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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03576703
Other study ID # MW CTR-IN 15-746Q-MSU-PG21-00
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 24, 2014
Est. completion date July 9, 2015

Study information

Verified date June 2018
Source Montana State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date July 9, 2015
Est. primary completion date July 9, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Intervention

Other:
Exercise with and without SSB ingestion
Consumption of a prescribed diet with and without SSB and performance of moderate aerobic exercise or resting/control

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Montana State University

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose tolerance 75 g oral glucose tolerance test with measurement of glucose and insulin 2 hours
Primary Metabolic flexibility Change in respiratory exchange ratio in response to ingestion of 75 g of glucose 2 hours
Primary Inflammation Change in cytokine and reactive oxygen species concentrations after ingestion of 75 g of glucose 2 hours
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