NCT03722641

Brief Summary

The objective of this study is to investigate the effect on postprandial glycaemia in a healthy population after intake of milk and oat based products.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2018

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

October 4, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

October 24, 2018

Last Update Submit

July 2, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Postprandial glycaemia capillary

    Primary outcome is the difference in the two-hour incremental area under the curve (iAUC (0 - 120 min)) for capillary blood glucose between product 1-4 and the bread reference.

    0-120 min after consumption

Secondary Outcomes (18)

  • Postprandial glycaemia intravenous

    0-120 min

  • Postprandial Cmax capillary glucose

    0-180 min

  • Postprandial Cmax venous glucose

    0-180 min

  • Postprandial glycaemia capillary

    0-180 min

  • Postprandial glycaemia venous

    0-180 min

  • +13 more secondary outcomes

Study Arms (5)

Bread reference

PLACEBO COMPARATOR

A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.

Other: Bread referenceOther: Product 1: MilkOther: Product 2: Full fat milk + oatOther: Product 3: Skim milk + oat, high fibreOther: Product 4: Skim milk + oat, low fibre

Product 1: Milk

EXPERIMENTAL

A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.

Other: Bread referenceOther: Product 1: MilkOther: Product 2: Full fat milk + oatOther: Product 3: Skim milk + oat, high fibreOther: Product 4: Skim milk + oat, low fibre

Product 2: Full fat milk + oat

EXPERIMENTAL

A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on full fat milk and oat with high fiber content.

Other: Bread referenceOther: Product 1: MilkOther: Product 2: Full fat milk + oatOther: Product 3: Skim milk + oat, high fibreOther: Product 4: Skim milk + oat, low fibre

Product 3: Skim milk + oat, high fibre

EXPERIMENTAL

A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with high fiber content.

Other: Bread referenceOther: Product 1: MilkOther: Product 2: Full fat milk + oatOther: Product 3: Skim milk + oat, high fibreOther: Product 4: Skim milk + oat, low fibre

Product 4: Skim milk + oat, low fibre

EXPERIMENTAL

A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with low fiber content.

Other: Bread referenceOther: Product 1: MilkOther: Product 2: Full fat milk + oatOther: Product 3: Skim milk + oat, high fibreOther: Product 4: Skim milk + oat, low fibre

Interventions

Bread referenceOTHER

Commercially available white wheat bread

Bread referenceProduct 1: MilkProduct 2: Full fat milk + oatProduct 3: Skim milk + oat, high fibreProduct 4: Skim milk + oat, low fibre
Product 1: MilkOTHER

Developed reference product based on milk

Bread referenceProduct 1: MilkProduct 2: Full fat milk + oatProduct 3: Skim milk + oat, high fibreProduct 4: Skim milk + oat, low fibre
Product 2: Full fat milk + oatOTHER

Developed product based on full fat milk with addition of oat

Bread referenceProduct 1: MilkProduct 2: Full fat milk + oatProduct 3: Skim milk + oat, high fibreProduct 4: Skim milk + oat, low fibre
Product 3: Skim milk + oat, high fibreOTHER

Developed product based on skim milk with addition of oat giving a high fiber content to the product

Bread referenceProduct 1: MilkProduct 2: Full fat milk + oatProduct 3: Skim milk + oat, high fibreProduct 4: Skim milk + oat, low fibre
Product 4: Skim milk + oat, low fibreOTHER

Developed product based on skim milk with addition of oat giving a lower fiber content to the product

Bread referenceProduct 1: MilkProduct 2: Full fat milk + oatProduct 3: Skim milk + oat, high fibreProduct 4: Skim milk + oat, low fibre

Eligibility Criteria

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

You may qualify if:

  • Male or female 20 to 40 years of age
  • BMI 20-27 (±0.5) kg/m²
  • Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
  • Healthy as determined by medical history and information provided by the volunteer
  • Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
  • Has given voluntary, written, informed consent to participate in the study

You may not qualify if:

  • Elevated fasting blood glucose (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5)
  • Elevated fasting insulin (above 25 mIE/L)
  • Women who are pregnant or breast feeding
  • Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the SI
  • Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the SI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
  • Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
  • Use of antibiotics within 2 weeks of enrollment
  • Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
  • Allergy to ingredients included in investigational product, placebo or standardized meal
  • Participants restricted to a vegetarian or vegan diet
  • Intolerance to lactose or gluten
  • Individuals who are averse to venous catheterization or capillary blood sampling
  • Currently active smokers (or using other tobacco products, and e-cigarettes)
  • Unstable medical conditions as determined by SI
  • Participation in other clinical research trials
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aventure AB

Lund, Sweden

Location

MeSH Terms

Interventions

Ornithine-Oxo-Acid Transaminase

Intervention Hierarchy (Ancestors)

TransaminasesNitrogenous Group TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 29, 2018

Study Start

October 4, 2018

Primary Completion

March 5, 2019

Study Completion

March 5, 2019

Last Updated

July 5, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)