Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT05910489 - Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect