NCT05700292

Brief Summary

Background: Obesity is a multifactorial disease that affects 36% of the Mexican population; it is characterized by the excessive accumulation of adipose tissue in the body, mainly in the abdominal region, conditions that are closely linked to low-grade systemic inflammation (LGSI). Scientific evidence suggests that LGSI can be attenuated by the benefits of regular physical exercise, since such activity has the potential to decrease the concentrations of certain proinflammatory molecules, such as reactive C protein, tumor necrosis factor alpha and interleukin 6. Objective: To analyze the LGSI response when intervening with a high-intensity interval training in young obese adults between 18 to 30 years. Materials and methods: The present study is defined as a simple randomized clinical trial. Participants will be randomized into one of two groups of intervention; 1: High-intensity interval training (HIIT), and the control group with moderate-intensity continuous training (MICT). The interventions will be 3 times a week for 2 months, completing a total of 24 sessions. The HIIT group will carry out the activities at high intensity (85 to 95% maximum heart rate) aerobic type training; density of 1 minute at high interval followed by 2 minutes of low interval with a total time of 15 minutes (plus 5 more minutes of warm-up and 5 of cool-down exercises). While the MICT group will carry out the activities with a moderate intensity (60 to 75% maximum heart rate) aerobic type training reaching a total time of 25 to 45 minutes (considering 5 minutes of warm-up and 5 of cool-down exercises). Physical activity will be monitored using a Polar brand heart rate sensor (model H9). Anthropometric, biochemical, and inflammatory assessments will be monitored at baseline, at 4 weeks (mid-intervention), and at 8 weeks (end of intervention). Biochemical parameters will be determined by dry chemistry (Vitros 350), anthropometry by electrical bioimpedance (Inbody 370), and inflammatory markers by blood count and ProQuantum Immunoassay technology. Infrastructure: Institute of Translational Nutrigenomics and Nutrigenomics, University Center for Health Sciences, University of Guadalajara.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable obesity

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

May 3, 2022

Last Update Submit

October 19, 2023

Conditions

Keywords

High-intensity Interval TrainingSystemic InflammationObesity

Outcome Measures

Primary Outcomes (1)

  • Serum levels of IL-6 between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.

    Compare serum levels of IL-6 between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.

    Change from baseline of IL-6 at 4 and 8 weeks

Secondary Outcomes (9)

  • Waist circumference between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity between 18 and 30 years.

    Change from baseline of waist circumference between a high-intensity interval training vs moderate-intensity continuous training at 4 and 8 weeks

  • Serum levels of TNFα between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.

    Change from baseline of TNFα at 4 and 8 weeks

  • Serum levels of ultrasensitive reactive C protein between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.

    Change from baseline of ultrasensitive reactive C protein at 4 and 8 weeks

  • Serum levels of erythrocyte sedimentation rate between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.

    Change from baseline of erythrocyte sedimentation rate at 4 and 8 weeks

  • Serum levels of neutrophil-lymphocyte ratio between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.

    Change from baseline of neutrophil-lymphocyte ratio at 4 and 8 weeks

  • +4 more secondary outcomes

Study Arms (2)

High-intensity Interval Training

EXPERIMENTAL

Training is based on 5 circuits, with intervals of 1 minute (high intensity) by 2 minutes (low intensity), with a total training time of 15 minutes (plus 5 more minutes of warm-up and 5 of cool-down exercises). The high intervals will be performed with the following exercises: squat, reverse lunge \& knee-up, reverse jump and walkout pushup, while the low intervals were performed jogging. The heart rates of the study subjects will be calculated using the Astrand test and the progression criteria is going to be based on an increase in maximum heart rate of 85% to 95%. To monitor heart rate during training, a polar brand chest sensor, model H9, will be used.

Other: High-intensity Interval Training

Moderate-intensity continuous training

ACTIVE COMPARATOR

Continuous aerobic training (jogging). Also, the heart rates of the study subjects will be calculated using the Astrand test and the progression criteria is going to be based on an increase in maximum heart rate from 60% to 75% and an increase in training time from 25 to 45 minutes (considering 5 minutes of warm-up and 5 of cool-down exercises). To monitor heart rate during training, a polar brand chest sensor, model H9, will be used as well.

Other: Moderate-intensity continuous training

Interventions

Training is based on 5 circuits, with intervals of 1 minute (high intensity) by 2 minutes (low intensity), with a total training time of 15 minutes (plus 5 more minutes of warm-up and 5 of cool-down exercises). The high intervals will be performed with the following exercises: squat, reverse lunge \& knee-up, reverse jump and walkout pushup, while the low intervals were performed jogging. The heart rates of the study subjects will be calculated using the Astrand test and the progression criteria is going to be based on an increase in maximum heart rate of 85% to 95%. To monitor heart rate during training, a polar brand chest sensor, model H9, will be used.

