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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Thailand
    • ChonBuri
      • Mueang, ChonBuri, Thailand, 20131
        • Faculty of Allied Health Sciences, Burapha University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Dietary supplement: Asparagus capsule
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.
Other: Placebo capsule
Placebo capsule is categorized as other.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Burapha University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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