Mealtime Walking Study to Improve Postprandial Metabolic Response

PreDiabetes Clinical Trial

Official title:

Mealtime Walking Study to Improve Postprandial Metabolic Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499287
• Other study ID #: OxPMW
• Status: Completed
• Phase: N/A
• Start date: September 17, 2014
• Est. completion date: March 10, 2015

Study information

• Verified date: July 2021
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will follow a randomized, crossover design. Participants and the investigator will be blinded for the control treatments but not for the walk treatment. Participants will complete 3 meal tests; tests are separated by about 1 week. An initial screening visit will be scheduled for the online survey respondents that meet the inclusion criteria and are willing to consider participation. At this visit, written consent will be secured followed by further screening for the exclusion criteria and the collection of demographic and health history data and anthropometric measures. A fasting blood sample will be collected for glucose analysis. Participants will be scheduled for experimental testing and provided with instructions and calendars. Participants will be given at least one week's notice if they do not qualify for the trial based on fasting glucose concentrations.

On the day prior to each experimental day, the participants will consume 2 bagels (54 g carbohydrate/bagel), and on the night prior to each visit, participants will consume a standard dinner of their choice. (The bagels will be provided to participants and the standardized dinner will be documented. The bagels and standardized dinner meal will facilitate controlled 'glycogen loading' prior to testing.) No other food will be consumed after this dinner meal, and participants will fast overnight until they arrive at the research center the next morning (e.g., no food or beverage with the exception of water). Fasting blood (1 tablespoon) will be collected and the test meal (bagel+juice) will be consumed. Postprandial blood samples will be collected for 4 hours (see below). The subjects will not be allowed to consume any food or beverage (with the exception of water) through the duration the visit. A snack will be provided to participants once the testing is over.

Glucose: 0,15,30,60,120, 180, 240 Insulin: 0, 30, 120, 180, 240 Oxidative Stress Markers: 0, 180, 240

The blood insulin level will be determined in venous blood by RIA. Capillary blood glucose will be determined with a glucometer. Oxidative stress, e.g., total antioxidant capacity, IL-6, and TBARS will be assessed using microplate analyses kits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 10, 2015
• Est. primary completion date: February 14, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• obese (BMI = 30 kg/m2)

• nonsmoking

• sedentary

• fasting capillary blood glucose that measured from 5.6 to 6.9 mmol/L

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• Hyperglycemia
• Postprandial Hyperglycemia
• PreDiabetes
• Prediabetic State

Intervention

Other:
• 15-minute walk at preferred walking speed.

Dietary Supplement:
• Fiber
9 grams soluble fiber

Other:
• control
control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemia	incremental area under curve	4 hours
Primary	postprandial insulinemia	incremental area under curve	4 hours
Secondary	postprandial oxidative stress	total antioxidant capacity of blood	4 hours
Secondary	postprandial oxidative stress	blood interleukin-6	4 hours
Secondary	postprandial oxidative stress	Thiobarbituric Acid Reactive Substances TBARS	4 hours