Effects of Diet and Exercise on Circadian Glycemia

NCT03922685 | Completed

• 1 other identifier: HUM00110793
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

Specific aims of the study are:

1. 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. 2.to determine whether one hour of post-meal moderate intensity exercise (at 50% of maximal effort) will further reduce postprandial glycemia.

Conditions

Glucose Intolerance

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Postprandial glucose-dependent insulinotropic peptide (GIP) concentration

  Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials

• Postprandial beta-hydroxybutyrate concentration

  Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials

• Postprandial leptin concentration

  Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials

Study Arms (4)

Morning sedentary arm

ACTIVE COMPARATOR

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)

Morning exercise arm

ACTIVE COMPARATOR

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)

Evening sedentary arm

ACTIVE COMPARATOR

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)

Evening exercise arm

ACTIVE COMPARATOR

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)

Interventions

Dietary manipulation (25% carbohydrate diet) and behavioral (exercise) COMBINATION_PRODUCT

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

Evening exercise arm; Morning exercise arm

Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary) COMBINATION_PRODUCT

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.

Evening sedentary arm; Morning sedentary arm

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• metabolic disease other than hormonally-corrected hypothyroidism
• musculo-skeletal disability that would preclude exercise
• smoker

Sponsors & Collaborators

• University of Michigan: lead
• Northern Michigan University: collaborator

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Katarina T Borer, Ph.D.

  Professor Emerita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: September 1, 2016
• Primary Completion: August 31, 2017
• Study Completion: April 1, 2019
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share