Trials / Completed
CompletedNCT03922685
Effects of Diet and Exercise on Circadian Glycemia
Control of Postprandial Glycemia: the Roles of Diet and Exercise
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- Female
- Age
- 50 Years – 65 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| 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. |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-08-31
- Completion
- 2019-04-01
- First posted
- 2019-04-22
- Last updated
- 2019-04-22
Source: ClinicalTrials.gov record NCT03922685. Inclusion in this directory is not an endorsement.