NCT03923205

Brief Summary

Buckwheat is a unique crop because is naturally rich in compounds that have shown beneficial effects on glucose metabolism. A constant high glucose level in blood after meal consumption is an independent risk factor for cardiovascular complications and death. In order to prevent Type 2 Diabetes Mellitus (T2D) and/or its complications it is important to have a strict control of the blood glucose levels after a meal. There are known therapies for the control of the high glucose blood levels such as agents that act on intestinal digestion of carbohydrates and therapeutic agents that mimic the insulin response after a meal. The combination of these type of agents was commonly prescribed in the treatment of T2D. The aim of the study is to assess the effect of a buckwheat beverage on postprandial glucose metabolism in healthy individuals and those with T2D controlled by medication and diet.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

March 7, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

April 3, 2019

Last Update Submit

April 17, 2019

Conditions

HealthyType2 Diabetes

Keywords

buckwheatpostprandial glycemiaType 2 diabetes

Outcome Measures

Primary Outcomes (2)

  • post prandial blood glucose (recording cmax)

    Postprandial blood glucose levels after acute consumption of a buckwheat beverage, recording the maximum blood glucose concentration (c max) over the baseline after the consumption of a buckwheat beverage.

    five hours

  • AUC for postprandial glucose

    Area under the curve described by the postprandial glucose level during five hours time

    five hours

Secondary Outcomes (4)

  • post prandial blood insulin in blood ( including AUC)

    five hours

  • Buckwheat beverage key bioactives bioavailability and metabolism.

    five hours

  • Urine ratio of myo and D-chiro inositol

    0, 3 and 5 hours

  • Urine glucose concentration

    0, 3 and 5 hours

Study Arms (2)

Control meal

ACTIVE COMPARATOR

The control meal will be a standard OGT test containing 75 g glucose dissolved in 300 mL of water followed by 100 mL water.

Other: Dietary Intervention

The test meal

ACTIVE COMPARATOR

The test meal contains 100 g of the buckwheat beverage and 75 g glucose dissolved in 300 mL water followed by 100 mL water.

Other: Dietary Intervention

Interventions

Dietary InterventionOTHER

The effect of a buckwheat beverage on postprandial glucose metabolism in healthy individuals and those with T2D controlled by medication and diet will be studied.

Control mealThe test meal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy and T2D (controlled by diet and lifestyle or metformin) volunteers; Age 18+; males and females.

You may not qualify if:

  • For the healthy group:
  • taking prescribed medication
  • HbA1c above 48mmol/mol (or 6.5%)
  • pregnant or breastfeeding
  • blood donation in the last three months
  • unable to give written informed consent
  • eating disorders such as anorexia, bulimia, binge eating or night eating syndrome.
  • significant health issue
  • taking vitamin or mineral supplements (unless they agree to discontinue supplementation 2 weeks or more before the start of the study)
  • Food allergies/intolerances
  • For the T2D groups:
  • T2D controlled by medication other than metformin
  • pregnant or breastfeeding
  • blood donation in the last three months
  • unable to give written informed consent
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowett Institute, University of Aberdeen

Aberdeen, AB 25 2ZD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Three groups ; healthy volunteers, individuals with T2D controlled by medication and individuals with T2D controlled by diet and lifestyle only. All groups follow same interventions assigned randomly.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 22, 2019

Study Start

March 7, 2019

Primary Completion

September 7, 2020

Study Completion

March 31, 2021

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)