NCT04896619

Brief Summary

The study is a randomized, cross-over, double-blind, controlled trial in which participants with mildly elevated levels of cholesterol will receive two 4-week interventions (e.g. kori-tofu or control), with a wash-out period of 4 weeks in between. During the intervention periods, subjects will eat 3 slices of bread per day, representing a Kori-tofu dose of 34.5 grams or a matched reference. Fasting total and LDL cholesterol will be determined at the start and end of each of the two intervention periods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

May 10, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

May 10, 2021

Last Update Submit

December 8, 2021

Conditions

Lipid Metabolism Disorders

Keywords

Kori tofuCholesterol

Outcome Measures

Primary Outcomes (2)

  • Change in total cholesterol levels

    under fasting conditions

    0 weeks, 4 weeks, 8 weeks and 12 weeks

  • Change in LDL cholesterol levels

    under fasting conditions

    0 weeks, 4 weeks, 8 weeks and 12 weeks

Secondary Outcomes (10)

  • Change in HDL cholesterol levels

    0 weeks, 4 weeks, 8 weeks and 12 weeks

  • Change in triglycerides levels

    0 weeks, 4 weeks, 8 weeks and 12 weeks

  • Change in leptin levels

    0 weeks, 4 weeks, 8 weeks and 12 weeks

  • Change in adiponectin levels

    0 weeks, 4 weeks, 8 weeks and 12 weeks

  • Change in plasma insulin levels

    0 weeks, 4 weeks, 8 weeks and 12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Daily dose of Kori-tofu mixed in 3 slices of bread

EXPERIMENTAL

Kori tofu as part of bread

Other: Kori tofu bread

Daily dose of whey protein, soy oil and maltodextrin mixed in 3 slices of bread

ACTIVE COMPARATOR

Whey protein, soy oil and maltodextrin as part of bread

Other: Whey protein bread

Interventions

Kori tofu breadOTHER

34.5 grams of Kori-tofu, mixed in 3 slices of wheat bread.

Daily dose of Kori-tofu mixed in 3 slices of bread
Whey protein breadOTHER

Matched whey protein, soy oil and maltodextrin/cellulose, mixed in 3 slices of wheat bread

Daily dose of whey protein, soy oil and maltodextrin mixed in 3 slices of bread

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 40-70 years;
  • BMI between 18.5-35 kg/m2;
  • Total cholesterol levels \>5 mmol/L or LDL \>3 mmol/L

You may not qualify if:

  • Use of medication/supplements/food items that may influence the study results, such as cholesterol lowering medication, Becel ProActiv (judged by our research physician);
  • Total cholesterol levels \>7 mmol/L;
  • LDL cholesterol levels \>5 mmol/L;
  • 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;
  • Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported);
  • Abuse of soft and/or hard drugs;
  • Food allergies or intolerances for products that we use in the study;
  • Participation in another clinical trial at the same time; NL75320.081.20 CHOKO Version number: 4, April 2021 15 of 34
  • 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)

Wageningen University & Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Diederik Esser, PhD

    Wageningen University & Research

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 21, 2021

Study Start

September 7, 2021

Primary Completion

December 7, 2021

Study Completion

December 7, 2021

Last Updated

December 9, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)