NCT05177172

Brief Summary

In this project we will investigate synergistic effects of oat polar lipids and beta glucans on postprandial glucose tolerance

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2022

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

December 1, 2021

Last Update Submit

January 20, 2022

Conditions

Keywords

Preventionfooddiabetes type 2postprandial glucose regulationappetiteoatpolar lipidsobesityglucose tolerance

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance

    Postprandial glucose concentrations (mmol/L). The incremental area under the curve will be calculated and expressed as mmol\*minutes/litre.

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

Secondary Outcomes (1)

  • Subjective appetite variables

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

Study Arms (5)

Control

PLACEBO COMPARATOR

White wheat flour bread

Other: Control

High betaglucans

EXPERIMENTAL

White wheat flour bread included beta glucans with the highest amounts in this study

Other: High beta glucans

Low beta glucans

EXPERIMENTAL

White wheat flour bread included beta glucans with the lowest amounts in this study

Other: Low beta glucans

Low beta glucans + low polar lipids

EXPERIMENTAL

White wheat flour bread included a combination of the lowest amounts of beta glucans and polar lipids

Other: Low beta glucans + low polar lipids

low polar lipids

EXPERIMENTAL

White wheat flour bread included polar lipids

Other: Polar lipids

Interventions

higher dose betaglucans

High betaglucans

lower dose beta glucans

Low beta glucans

low dose betaglucans in a combination with low dose of polar lipids

Low beta glucans + low polar lipids

low dose polar lipids

low polar lipids
ControlOTHER

No beta glucans or polar lipids

Control

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • BMI 20-28 kg/m2
  • Diet which follows the Nordic Nutrition Recommendations (non-vegetarian)

You may not qualify if:

  • fasting glucose \> 6.1 mmol/L
  • metabolic diseases
  • gastrointestinal disease
  • chronic and/or psychological disease
  • food allergy
  • Vegetarian or vegan diets, or other special diets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University, Food Technology, Engineering and Nutrition

Lund, 22100, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Gyrate AtrophyObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesEye Diseases, HereditaryEye DiseasesChoroid DiseasesUveal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Four test products and one reference product (control). Participants are not aware of which product that is served at each visits
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomised food study in healthy subjects
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 1, 2021

First Posted

January 4, 2022

Study Start

December 1, 2021

Primary Completion

January 19, 2022

Study Completion

January 19, 2022

Last Updated

January 21, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Will be available after request

Locations