NCT05713461

Brief Summary

This project aims to develop an intervention on healthy habits based on physical exercise and nutritional education in people with obesity. It is accepted that exercise and nutrition are keys to controlling body weight. People with obesity frequently present with metabolic syndrome and a low-grade inflammatory state. It is not known what should be the most effective training load/dose (duration, intensity, type of exercise) to improve health indicators related to metabolic syndrome and lipo-inflammation, and body composition in people with obesity. A large-scale randomized controlled trial (RCT) will be essential to better understand the type and characteristics of training load/dose most effective in counteracting the detrimental effects of obesity. The aim of this trial in 50 obese women was to answer the following questions:

  • Does the training program improve physical fitness?
  • Does the training program improve body composition?
  • Does the training program improve the state of chronic low-grade inflammation?
  • Does the training program improve the quality of life and perceived health?
  • Do people with obesity and metabolic syndrome respond in the same way to training?
  • what is the effect of four weeks of detraining?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 26, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

January 7, 2023

Last Update Submit

October 13, 2023

Conditions

ObesityOverweight and ObesityOverweight or Obesity

Keywords

lipoinflammationmetabolic syndrometrainingoverweightsedentary lifestyle

Outcome Measures

Primary Outcomes (7)

  • Change in low-grade chronic inflammation

    Plasma levels of inflammatory and lipoinflammatory markers Multiplex Quantitative measurement of 40 human adipokines in plasma (cytokine antibody arrays (pg/ml) : 1. Adiponectin 2. Adipsin 3. AgRP 4. ANGPTL4 5. BDNF 6. Chemerin 7. CRP 8. GH 9. IFNg 10. IGFBP-1 11. IGFBP-2 12. IGF-I 13. IL-10 14. IL-12p40 15. IL-12p70 16. IL-1b 17. IL-1ra 18. IL-6 19. IL-8 20. Insulin 21. Leptin 22. Lipocalin-2 23. MSPa 24. OPG 25. PAI-1 26. PDGF-BB 27. Pepsinogen 1 28. Pepsinogen 2 29. Procalcitonin 30. Prolactin 31. RANTES 32. RBP4 33. Resistin 34. SAA 35. TGFb1 36. TSP-1 37. TNF RI 38. TNF RII 39. TNFa 40. VEGF

    from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  • Change in body composition

    Body composition by DEXA. Main body composition components: * Body Fat Mass (g) * Body Lean Mass (g) * Body Bone mineral content (g) * Body Total mass (g) * Estimated Visceral Adipose Tissue (g) * BMI: kg/m\^2

    from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  • Change in physical fitness (resistance; muscular strength)

    * Maximum dynamic strength of the upper body (bench press; kg) * Lower body maximal dynamic strength (leg press; kg) * Grip maximal isometric strength (handgrip: kg)

    from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  • Change in physical fitness (aerobic power; VO2max)

    Aerobic power. VO2 max. (estimated from the 6-minute walk test; ml/kg/min)

    From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  • Change in physical fitness (Coordination; balance)

    Balance test one leg (seconds)

    From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  • Change in perceived health and perceived quality of life

    perceived health by questionnaire (SF-12). The SF-12 response options are Likert-type scales that assess intensity or frequency. The number of response options ranges from three to six, depending on the item, and each question receives a value that is later transformed into a scale from 0 to 100.

    from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  • Change in healthy eating habits

    Mediterranean Diet Adherence Screener (MEDAS). MEDAS consists of 12 questions on food consumption frequency and 2 questions on food intake habits considered characteristic of the Spanish Mediterranean diet. Each question was scored 0 or 1.

    from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

Secondary Outcomes (5)

  • Change eating habits

    Every week, from baseline (0 weeks) to follow-up (10 weeks)

  • Change in Biochemistry Determinations In Plasma (lipidic profile)

    From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  • Change in Biochemistry Determinations In Plasma (glucose metabolism)

    From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  • Change in Biochemistry Determinations In Plasma (Enzymes of fatigue or muscular damage)

    From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

  • Change in Biochemistry Determinations In Plasma (protein metabolism)

    From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)

Study Arms (2)

obese women without metabolic syndrome

EXPERIMENTAL

Women with obesity and without metabolic syndrome

Behavioral: exercise training programBehavioral: Feeding training

obese women with metabolic syndrome

EXPERIMENTAL

Women with obesity and with metabolic syndrome

Behavioral: exercise training programBehavioral: Feeding training

Interventions

exercise training programBEHAVIORAL

Adapted Interval Training Intervention, three days a week, 10 weeks. Warm-up 10': Joint mobility and cardiovascular activation Main part: Resistance training circuit for strengthening the main muscle groups. Cool down Flexibility and CORE

Also known as: interval training program
obese women with metabolic syndromeobese women without metabolic syndrome
Feeding trainingBEHAVIORAL

Two workshops on healthy eating habits (Week 1 and week 5). Food Frequency Questionnaires (weekly). Feedback weekly. Mediterranean Diet Adherence Screener (MEDAS). The dietary intervention will be based on the nutritional recommendations based on the Mediterranean diet, according to the evidence from the PREDIMED trial.

obese women with metabolic syndromeobese women without metabolic syndrome

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The recruitment of participants would be carried out through advertising in the press, social networks, and electronic media.
  • Sex: Female
  • Caucasian
  • Age. women from 35 years to 65 years.
  • BMI: \>29
  • Abdominal perimeter: \>90 cm women
  • No known Diabetes
  • No known cancer
  • No Known lung disease
  • No known cardiovascular disease
  • No known thyroid disease
  • No known liver disease
  • No known autoimmune disease
  • No other endocrine disorder causes obesity
  • No current treatment with anti-obesity medication
  • +11 more criteria

You may not qualify if:

  • Diagnosis of pathology that involves an inflammatory process in the last year.
  • Objective findings that contraindicate participation in intensive exercise
  • The language barrier, mental incapacity, unwillingness or inability to understand the instruction of the study
  • Not completing 75% of the training sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIRFD Universidad Pablo de Olavide

Seville, 41013, Spain

Location

MeSH Terms

Conditions

ObesityOverweightMetabolic SyndromeSedentary Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Study Officials

  • Jose A Gonzalez-Jurado, PhD

    Universidad Pablo de Olavide de Sevilla

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants do not know if they have metabolic syndrom Physical training supervisors do not know if participants have metabolic syndrom
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: To compare the effects of an interval training program in obese women with metabolic syndrom vs obese women without metabolic syndrom
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 7, 2023

First Posted

February 6, 2023

Study Start

October 26, 2022

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

October 16, 2023

Record last verified: 2023-10

Locations

ES(1)