, 20131
- Faculty of Allied Health Sciences, Burapha University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Current signs or symptoms of infection, i.e., fever, hyperpnea, dyspnea, and palpitations.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Asparagus capsule
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.
|
Asparagus capsule is categorized as dietary supplement.
|
|
Placebo Comparator: Placebo capsule
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.
|
Placebo capsule is categorized as other.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of body fat
Time Frame: Day 0 and end of 12 weeks
|
Level of body fat was measured in percentage unit
|
Day 0 and end of 12 weeks
|
|
Level of fat mass
Time Frame: Day 0 and end of 12 weeks
|
Level of fat mass was measured in kilogram unit
|
Day 0 and end of 12 weeks
|
|
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)
|
Day 0 and end of 12 weeks
|
|
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
|
Day 0 and end of 12 weeks
|
|
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
|
Day 0 and end of 12 weeks
|
|
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
|
Day 0 and end of 12 weeks
|
|
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
|
Day 0 and end of 12 weeks
|
|
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
|
Day 0 and end of 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Concentrations of blood glucose were measured before and after glucose consumption at 75 g/100 ml in mg/dL unit
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At 0 minute before glucose consumption and at 30, 60, 90, 120 minutes after glucose consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Piyapong Prasertsri, Ph.D., Burapha University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2022
Primary Completion (Actual)
September 14, 2023
Study Completion (Actual)
September 14, 2023
Study Registration Dates
First Submitted
December 21, 2023
First Submitted That Met QC Criteria
January 5, 2024
First Posted (Actual)
January 8, 2024
Study Record Updates
Last Update Posted (Actual)
January 12, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- IRB3-115/2565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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