Asparagus Capsule Consumption and Blood Sugar and Lipids and Oxidative Stress

NCT06195813 | Completed Phase 2 DMC

• 1 other identifier: IRB3-115/2565
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Asparagus Capsule Consumption

Outcome Measures

Primary Outcomes (8)

• Level of body fat

  Level of body fat was measured in percentage unit

  Day 0 and end of 12 weeks

• Level of fat mass

  Level of fat mass was measured in kilogram unit

  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)

  Day 0 and end of 12 weeks

• Concentration of blood glucose

  Concentration of blood glucose was measured in serum in mmol/L unit

  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

  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

  Day 0 and end of 12 weeks

• Concentration of blood malondialdehyde

  Concentration of blood malondialdehyde was measured in plasma in uM (micromolar) unit

  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

  Day 0 and end of 12 weeks

Secondary Outcomes (1)

• Concentrations of blood glucose from oral glucose tolerance test

  At 0 minute before glucose consumption and at 30, 60, 90, 120 minutes after glucose consumption

Study Arms (2)

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.

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.

Other: Placebo capsule

Interventions

Asparagus capsule DIETARY_SUPPLEMENT

Asparagus capsule is categorized as dietary supplement.

Asparagus capsule

Placebo capsule OTHER

Placebo capsule is categorized as other.

Placebo capsule

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- Current signs or symptoms of infection, i.e., fever, hyperpnea, dyspnea, and palpitations.

Sponsors & Collaborators

• Burapha University: lead

Study Sites (1)

Faculty of Allied Health Sciences, Burapha University

Mueang, Changwat Chon Buri, 20131, Thailand

Location

Study Officials

• Piyapong Prasertsri, Ph.D.

  Burapha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: Participants were randomly divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups.

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 8, 2024
• Study Start: December 20, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)