High-intensity Interval Training

Continuous aerobic training (jogging). Also, the heart rates of the study subjects will be calculated using the Astrand test and the progression criteria is going to be based on an increase in maximum heart rate from 60% to 75% and an increase in training time from 25 to 45 minutes (considering 5 minutes of warm-up and 5 of cool-down exercises). To monitor heart rate during training, a polar brand chest sensor, model H9, will be used as well.

Moderate-intensity continuous training

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Young adults, between 18 and 30 years.
  • BMI ≥ 30-39.9 kg/m2
  • How signed the informed consent
  • Additionally, it is necessary that they have computer equipment, electronic tablet, or smart cell phone, as well as access to electricity and the Internet.

You may not qualify if:

  • Participants who smoke
  • Presence of any of the following comorbidities: hypothyroidism, type 1 diabetes mellitus, type 2 diabetes mellitus, arterial hypertension, oncological pathology, immunological or rheumatic diseases.
  • Consumption of nitrates and anticalcium drugs during the 4 days prior to the start of the investigation and beta blockers, hypoglycemic drugs 7 days prior to the start of the intervention.
  • Pregnant or breastfeeding
  • Men who consume more than 40 g/day of alcohol or women who consume more than 20 g/day
  • Postural and biomechanical alterations (knee, foot or spine)
  • Previous diagnosis and less than 6 months of COVID 19
  • Previous diagnosis of HIV +
  • Previous diagnosis of periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Abd El-Kader SM, Al-Jiffri OH. Aerobic exercise modulates cytokine profile and sleep quality in elderly. Afr Health Sci. 2019 Jun;19(2):2198-2207. doi: 10.4314/ahs.v19i2.45.

    PMID: 31656505BACKGROUND
  • Ahn N, Kim K. Can Active Aerobic Exercise Reduce the Risk of Cardiovascular Disease in Prehypertensive Elderly Women by Improving HDL Cholesterol and Inflammatory Markers? Int J Environ Res Public Health. 2020 Aug 14;17(16):5910. doi: 10.3390/ijerph17165910.

    PMID: 32824020BACKGROUND
  • ASTRAND PO, RYHMING I. A nomogram for calculation of aerobic capacity (physical fitness) from pulse rate during sub-maximal work. J Appl Physiol. 1954 Sep;7(2):218-21. doi: 10.1152/jappl.1954.7.2.218. No abstract available.

    PMID: 13211501BACKGROUND
  • Barron-Cabrera E, Gonzalez-Becerra K, Rosales-Chavez G, Mora-Jimenez A, Hernandez-Canaveral I, Martinez-Lopez E. Low-grade chronic inflammation is attenuated by exercise training in obese adults through down-regulation of ASC gene in peripheral blood: a pilot study. Genes Nutr. 2020 Aug 27;15(1):15. doi: 10.1186/s12263-020-00674-0.

    PMID: 32854610BACKGROUND
  • Feito Y, Heinrich KM, Butcher SJ, Poston WSC. High-Intensity Functional Training (HIFT): Definition and Research Implications for Improved Fitness. Sports (Basel). 2018 Aug 7;6(3):76. doi: 10.3390/sports6030076.

    PMID: 30087252BACKGROUND
  • Gallo-Villegas J, Aristizabal JC, Estrada M, Valbuena LH, Narvaez-Sanchez R, Osorio J, Aguirre-Acevedo DC, Calderon JC. Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET). Trials. 2018 Feb 27;19(1):144. doi: 10.1186/s13063-018-2541-7.

    PMID: 29482601BACKGROUND
  • Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.

    PMID: 22289907BACKGROUND
  • Fisher G, Brown AW, Bohan Brown MM, Alcorn A, Noles C, Winwood L, Resuehr H, George B, Jeansonne MM, Allison DB. High Intensity Interval- vs Moderate Intensity- Training for Improving Cardiometabolic Health in Overweight or Obese Males: A Randomized Controlled Trial. PLoS One. 2015 Oct 21;10(10):e0138853. doi: 10.1371/journal.pone.0138853. eCollection 2015.

    PMID: 26489022BACKGROUND
  • Furuncuoglu Y, Tulgar S, Dogan AN, Cakar S, Tulgar YK, Cakiroglu B. How obesity affects the neutrophil/lymphocyte and platelet/lymphocyte ratio, systemic immune-inflammatory index and platelet indices: a retrospective study. Eur Rev Med Pharmacol Sci. 2016 Apr;20(7):1300-6.

    PMID: 27097950BACKGROUND
  • Ihalainen JK, Schumann M, Eklund D, Hamalainen M, Moilanen E, Paulsen G, Hakkinen K, Mero AA. Combined aerobic and resistance training decreases inflammation markers in healthy men. Scand J Med Sci Sports. 2018 Jan;28(1):40-47. doi: 10.1111/sms.12906. Epub 2017 Jun 13.

    PMID: 28453868BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Erika Martinez-Lopez, PhD

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika Martinez-Lopez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2022

First Posted

January 26, 2023

Study Start

November 30, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share