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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Effects of Diet and Exercise on Circadian Glycemia

Clinicaltrials.gov identifier NCT03922685

Recruitment Status Completed

First Posted April 22, 2019

Last update posted April 22, 2019

Study Description

Brief summary:

Specific aims of the study are: 1. to evaluate whether a 24-h exposure to a 25%-carbohydrate diet will reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h),. and 2. to determine whether one hour of post-meal moderate intensity exercise (at 50% of maximal effort) will further reduce postprandial glycemia. The outcome measures are: plasma concentrations of glucose, insulin, glucose-dependent-insulinotropic peptide (GIP), leptin, and the ketone body beta-hydroxybutyrate.

  • Condition or Disease:Glucose Intolerance
  • Intervention/Treatment: Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (exercise)
    Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)
  • Phase: N/A
Detailed Description

The two hypotheses in this study are: 1. A 24-h exposure to a 25%-carbohydrate diet will reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h), and 2. One hour of moderate-intensity exercise (at 50% of maximal effort) will further reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h). Eight postmenopausal subjects (age 58.5 years, BMI 25.6 kg/m2) participated in 4 24-h long crossover trials, two terminating at 7h and the other 2 at 19h. At each circadian time one trial required 60 minutes of moderate-intensity exercise (50% of maximal effort), and the other two involved no exercise. Three 25%-carbohydrate meals prepared by the Michigan Clinical Research Unit (MCRU) kitchen, were eaten at subjects' home, and the fourth was eaten 20 minutes after subjects' arrival at MCRU at either 19 h or 7 h. Blood was collected from antecubital catheter at 10-minute intervals until 23:20 h or 11:20 h, respectively.Plasma was treated with protease inhibitor to preserve GIP, frozen at -80o C until glucose measurements by glucose oxidase, hormone measurements by chemiluminescence, and ketone measurements by Abbott meter strips. Exercise intensity was determined before the exercise trials on a treadmill from oxygen consumption (VO2) and carbon dioxide production (VCO2) by subjects walking on a treadmill at 3 mph with the treadmill slope increased by 2% every 3 minutes. Maximal effort was established when respiratory exchange ratio (VCO2/VO2) reached or exceeded 1. The treadmill speed and slope at half maximal effort was used during the one-hour exercise bout which was initiated 40 minutes after the start of the meal.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 8 participants
  • Allocation: Non-Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: The same eight subjects participated in counterbalanced order in: (1) sedentary morning trial, (2) exercise morning trial, (3) sedentary evening trial, (4) exercise evening trial.
  • Masking: None (Open Label) ()
  • Primary Purpose: Basic Science
  • Official Title: Control of Postprandial Glycemia: the Roles of Diet and Exercise
  • Actual Study Start Date: September 2016
  • Actual Primary Completion Date: August 2017
  • Actual Study Completion Date: April 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: Evening exercise arm
After arriving at MCRU at 19 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 19:20 h. At 8 h, subjects walked on the treadmill at 50% maximal effort. Between 19:20 and 23:20, 3-ml blood samples were collected at 10-min intervals.After the 23:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.
Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (exercise)
The 25% carbohydrate diet consisted of Pulmocare-vanilla liquid, white roll, butter, and string cheese in proportions to achieve 33% of weigh-maintenance diet containing 25% carbohydrate, 20% protein, and 55% fat. Exercise was walking 1 hour on level treadmill at 50% of maximal effort starting 40 minutes after the beginning of the meal
Active Comparator: Morning exercise arm
After arriving at MCRU at 7 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 7:20 h. At 8 h, subjects walked on the treadmill at 50% maximal effort. Between 7:20 and 11:20, 3-ml blood samples were collected at 10-min intervals.After the 11:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.
Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (exercise)
The 25% carbohydrate diet consisted of Pulmocare-vanilla liquid, white roll, butter, and string cheese in proportions to achieve 33% of weigh-maintenance diet containing 25% carbohydrate, 20% protein, and 55% fat. Exercise was walking 1 hour on level treadmill at 50% of maximal effort starting 40 minutes after the beginning of the meal
Active Comparator: Evening sedentary arm
After arriving at MCRU at 19 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 19:20 h. Over the next 4 hours, subjects reclined on a bed and had 3-ml blood samples collected at 10-min intervals. After the 23:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.
Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)
The 25% carbohydrate diet consisted of Pulmocare-vanilla liquid, white roll, butter, and string cheese in proportions to achieve 33% of weigh-maintenance diet containing 25% carbohydrate, 20% protein, and 55% fat. There was no exercise during this trial.
Active Comparator: Morning sedentary arm
After arriving at MCRU at 7 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 7:20 h. Over the next 4 hours, subjects reclined on a bed and had 3-ml blood samples collected at 10-min intervals. After the 11:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.
Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)
The 25% carbohydrate diet consisted of Pulmocare-vanilla liquid, white roll, butter, and string cheese in proportions to achieve 33% of weigh-maintenance diet containing 25% carbohydrate, 20% protein, and 55% fat. There was no exercise during this trial.
Outcome Measures
  • Primary Outcome Measures: 1. Postprandial glucose concentration [ Time Frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials ]
    The area under the postprandial glucose curve
  • 2. Postprandial insulin concentration [ Time Frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials ]
    The area under the postprandial insulin curve
  • Secondary Outcome Measures: 1. Postprandial glucose-dependent insulinotropic peptide (GIP) concentration [ Time Frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials ]
    The area under the postprandial GIP curve
  • 2. Postprandial beta-hydroxybutyrate concentration [ Time Frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials ]
    The area under the beta-hydroxybutyrate postprandial curve
  • 3. Postprandial leptin concentration [ Time Frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials ]
    The area under the leptin postprandial curve
Eligibility Criteria
  • Ages Eligible for Study: 50 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- postmenopausal

- normal blood glucose

- no cholesterol medication

- age between 50 an 65 years

- overweight but not obese

- BMI between 25 and 30 kg/m2

- weight-stable during past 6 months

- exercise less than 20 minutes three times a week

Exclusion Criteria:

- metabolic disease other than hormonally-corrected hypothyroidism

- musculo-skeletal disability that would preclude exercise

- smoker

- do not meet inclusion criteria

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

University of Michigan

Northern Michigan University

Investigators

Principal Investigator: Katarina T Borer, Ph.D. Professor Emerita

More Information
  • Responsible Party: University of Michigan
  • ClinicalTrials.gov Identifier: NCT03922685 History of Changes
  • Other Study ID Numbers: HUM00110793
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: April 22, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: There is no plan to share individual participant data with other researchers
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Glucose Intolerance