NCT05824195

Brief Summary

The overall goal is to increase the knowledge that can be used for the development of food products with antidiabetic properties, with the aim of facilitating healthier food choices for people. More specifically, the primary aim of this project is to evaluate the effects of different varieties of quinoa on postprandial glucose tolerance and subjective appetite markers. The crossover, randomised dietary intervention study will be conducted in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

April 6, 2023

Last Update Submit

June 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance

    Capillary blood glucose concentrations are measured repeatedly after test products consumed at breakfast. The postprandial incremental glucose area under the curve is used as a measure of glucose tolerance.

    3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes

Secondary Outcomes (2)

  • serum insulin

    3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes

  • Subjective appetite sensations (hunger, satiety, and desire to eat)

    3 hours. Fasting (time =0 minutes), 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes

Study Arms (4)

Quinoa1

EXPERIMENTAL

Quinoa bread type1.

Other: Bread products

Quinoa 2

EXPERIMENTAL

Quinoa bread type 2

Other: Bread products

Quinoa 3

EXPERIMENTAL

Quinoa bread type 3

Other: Bread products

Reference

SHAM COMPARATOR

A white wheat bread

Other: Bread products

Interventions

Four intervention products were included in the study. Three experimental breads (quinoa 1, quinoa 2, quinoa 3) were developed, and consisted of white wheat breads substituted with the differrent quinoa types. The reference product included was a white wheat bread without quinoa. All intervention products contain 50 g available starch.

Quinoa 2Quinoa 3Quinoa1Reference

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI of 20-28
  • age between 18-40 years
  • Healthy
  • consume a diet in accordance with Nordic Nutrition Recommendations

You may not qualify if:

  • not vegan
  • metabolic diseases (such as diabetes)
  • Gastro intestine tract problems or irritable bowel syndrome
  • known food allergies of intolerances
  • smoker
  • antibiotics should not have been consumed during the last 4 weeks
  • probiotics should not have been consumed during the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University, dep of Food Technology, Engineering, and Nutrition

Lund, Välj..., 22100, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 21, 2023

Study Start

April 15, 2023

Primary Completion

June 3, 2023

Study Completion

June 3, 2023

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations