Exercise-meal Timing and Postprandial Glucose Control

NCT03730727 | Completed

• 1 other identifier: ERN_18-0942
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity helps maintain optimal postprandial blood glucose control. However, there is a lack of clear information regarding the optimal meal-activity timing required to maximize blood glucose control. By using continuous glucose monitoring (CGM), this randomized controlled trial will determine whether implementing a bout of physical activity immediately before, or immediately after, or shortly after a meal is most optimal. This study will also independently examine the effects of three different physical activities: walking, standing, and circuit-exercises. Minimizing the changes in blood glucose following a meal not only reduces the risk of type 2 diabetes but also reduces cardiovascular-related mortality. Therefore, the data produced by this project will have very important implications for informing healthcare policy and physical activity recommendations.

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia, Postprandial; Physical Activity; Glucose Intolerance

Keywords

Exercise; Type 2 diabetes; Walking; Standing; Circuit exercises; Inactivity; Blood glucose control; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Postprandial blood glucose concentrations.

  Continuous glucose monitoring (CGM; Dexcom G5 Mobile) will be used to measure the change in glucose levels from baseline.

  In all trials, postprandial blood glucose concentrations will be measured - the change from baseline (immediately prior to meal ingestion) 2-hours after meal ingestion.

Secondary Outcomes (3)

• Postprandial blood glucose control (mean).

  In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).

• Postprandial blood glucose control (standard deviation).

  In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).

• Postprandial blood glucose control.

  In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).

Study Arms (4)

Control

ACTIVE COMPARATOR

A liquid meal replacement shake containing 500 kcal (55% kcals from carb, 30% fat, 15% protein) will be administered at approx. 8 am following an 8-10 hour overnight fast. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. Two-hours after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises \[10 squats, 10 push-ups, 10 lunges, 10 sit-ups\]).

Behavioral: Physical activity; Dietary Supplement: Meal

Immediate prior to meal

EXPERIMENTAL

At approx. 8 am following an 8-10 hour overnight fast, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises \[10 squats, 10 push-ups, 10 lunges, 10 sit-ups\]). Immediately after completion of this bout, a liquid meal replacement shake containing 500 kcal will be administered. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion.

Behavioral: Physical activity; Dietary Supplement: Meal

Immediate post-meal

EXPERIMENTAL

A liquid meal replacement shake containing 500 kcal will be administered at approx. 8 am following an 8-10 hour overnight fast. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. Immediately after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises \[10 squats, 10 push-ups, 10 lunges, 10 sit-ups\]).

Behavioral: Physical activity; Dietary Supplement: Meal

30-minutes post-meal

EXPERIMENTAL

A liquid meal replacement shake containing 500 kcal will be administered at approx. 8 am following an 8-10 hour overnight fast. Postprandial blood glucose responses will be assessed for 2-hours post-ingestion. Thirty-minutes after ingestion of the meal, participants will complete a bout of physical activity (either 30-mins of standing still, 30-mins of walking at a self selected brisk pace on a treadmill, or 3-sets of circuit-exercises \[10 squats, 10 push-ups, 10 lunges, 10 sit-ups\]).

Behavioral: Physical activity; Dietary Supplement: Meal

Interventions

Physical activity BEHAVIORAL

Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).

30-minutes post-meal; Control; Immediate post-meal; Immediate prior to meal

Meal DIETARY_SUPPLEMENT

Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.

30-minutes post-meal; Control; Immediate post-meal; Immediate prior to meal

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years.
• Body Mass Index 18-30 kg/m2.
• Generally healthy.

You may not qualify if:

• Smoking.
• Pregnancy, or planning to become pregnant, or a nursing mother.
• More than 2 kg weight change during the last month.
• Diabetes.
• Evidence of, or being treated for, cancer or infectious/non-infectious chronic hematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal diseases.
• Any contraindication to exercise

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

University of Birmingham

Edgbaston, West Midlands, B15 2TT, United Kingdom

Location

Related Publications (1)

• Solomon TPJ, Tarry E, Hudson CO, Fitt AI, Laye MJ. Immediate post-breakfast physical activity improves interstitial postprandial glycemia: a comparison of different activity-meal timings. Pflugers Arch. 2020 Feb;472(2):271-280. doi: 10.1007/s00424-019-02300-4. Epub 2019 Aug 8.

  PMID: 31396757 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Motor Activity; Glucose Intolerance; Sedentary Behavior

Interventions

Exercise; Meals

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Although the trial order will be randomized, it is not possible to blind the participant or the investigator to the timing between meals and physical activity. However, the trial allocation and order will be blinded to the outcomes assessor when statistical analyses are performed.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three independent groups of participants will enter 1 of 3 studies, each of which involves a randomised, crossover, controlled trial containing 4 trials: (i) control, meal ingestion no activity; (ii) activity bout immediately prior to meal; (iii) activity bout immediately after ingestion of meal; (iv) activity bout 30-mins after ingestion of meal.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 5, 2018
• Study Start: October 9, 2017
• Primary Completion: November 9, 2018
• Study Completion: December 8, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

GB (1)