NCT04335565

Brief Summary

This study aims to assess the effect of stevia extract on postprandial glucose and insulin levels in overweight and obese adults when compared to sugar and water.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

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 3, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

May 10, 2021

Status Verified

April 1, 2020

Enrollment Period

12 months

First QC Date

April 2, 2020

Last Update Submit

May 7, 2021

Conditions

Keywords

Non-nutritive sweetenerspostprandial glucosediabetesobesitysatiety

Outcome Measures

Primary Outcomes (1)

  • Postprandial glucose levels

    Change in glucose levels two hours after the administration of a fixed meal

    Capillary blood glucose will be measured two hours after the administration of a fixed meal.

Secondary Outcomes (3)

  • Postprandial insulin levels

    Postprandial insulin levels will be measured two hours of the administration of a fixed meal

  • Area under the curve (AUC) for glucose

    Capillary blood glucose levels will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch

  • Subjective feelings of satiety

    VAS will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch.

Study Arms (3)

Water

NO INTERVENTION

250 ml of water mixed with 1g of citric acid.

Sugar

ACTIVE COMPARATOR

65g of sugar dissolved in 250ml of water

Other: sugar replacements

Stevia

EXPERIMENTAL

5g of stevia dissolved in 250ml of water

Other: sugar replacements

Interventions

Participants will receive a solution of stevia before being administered a fixed meal (lunch). Glucose and insulin levels, and Visual analogue scale data will be collected.

SteviaSugar

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years
  • BMI 27-40 Kg/m2
  • Males and females

You may not qualify if:

  • Athletes
  • Pregnant or breastfeeding women
  • Patients with chronic disease (diabetes, CVD etc…).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health sciences, Liverpool Hope University

Liverpool, L16 9JD, United Kingdom

Location

Related Publications (1)

  • Farhat G, Berset V, Moore L. Effects of Stevia Extract on Postprandial Glucose Response, Satiety and Energy Intake: A Three-Arm Crossover Trial. Nutrients. 2019 Dec 12;11(12):3036. doi: 10.3390/nu11123036.

    PMID: 31842388BACKGROUND

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Farzad Amirabdollahian, PhD

    Liverpool Hope University

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (participant)
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 6, 2020

Study Start

March 3, 2020

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

May 10, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations