- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06949683
Effects of Meal and Exercise Sequence on Glucose and Blood Pressure Responses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Trial days In the 24 h prior to each main trial, participants were asked to refrain from performing any strenuous physical activity and from consuming alcohol/caffeine. Dinner intake was recorded before the first main trial and participants were asked to replicate this diet prior to their second main trial.
On main trial days, participants arrived at the laboratory between 8-9 am following a 10-hour fast. After measuring height, blood pressure, pulse, and obtaining finger-prick blood samples, participants underwent EM or ME intervention.
The entire experiment lasted a total of 150 minutes. During the initial 50 minutes, participants were randomly assigned to either exercise before or after breakfast. Participants were asked to finish their breakfast within approximately 5 minutes. The exercise regimen consisted of brisk walking for 22 minutes at a speed of 6 km/hr on the indoor track. After a 25-minute break, the second meal was provided. Participants then underwent a 75-minute observation period during the postprandial phase. Blood pressure and pulse were assessed with the individual seated in a relaxed, upright position on a chair, with the arm properly positioned. Two measurements of blood pressure and pulse were taken, and these values were averaged to ensure that the two readings were within 5 mmHg of each other. If the two readings differed by more than 5 mmHg, additional readings were taken until the outlying measurement was excluded. The test meal consists of red bean dorayaki (CHUAN LIAN Enterprise Co., Ltd.) and soy milk (I-MEI Foods Co., Ltd.). The breakfast provided contained 348 kcal, with a macronutrient distribution of 60% carbohydrates, 12% protein, and 28% fat. The second meal contained 207 kcal, with a macronutrient distribution of 66% carbohydrates, 6% protein, and 28% fat.
Finger-prick blood samples, blood pressure, and pulse were measured every 25 minutes during the experiment using the Freestyle Optium Neo (Abbott Diabetes Care, Ltd., UK) and the OMRON HEM-7320 blood pressure monitor (OMRON Co., Ltd., Japan). Two measurements of blood pressure and pulse were taken, and these values were averaged to ensure that the two readings were within 5 mmHg of each other. If the two readings differed by more than 5 mmHg, additional readings were taken until the outlying measurement was excluded. Blood pressure and pulse were assessed with the individual seated in a relaxed, upright position on a chair, with the arm properly positioned.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan
- National Taiwan Normal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 20 and 45 years
- Body Mass Index (BMI) ranging from 18.5 to 27 kg/m2
- No habits of heavy drinking or smoking, or have quit smoking for at least 6 months
- Absence of diabetes, cardiovascular, or metabolic-related disorders
- Not currently taking medications, or other supplements that may affect blood sugar, blood pressure, or metabolic changes
- No current sports injuries or medical advice against exercise
- No significant weight fluctuations in the past three months (within ±3% of usual body weight)
- Not experiencing shift work or travel across time zones within the past 6 months
- No current plans to change lifestyle habits and willing to adhere to the requirements of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Meal-Exercise
Breakfast intake before 22 minutes of brisk walking
|
Breakfast intake before 22 minutes of brisk walking, followed by a lunch intake for another 75 minutes of observation period.
The entire experiment lasted a total of 150 minutes.
|
|
Experimental: Exercise-Meal
22 minutes of brisk walking before breakfast intake
|
22 minutes of brisk walking before breakfast intake, followed by 75 minutes of observational period.
The entire experiment lasted a total of 150 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial glucose concentrations
Time Frame: 150 minutes
|
Changes in glucose responses during trials
|
150 minutes
|
|
Blood pressure
Time Frame: 150 minutes
|
Changes in blood pressure (e.g., diastolic and systolic blood pressure) during trials
|
150 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202310HM014-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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