NCT04499287

Brief Summary

This randomized crossover trial will investigate the metabolic responses following the consumption of a bagel+juice meal under 3 conditions: control, fiber (positive control), and postmeal walk in15 healthy adults. It is hypothesized that the postmeal walk will reduce glycemia, insulinemia, and oxidative stress similar to fiber.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 17, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2015

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2015

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 31, 2020

Last Update Submit

July 19, 2021

Conditions

Keywords

blood glucoseblood insulinfiberprediabetespostprandial glycemia

Outcome Measures

Primary Outcomes (2)

  • Postprandial glycemia

    incremental area under curve

    4 hours

  • postprandial insulinemia

    incremental area under curve

    4 hours

Secondary Outcomes (3)

  • postprandial oxidative stress

    4 hours

  • postprandial oxidative stress

    4 hours

  • postprandial oxidative stress

    4 hours

Study Arms (3)

Control

PLACEBO COMPARATOR

Test meal \[bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)\] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. Participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption. One week later the test meal was consumed with fiber (36 g, Metamucil powder, Procter\&Gamble, Cincinnati, OH) added to the apple juice (active) and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption . One week later participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes (experimental). Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption

Other: 15-minute walk at preferred walking speed.Dietary Supplement: FiberOther: control

Fiber

ACTIVE COMPARATOR

Test meal \[bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)\] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. 9 grams of soluble viscous fiber from psyllium husk (36 g, Metamucil powder, Procter\&Gamble, Cincinnati, OH) was mixed with the apple juice. Participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption. One week later participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes (experimental). Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption. One week later the test meal was consumed, and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (placebo).

Other: 15-minute walk at preferred walking speed.Dietary Supplement: FiberOther: control

Walk

EXPERIMENTAL

Test meal \[bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)\] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. Participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes. Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption One week later the test meal was consumed, and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (placebo comparator). One week later the test meal was consumed with fiber (36 g, Metamucil powder, Procter\&Gamble, Cincinnati, OH) added to the apple juice and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (active comparator).

Other: 15-minute walk at preferred walking speed.Dietary Supplement: FiberOther: control

Interventions

FiberDIETARY_SUPPLEMENT

9 grams soluble fiber

ControlFiberWalk
controlOTHER

control

ControlFiberWalk

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obese (BMI ≥ 30 kg/m2)
  • nonsmoking
  • sedentary
  • fasting capillary blood glucose that measured from 5.6 to 6.9 mmol/L

You may not qualify if:

  • answered "yes" to any of the questions on the "Par-Q \& You" questionnaire
  • refused to discontinue antioxidant supplement use for several weeks prior to and during the study
  • prescribed medication use (unless use was consistent for the 3 months prior to the study and intake remained consistent throughout the study duration)
  • food allergies or medical conditions that impacted normal functioning of the gastrointestinal tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prediabetic StateHyperglycemia

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: randomized, controlled, crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Associate Dean

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 5, 2020

Study Start

September 17, 2014

Primary Completion

February 14, 2015

Study Completion

March 10, 2015

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share