Sugar-sweetened Beverages Influence Benefits of Exercise in Overweight Adults
Primary Purpose
Inflammation, Insulin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise with and without SSB ingestion
Sponsored by
About this trial
This is an interventional prevention trial for Inflammation focused on measuring metabolic syndrome, inflammation, insulin sensitivity, metabolic flexibility, overweight/obese
Eligibility Criteria
Inclusion Criteria:
- BMI > 25 and < 35 kg/m2
- sedentary to moderately active
Exclusion Criteria:
- inflammatory conditions
- heart disease, diabetes, and other diseases that may interfere with the safety of exercise or other experimental procedures
- allergy to wheat, gluten, dairy, or peanuts
- taking blood pressure, cholesterol lowering, or anti-inflammatory medications
- taking hormone-based birth control with exception of intrauterine device,
- pregnant
- health concerns that make it difficult to participate in study procedures
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
EX+H2O
EX+SSB
CONTROL
Arm Description
Exercise and diet that did not include SSB
Exercise and diet that includes SSB
No exercise and diet that did not include SSB
Outcomes
Primary Outcome Measures
Glucose tolerance
75 g oral glucose tolerance test with measurement of glucose and insulin
Metabolic flexibility
Change in respiratory exchange ratio in response to ingestion of 75 g of glucose
Inflammation
Change in cytokine and reactive oxygen species concentrations after ingestion of 75 g of glucose
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03576703
Brief Title
Sugar-sweetened Beverages Influence Benefits of Exercise in Overweight Adults
Official Title
The Influence of Diet During and After Exercise on Metabolic Benefits of Exercise in Overweight Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 24, 2014 (Actual)
Primary Completion Date
July 9, 2015 (Actual)
Study Completion Date
July 9, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montana State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to determine how metabolic and inflammatory effects of physical exercise in overweight individuals are altered when sugar-sweetened beverages (SSB) are consumed after physical exercise. A randomized, controlled crossover trial was performed in which participants performed exercise with and without the ingestions of SSB during exercise or a non-exercise control condition to evaluate metabolic and inflammatory responses one day after the exercise and or SSB treatment.
Detailed Description
Participants: Women (n=24; 18-55 y) with a BMI > 25 and < 35 kg·m-2 who are sedentary to moderately active were recruited to participate. Research Design: This study was a randomized, counter-balanced, cross-over clinical trial consisting of three experimental conditions in which each participant served as her/his own control. Assessments of health history, physical activity (to confirm that participants were physically inactive), anthropometrics, resting metabolic rate, and aerobic capacity were made during an initial laboratory visit. Participants performed three different study conditions, typically separated by one week, thus women were not tested in a specific menstrual cycle phase. Participants recorded their diet the day before and the morning of the first condition and replicated this for the second and third conditions. On the study days, participants consumed their breakfast prior to 9:00 AM and arrived in the lab at 11 AM. The three conditions were performed in randomized order. In the control condition (CON), participants rested quietly for 1 hour. In the remaining two conditions, participants performed 45 minutes of treadmill exercise at 11 AM. Following the rest or exercise period, subjects were provided energy balanced diets. Total energy intake was balanced across exercise conditions and appropriately adjusted for the lack of exercise in the CON condition. At 7 AM on the following morning, following an overnight fast, an oral glucose tolerance test (OGTT) was performed. Measurements were made to determine fasting glucose, insulin and lipid panel, 2-hour OGTT glucose, insulin sensitivity (SI OGTT), early (0-30 min) and late (30-120 min) glucose stimulated insulin secretion (GSIS) based on c-peptide concentrations. Indirect calorimetry was also performed to determine resting carbohydrate and fat oxidation and metabolic flexibility, defined as the change in respiratory exchange ration (RER) during the OGTT. Interleukin-6, tumor necrosis factor-alpha, and reactive oxygen species were measure before, 60, and 120 minutes during the OGTT to assess the inflammation response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Insulin Sensitivity
Keywords
metabolic syndrome, inflammation, insulin sensitivity, metabolic flexibility, overweight/obese
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized crossover
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EX+H2O
Arm Type
Experimental
Arm Description
Exercise and diet that did not include SSB
Arm Title
EX+SSB
Arm Type
Experimental
Arm Description
Exercise and diet that includes SSB
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
No exercise and diet that did not include SSB
Intervention Type
Other
Intervention Name(s)
Exercise with and without SSB ingestion
Intervention Description
Consumption of a prescribed diet with and without SSB and performance of moderate aerobic exercise or resting/control
Primary Outcome Measure Information:
Title
Glucose tolerance
Description
75 g oral glucose tolerance test with measurement of glucose and insulin
Time Frame
2 hours
Title
Metabolic flexibility
Description
Change in respiratory exchange ratio in response to ingestion of 75 g of glucose
Time Frame
2 hours
Title
Inflammation
Description
Change in cytokine and reactive oxygen species concentrations after ingestion of 75 g of glucose
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI > 25 and < 35 kg/m2
sedentary to moderately active
Exclusion Criteria:
inflammatory conditions
heart disease, diabetes, and other diseases that may interfere with the safety of exercise or other experimental procedures
allergy to wheat, gluten, dairy, or peanuts
taking blood pressure, cholesterol lowering, or anti-inflammatory medications
taking hormone-based birth control with exception of intrauterine device,
pregnant
health concerns that make it difficult to participate in study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary P Miles, PhD
Organizational Affiliation
Montana State University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Sugar-sweetened Beverages Influence Benefits of Exercise in Overweight Adults
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