An Alternative Approach to Improve Hyperglycemia Among Type 2 Diabetes Patients

Effects of Bitter Melon Intake and Moderate-Intensity Physical Activity on Postprandial Glucose Responses in Type 2 Diabetic Patients

The study compared the effect of bitter melon intake and moderate exercise on postprandial glucose levels as measured by incremental area under the curve (iAUC) in eight patients with type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Dietary supplement: Bitter melon juice (100 ml); Behavioral: Exercise

Detailed Description

Background: This study compared the effects of bitter melon intake and moderate-intensity physical activity on postprandial glucose responses in type 2 diabetic patients.

Methods: A total of 8 patients with type 2 diabetes were randomly assigned to two sequences (AB, BA) with two treatments (A or B) using a 2 x 2 randomized cross-over design: A) 100 ml of bitter melon juice administered 15 minutes prior to the 75-g oral glucose load; B) 30 minutes walking at moderate-intensity performed 15 minutes after the oral glucose load.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• An age of 20 to 79 years
• Physician-diagnosed type 2 diabetes
• Medical clearance for physical activity from their healthcare provider

Exclusion Criteria:

• Pregnant or were receiving insulin treatment
• An allergy to bitter melon
• Medical conditions that impacted the normal the functioning of the gastrointestinal tract
• Contraindications to physical activity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bitter Melon; The participants were asked to consume 100 ml of bitter melon juice 15 minutes prior to the 75-g oral glucose intake. Participants drank the juice within 5 minutes. Participants remained seated throughout the following 2 hours.	Dietary supplement: Bitter melon juice (100 ml); Fresh bitter melon fruits were purchased from certified local groceries. The seeds of bitter melon were removed, and the juice was obtained from the raw fruit using a blender. Every 140 g of bitter melon fruit produced approximately 100 ml bitter melon juice.
Experimental: Exercise; Participants performed 30 minutes of treadmill walking at 65% of the age-predicted maximum heart rate. The exercise started 15 minutes after the 75-g oral glucose intake.	Behavioral: Exercise; The walking exercise was started 15 minutes after the glucose load. Walking speed was determined to elicit 65% of the maximum heart rate (HRmax) during exercise for each participant. HRmax was estimated using the America College of Cardiology prediction model, HRmax=208 - 0.7 × age. All participants wore a heart rate monitor (Polar, Vantage, XL) around the chest to assess exercise intensity. A rate of perceived exertion was assessed every 2 minutes based on the Borg's scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean glucose	mean glucose values	2-hour postprandial period
incremental area under the curve	2-hour postprandial glucose incremental area under the curve	2-hour postprandial period

Collaborators and Investigators

• Sponsor: Arizona State University
• Investigators: Principal Investigator: Chong Lee, Ph.D., Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2016
• Primary Completion (Actual): August 20, 2016
• Study Completion (Actual): September 20, 2016

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY00004172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No