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Effects of Diet and Exercise on Circadian Glycemia

Control of Postprandial Glycemia: the Roles of Diet and Exercise

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03922685
Acronym
GLYCEMIA
Enrollment
8
Registered
2019-04-22
Start date
2016-09-01
Completion date
2019-04-30
Last updated
2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Intolerance

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.

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.

Interventions

COMBINATION_PRODUCTDietary 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_PRODUCTDietary 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.

Sponsors

Northern Michigan University
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postprandial glucose concentrationFour hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trialsThe area under the postprandial glucose curve
Postprandial insulin concentrationFour hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trialsThe area under the postprandial insulin curve

Secondary

MeasureTime frameDescription
Postprandial glucose-dependent insulinotropic peptide (GIP) concentrationFour hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trialsThe area under the postprandial GIP curve
Postprandial beta-hydroxybutyrate concentrationFour hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trialsThe area under the beta-hydroxybutyrate postprandial curve
Postprandial leptin concentrationFour hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trialsThe area under the leptin postprandial curve

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026