NCT04233281

Brief Summary

The study is a randomized, cross-over, double blind, controlled trial in which study participants will visit the research facility on two occasions under fasting conditions with a minimum of 1 week between visits. During each visit, participants will receive a carbohydrate rich test-meal with Kori-tofu (protein) or whey protein. The two meals will be given in randomized order and blood will be collected via a catheter before and up to 3 hours after consumption of the test-meal. Study participants will also wear continuous glucose meters during the trial. They will receive a standardized evening meal prior to each study day and are asked not to drink alcohol or perform heavy exercise the day before. After each test day participants are offered a meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

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

Study Start

First participant enrolled

January 6, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

January 14, 2020

Last Update Submit

March 25, 2020

Conditions

Glucose Intolerance

Keywords

Kori tofuGlucose responsePre-diabetics

Outcome Measures

Primary Outcomes (1)

  • change in blood glucose levels after a carbohydrate rich meal

    postprandial test, determine glucose levels in blood samples collected before and after the test meal

    blood samples will be taken before and up to 3 hours after test meal consumption

Secondary Outcomes (2)

  • change in blood insulin levels after a carbohydrate rich meal

    blood samples will be taken before and up to 3 hours after teast meal consumption

  • change in postprandial glucose concentrations after food intake

    1.5 week in total to cover both test days and 3-4 days prior to the test day

Study Arms (2)

Kori-tofu added to a carbohydrate rich meal

EXPERIMENTAL

Kori tofu as part of a carbohydrate rich meal

Other: Kori tofu

Whey protein added to a carbohydrate rich meal

ACTIVE COMPARATOR

Whey protein as part of a carbohydrate rich meal

Other: Whey protein

Interventions

Kori tofuOTHER

16.5 gram Kori-tofu mixed in a high carbohydrate test meal

Kori-tofu added to a carbohydrate rich meal
Whey proteinOTHER

high carbohydrate test meal with whey protein, matched in macronutrient content

Whey protein added to a carbohydrate rich meal

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>25 kg/m2
  • Having veins suitable for blood sampling via a catheter
  • Having one or more of the following criteria:
  • HbA1c\> 6%
  • fasting glucose \>6.1mmol/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 med-icines known to interfere with glucose homeostasis (judged by our study doctor)
  • 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.

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

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Diederik Esser, PhD

    Wageningen University and Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project leader clinical trials

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

January 6, 2020

Primary Completion

February 28, 2020

Study Completion

March 1, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)