PreDiabetesNCT04499287
Mealtime Walking Study to Improve Postprandial Metabolic Response
A study testing 15-minute walk at preferred walking speed. and Fiber in people with PreDiabetes and Postprandial Hyperglycemia, run by Arizona State University.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Postprandial Hyperglycemia
- What is being tested?
- 15-minute walk at preferred walking speed. and Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2014to 10 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- obese (BMI ≥ 30 kg/m2)
- nonsmoking
- sedentary
- fasting capillary blood glucose that measured from 5.6 to 6.9 mmol/L
Who cannot join
- 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
About this study
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.
Read the detailed 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.
- Conditions
- PreDiabetes, Postprandial Hyperglycemia
- Being tested
- 15-minute walk at preferred walking speed., Fiber, control
- Keywords
- blood glucose, blood insulin, fiber, prediabetes, postprandial glycemia
- Medical subject headings
- Prediabetic State, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15-minute walk at preferred walking speed.Other
FiberDietary supplement
9 grams soluble fiber
controlOther
control
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: 15-minute walk at preferred walking speed.; Dietary Supplement: Fiber; Other: 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). Receives: Other: 15-minute walk at preferred walking speed.; Dietary Supplement: Fiber; Other: 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). Receives: Other: 15-minute walk at preferred walking speed.; Dietary Supplement: Fiber; Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemia
incremental area under curve
Measured: 4 hours
postprandial insulinemia
incremental area under curve
Measured: 4 hours
Secondary outcomes (3)
postprandial oxidative stress
total antioxidant capacity of blood
Measured: 4 hours
postprandial oxidative stress
blood interleukin-6
Measured: 4 hours
postprandial oxidative stress
Thiobarbituric Acid Reactive Substances TBARS
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start17 Sep 2014
- Primary completion14 Feb 2015
- Study completion10 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, controlled, crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Johnston, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499287
- Sponsor's protocol ID
- OxPMW
- Status last verified
- Jul 2021
- First submitted
- 31 Jul 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mealtime Walking Study to Improve Postprandial Metabolic Response
- ClinicalTrials.gov ID
- NCT04499287
- Acronym / sponsor ID
- OxPMW
- Conditions
- PreDiabetes, Postprandial Hyperglycemia
- Keywords
- blood glucose, blood insulin, fiber, prediabetes, postprandial glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 17 Sep 2014 (actual)
- Primary completion
- 14 Feb 2015 (actual)
- Study completion
- 10 Mar 2015 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized, controlled, crossover
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: 15-minute walk at preferred walking speed., Dietary Supplement: Fiber, Other: controlTest 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 |
| Fiber | Active comparator | Other: 15-minute walk at preferred walking speed., Dietary Supplement: Fiber, Other: controlTest 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). |
| Walk | Experimental | Other: 15-minute walk at preferred walking speed., Dietary Supplement: Fiber, Other: controlTest 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). |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- obese (BMI ≥ 30 kg/m2)
- nonsmoking
- sedentary
- fasting capillary blood glucose that measured from 5.6 to 6.9 mmol/L
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15-minute walk at preferred walking speed. | Other | Control, Fiber, Walk |
| Fiber9 grams soluble fiber | Dietary supplement | Control, Fiber, Walk |
| controlcontrol | Other | Control, Fiber, Walk |
Primary outcome
Postprandial glycemia
Time frame: 4 hours
incremental area under curve
postprandial insulinemia
Time frame: 4 hours
incremental area under curve
3 secondary outcomes
postprandial oxidative stress
Time frame: 4 hours
postprandial oxidative stress
Time frame: 4 hours
postprandial oxidative stress
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for PreDiabetes
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Active, not recruitingEarly Phase 1
Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Prostate Cancer
Not yet recruitingPhase 4
Effect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance
MAFLD in Prediabetes and Diabetes
Not yet recruiting
Trial of CGM Technology in Persons Living With Prediabetes
Prediabetes
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 15-minute walk at preferred walking speed. and Fiber in people with PreDiabetes and Postprandial Hyperglycemia, run by Arizona State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glycemia (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.