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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03922685
Other study ID # HUM00110793
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date April 2019

Study information

Verified date April 2019
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date April 2019
Est. primary completion date August 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Northern Michigan University

Outcome

Type Measure Description Time frame Safety issue
Primary Postprandial glucose concentration The area under the postprandial glucose curve Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Primary Postprandial insulin concentration The area under the postprandial insulin curve Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Secondary Postprandial glucose-dependent insulinotropic peptide (GIP) concentration The area under the postprandial GIP curve Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Secondary Postprandial beta-hydroxybutyrate concentration The area under the beta-hydroxybutyrate postprandial curve Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Secondary Postprandial leptin concentration The area under the leptin postprandial curve Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
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