InflammationNCT03576703
Sugar-sweetened Beverages Influence Benefits of Exercise in Overweight Adults
A study testing Exercise with and without SSB ingestion in people with Inflammation and Insulin Sensitivity, run by Montana State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Insulin Sensitivity
- What is being tested?
- Exercise with and without SSB ingestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2014to 9 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 25 and < 35 kg/m2
- sedentary to moderately active
Who cannot join
- 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
About this study
Official title: The Influence of Diet During and After Exercise on Metabolic Benefits of Exercise in Overweight Adults
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.
Read the 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.
- Conditions
- Inflammation, Insulin Sensitivity
- Being tested
- Exercise with and without SSB ingestion
- Keywords
- metabolic syndrome, inflammation, insulin sensitivity, metabolic flexibility, overweight/obese
- Medical subject headings
- Inflammation, Insulin Resistance, Metabolic Syndrome, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with and without SSB ingestionOther
Consumption of a prescribed diet with and without SSB and performance of moderate aerobic exercise or resting/control
| Study group | Role | What they receive |
|---|---|---|
| EX+H2O | Experimental | Exercise and diet that did not include SSB Receives: Other: Exercise with and without SSB ingestion |
| EX+SSB | Experimental | Exercise and diet that includes SSB Receives: Other: Exercise with and without SSB ingestion |
| CONTROL | No intervention | No exercise and diet that did not include SSB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
75 g oral glucose tolerance test with measurement of glucose and insulin
Measured: 2 hours
Metabolic flexibility
Change in respiratory exchange ratio in response to ingestion of 75 g of glucose
Measured: 2 hours
Inflammation
Change in cytokine and reactive oxygen species concentrations after ingestion of 75 g of glucose
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start24 Oct 2014
- Primary completion9 Jul 2015
- Study completion9 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Miles, Montana State University
- Investigators
- Mary P Miles, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576703
- Sponsor's protocol ID
- MW CTR-IN 15-746Q-MSU-PG21-00
- Status last verified
- Jun 2018
- First submitted
- 26 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Diet During and After Exercise on Metabolic Benefits of Exercise in Overweight Adults
- ClinicalTrials.gov ID
- NCT03576703
- Acronym / sponsor ID
- MW CTR-IN 15-746Q-MSU-PG21-00
- Conditions
- Inflammation, Insulin Sensitivity
- Keywords
- metabolic syndrome, inflammation, insulin sensitivity, metabolic flexibility, overweight/obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- 24 Oct 2014 (actual)
- Primary completion
- 9 Jul 2015 (actual)
- Study completion
- 9 Jul 2015 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized crossover
| Arm | Type | Receives |
|---|---|---|
| EX+H2O | Experimental | Other: Exercise with and without SSB ingestionExercise and diet that did not include SSB |
| EX+SSB | Experimental | Other: Exercise with and without SSB ingestionExercise and diet that includes SSB |
| CONTROL | No intervention | –No exercise and diet that did not include SSB |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI > 25 and < 35 kg/m2
- sedentary to moderately active
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with and without SSB ingestionConsumption of a prescribed diet with and without SSB and performance of moderate aerobic exercise or resting/control | Other | EX+H2O, EX+SSB |
Primary outcome
Glucose tolerance
Time frame: 2 hours
75 g oral glucose tolerance test with measurement of glucose and insulin
Metabolic flexibility
Time frame: 2 hours
Change in respiratory exchange ratio in response to ingestion of 75 g of glucose
Inflammation
Time frame: 2 hours
Change in cytokine and reactive oxygen species concentrations after ingestion of 75 g of glucose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary P Miles, PhD principal investigator
Montana State University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with and without SSB ingestion in people with Inflammation and Insulin Sensitivity, run by Montana State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose tolerance (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.