NCT04910828

Brief Summary

The aim of this study is to test high and low glycemic index foods in healthy adult volunteers and determine the effects on post meal pulse and blood pressure. Foods will be consumed before 8am after an overnight fast (10-12 hours) over a 10-15 minute period. Pulse and BP (where equipment is available) measurements will be taken 6 times at 5 min intervals before eating, and twice every 15 min thereafter for the following 2h. We will recruit between 30 to 40 students and 10 to 20 older adults to assess the effect of age, in cohorts of 10.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

May 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

May 27, 2021

Last Update Submit

May 27, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Heart Rate (pulse)

    Heart Rate (pulse)

    2 hours following consumption of food

  • Blood pressure

    Blood pressure

    2 hours following consumption of food

Study Arms (1)

Common foods of varying glycemic indices

EXPERIMENTAL

Common foods of varying glycemic indices

Other: Common foods of varying glycemic indices

Interventions

Examples of foods of varying glycemic index to be tested include bread, rice, breakfast cereals, starchy vegetables, legumes, fruit and dairy products.

Common foods of varying glycemic indices

Eligibility Criteria

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

You may qualify if:

  • Healthy adult volunteers

You may not qualify if:

  • Serious health condition preventing participants from eating 50g of "available" carbohydrates as a test breakfast. For example: 1) food intolerances or allergies to common foods; 2) gastrointestinal conditions requiring medical treatment (Crohn's, ulcerative colitis) and a special diet; 3) bariatric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

David Jenkins, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 2, 2021

Study Start

June 1, 2021

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05