The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

NCT04090788 | Completed

• 1 other identifier: NL70259.081.19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized, cross-over, double blind, controlled trial in which study participants will receive two 4-week interventions with a washout period of 4 weeks between interventions. Study subjects will visit the research facility before and after each intervention period for a test day. In the third intervention week participants are provided with a 3-day controlled diet and glucose responses will be monitored via a continuous glucose monitoring device.

Conditions

Glucose Intolerance

Keywords

bitter gourd; pre-diabetics; glucose response

Outcome Measures

Primary Outcomes (2)

• change in fasting plasma glucose concentrations

  marker for glucose metabolism

  before (Week 0) and after 4 weeks of supplement intervention

• change in 2hour plasma glucose concentrations after a 75-gram OGTT

  marker for glucose metabolism

  before (Week 0) and after 4 weeks of supplement intervention

Secondary Outcomes (5)

• change in HbA1c

  before (Week 0) and after 4 weeks of supplement intervention

• change in fructosamine

  before (Week 0) and after 4 weeks of supplement intervention

• change in fasting insulin

  before (Week 0) and after 4 weeks of supplement intervention

• change in 2hour plasma insulin concentrations after a 75-gram OGTT

  before (Week 0) and after 4 weeks of supplement intervention

• Change in postprandial glucose concentrations after food intake

  Three full days, in the third week of the supplement intervention

Other Outcomes (5)

• change in triglycerides (TAG) concentration

  before (Week 0) and after 4 weeks of supplement intervention

• change in cholesterol

  before (Week 0) and after 4 weeks of supplement intervention

• change in ALAT

  before (Week 0) and after 4 weeks of supplement intervention

Study Arms (2)

dried bitter-gourd supplements

EXPERIMENTAL

2.4 gram per day for 4 weeks

Dietary Supplement: dried bitter-gourd supplements

dried cucumber supplements

ACTIVE COMPARATOR

2.4 gram per day for 4 weeks

Dietary Supplement: dried cucumber supplements

Interventions

dried bitter-gourd supplements DIETARY_SUPPLEMENT

intervention with 2.4g/d dried bitter-gourd supplements

Also known as: Momordica charantia

dried bitter-gourd supplements

dried cucumber supplements DIETARY_SUPPLEMENT

reference intervention with 2.4g/d dried cucumber supplements

dried cucumber supplements

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 50-75yrs
• BMI \>25 kg/m2
• Having veins suitable for blood sampling via a catheter
• Having one or more of the following criteria:
• HbA1c \> 5.7%
• fasting glucose \>5.6mmol/L
• two-hour glucose levels \>7.8 mmol/L on the 75-g oral glucose tolerance test .

You may not qualify if:

• History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
• History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
• Kidney dysfunction (self-reported)
• Use of medication/supplements that may influence the study results, such as medicines known to interfere with glucose homeostasis.
• Anaemia (Hb values \<7.5 for women and \<8.5 for men)
• Reported slimming, medically prescribed or other extreme diets
• Reported weight loss or weight gain of \> 5 kg in the month prior to pre-study screening
• Not willing to give up blood donation during the study
• Current smokers
• Alcohol intake ≥4 glasses of alcoholic beverages per day
• Abuse of illicit drugs
• Food allergies for products that we use in the study
• Participation in another clinical trial at the same time
• Being an employee of the Food, Health \& Consumer Research group of Wageningen Food \& Biobased Research or dept. human nutrition and health of Wageningen University.

Sponsors & Collaborators

• Wageningen University and Research: lead

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader clinical trials

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 16, 2019
• Study Start: September 17, 2019
• Primary Completion: December 24, 2019
• Study Completion: December 25, 2019
• Last Updated: October 12, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)