Brief Summary

The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline

Completed

Started Nov 2014

Shorter than P25 for not_applicable type-2-diabetes-mellitus

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

11 months study duration

Study Start

First participant enrolled

November 1, 2014

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed

8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed

Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

November 5, 2014

Last Update Submit

May 2, 2018

Conditions

Type 2 Diabetes Mellitus

Keywords

Risk for Type 2 Diabetes MellitusFibrePostprandial GlucosePostprandial InsulinPostprandial AcetaminophenSatiety

Outcome Measures

Primary Outcomes (4)

Fasting and postprandial blood glucose response for each pudding and control product
Blood glucose will be measured in the fasting state and postprandially through finger prick blood samples at each study visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Blood glucose will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Fasting and postprandial insulin response for each pudding and control product
Insulin will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Blood insulin will be analyzed for each each study visit (10 in total), at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Fasting and postprandial acetaminophen absorption for each pudding and control product
Acetaminophen will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Blood acetaminophen will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Satiety-producing effect for each pudding and control product
Participants will complete visual analogue scale (VAS) questionnaires during each treatment visit to subjectively measure satiety. They will be asked to complete an initial VAS questionnaire when fasted, and will then consume one of 10 treatments within 10 minutes, and complete VAS questionnaires 5 minutes before each blood sample at times 10, 25, 55, 85, and 115 minutes. After 120 minutes have passed, participants will consume an ad libitum pizza lunch buffet meal to objectively measure satiety, and once comfortably full they will complete a final VAS questionnaire. Weighed food records will be used to objectively measure food intake for the rest of the day. This will occur once a week for 10 weeks until all treatments have been consumed.
Satiety will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.

Secondary Outcomes (1)

3-Day food records
Over 3 days before the first treatment study visit

Other Outcomes (2)

Fasted body weight
At each study treatment visit
Heart rate and blood pressure
At each study treatment visit