NCT05215210

Brief Summary

The study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. Research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. The main study parameter is fasting levels of plasma glucose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

January 18, 2022

Last Update Submit

November 4, 2022

Conditions

Glucose, High BloodImpaired Glucose Tolerance

Keywords

bitter gourdpre-diabetesfasting blood glucose

Outcome Measures

Primary Outcomes (1)

  • change in fasting plasma glucose concentrations

    marker for glucose metabolism

    Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

Secondary Outcomes (5)

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

    Baseline (before supplementation (T0)) and after 12 weeks (T4)

  • change in HbA1c

    Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

  • change in insulin

    Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

  • change in HOMA-IR levels

    Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

  • change in HOMA-B levels

    Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

Other Outcomes (4)

  • change in ALAT

    Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

  • change in ASAT

    Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

  • change in eGFR

    Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

  • +1 more other outcomes

Study Arms (2)

Bitter-gourd

EXPERIMENTAL

dried bitter-gourd supplements

Other: Bitter-gourd

Cucumber

ACTIVE COMPARATOR

dried cucumber supplements

Other: Cucumber

Interventions

Bitter-gourdOTHER

12-week intervention of 3.6 grams of dried bitter-gourd supplements

Bitter-gourd
CucumberOTHER

12-week intervention of 3.6 grams of cucumber supplements

Cucumber

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 40-75yrs
  • BMI \>25 kg/m2
  • Having a fasting glucose \>6.1 mmol/L

You may not qualify if:

  • Use of medication/supplements that may influence the study results, such as metformin, gliclazide, glimepiride, tolbutamide, insulin, sitagliptin (DPP4 inhibitor), liraglutide (GLP-1 agonist), acarbose, repaglinide, pioglitazone, corticosteroids (systemically) , SGLT-2 inhibitors, (judged by our research physician)
  • Having a fasting glucose \>11.0 mmol/L
  • History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
  • History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
  • 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 ≥14 glasses (women) or \>21 glasses (men) of alcoholic beverages per week, on average
  • pregnant or lactating (self-reported)
  • Abuse of illicit drugs (soft- and hard 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sandra van der Haar, MSc

    Stichting Wageningen Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Supplements will be labeled A and B by a scientist who is not involved in this trial.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project leader clinical trials

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

March 23, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 7, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)