Brief Summary

Food manufacturers are being tasked to reduce the added sugar content of products. Rare, but natural sugars, may serve as useful sweeteners as they are low-calorie, safe, sweet and have a mild taste. Previous studies have shown that consuming rare sugars alongside other carbohydrates leads to a lower spike in blood glucose after eating. This means that products containing rare sugars may provide health benefits. However, most studies use rare sugars in a glucose drink, so the effect of consuming rare sugars in foods is not known. The aim of this study is to find out whether consuming sweet crème products containing rare sugars reduces the blood glucose response compared to sucrose-only products. The effect of the rare sugar products on hunger and appetite will also be assessed. Participants will attend the Clinical Research Facility on 6 occasions, after fasting for 10 hours. At each visit, they will consume a different sample of sweet crème. They will be asked to give blood samples before eating the sample, and at regular intervals for 2 hours afterwards. They will also complete questionnaires to assess their appetite using linear scales. Blood samples will be analysed in the laboratory to measure the level of glucose and insulin at each time point. The changes in blood glucose and insulin after consuming the different samples will be compared to find out if the samples containing rare sugars reduced the response.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach

1 country

2 active sites

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

6 months study duration

First Submitted

Initial submission to the registry

April 25, 2022

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed

2 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed

Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

April 25, 2022

Last Update Submit

April 25, 2022

Conditions

Glycaemic Response in Healthy Participants

Outcome Measures

Primary Outcomes (1)

Integrated area under the curve (iAUC) for plasma glucose.
Differences in the iAUC for plasma glucose after consuming each product.
120 minutes

Secondary Outcomes (7)

Peak plasma glucose
120 minutes
Integrated area under the curve (iAUC) for plasma insulin.
120 minutes.
Peak plasma insulin
120 minutes.
Integrated area under the curve (iAUC) and peak value for plasma GLP-1.
120 minutes.
Integrated area under the curve (iAUC) and peak value for plasma GIP.
120 minutes.
+2 more secondary outcomes

Study Arms (6)

Group T: ABCDEF

EXPERIMENTAL

Participants will receive all six blind-coded samples, in the order A, B, C, D, E, F. There will be a minimum of 7 days washout between samples.