NCT02903459

Brief Summary

The aim of this study is analyze the relationship between the density of visceral and subcutaneous fat and cellulite with the lumbar lordosis degree.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

August 1, 2016

Last Update Submit

March 6, 2018

Conditions

Keywords

Central FatSubcutaneous FatLumbar Lordosis DegreeCellulite

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Lumbar Lordosis by analysing photos of the lateral right side of the participants

    We used photogrammetry for this evaluation. We marked the anatomical points (T11, L1, S2 and Antero-superior Iliac Spine) with isopod balls. We took a picture of the right lateral view of the participant. Finally we used the SAPo software to measure free angles to determinate lumbar lordosis degree.

    Day 1

Secondary Outcomes (7)

  • Body Mass Index

    Day 1

  • Perimeters measurements using a tape-measure at waist level and at trochanters level at the end of expiration

    Day 1

  • Skinfold measures

    Day 1

  • Bioimpedance Balance

    Day 1

  • Ecograph

    Day 1

  • +2 more secondary outcomes

Other Outcomes (2)

  • International Physical Activity Questionnaire

    Day 1

  • Food Frequency Questionnaire

    Day 1

Study Arms (4)

Males

Evaluation of body mass index, determination of waist-to-hip ration and waist-to-height ration, using perimetry; evaluation of 7 skinfold according to the model 7-site-skinfold Equation, by Jackson and Pollock, and photogrammetry (to evaluate the lumbar lordosis degree) in males aged between 18 and 26.

Other: Transversal Study so there is no intervention

Young Adults

Evaluation of abdominal thickness, percentage of abdominal fat and photogrammetry (to evaluate the lumbar lordosis degree) in young adults females aged between 18-26.

Other: Transversal Study so there is no intervention

Adults

Evaluation of abdominal thickness, percentage of abdominal fat and photogrammetry (to evaluate the lumbar lordosis degree) in adult females aged between 40-60.

Other: Transversal Study so there is no intervention

Females

Evaluation of body mass index, determination of waist-to-hip ration and waist-to-height ration using perimetry, evaluation of 7 skinfold according to the model 7-site-skinfold Equation, by Jackson and Pollock, and photogrammetry (to evaluate the lumbar lordosis degree) in females aged between 18 and 26.

Other: Transversal Study so there is no intervention

Interventions

AdultsFemalesMalesYoung Adults

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All the comunity of the School of Allied Health Technologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andreia Noites

Vila Nova de Gaia, Porto District, 4400-303, Portugal

Location

Related Publications (13)

  • Jackson AS, Pollock ML. Generalized equations for predicting body density of men. Br J Nutr. 1978 Nov;40(3):497-504. doi: 10.1079/bjn19780152.

    PMID: 718832BACKGROUND
  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PMID: 12900694BACKGROUND
  • Siqueira, G. R., Alencar, G. G., Rocha, M. B. N., Silva, L. R., Moura, M. C. G. G., & Silva, G. A. P. (2015). Relação entre lordose lombar e depósito de gordura abdominal em adolescentes e adultos jovens. Revista Brasileira de Ciência e Movimento, 74-80.

    BACKGROUND
  • Power ML, Schulkin J. Sex differences in fat storage, fat metabolism, and the health risks from obesity: possible evolutionary origins. Br J Nutr. 2008 May;99(5):931-40. doi: 10.1017/S0007114507853347. Epub 2007 Nov 1.

    PMID: 17977473BACKGROUND
  • Lopes C, Aro A, Azevedo A, Ramos E, Barros H. Intake and adipose tissue composition of fatty acids and risk of myocardial infarction in a male Portuguese community sample. J Am Diet Assoc. 2007 Feb;107(2):276-86. doi: 10.1016/j.jada.2006.11.008.

    PMID: 17258965BACKGROUND
  • Kuo YL, Tully EA, Galea MP. Video analysis of sagittal spinal posture in healthy young and older adults. J Manipulative Physiol Ther. 2009 Mar-Apr;32(3):210-5. doi: 10.1016/j.jmpt.2009.02.002.

    PMID: 19362231BACKGROUND
  • Bazzocchi A, Filonzi G, Ponti F, Sassi C, Salizzoni E, Battista G, Canini R. Accuracy, reproducibility and repeatability of ultrasonography in the assessment of abdominal adiposity. Acad Radiol. 2011 Sep;18(9):1133-43. doi: 10.1016/j.acra.2011.04.014. Epub 2011 Jul 2.

    PMID: 21724427BACKGROUND
  • Noites A, Nunes R, Gouveia AI, Mota A, Melo C, Viera A, Adubeiro N, Bastos JM. Effects of aerobic exercise associated with abdominal microcurrent: a preliminary study. J Altern Complement Med. 2015 Apr;21(4):229-36. doi: 10.1089/acm.2014.0114.

    PMID: 25875939BACKGROUND
  • Nkengne A, Papillon A, Bertin C. Evaluation of the cellulite using a thermal infra-red camera. Skin Res Technol. 2013 Feb;19(1):e231-7. doi: 10.1111/j.1600-0846.2012.00633.x. Epub 2012 Jun 29.

    PMID: 22741614BACKGROUND
  • Goldman, M., & Hexsel, D. (2006). Cellulite: Pathophysiology and Treatment (i. healthcare Ed. 2ª edição ed.).

    BACKGROUND
  • FLIR. (2013). Flir E-Series.

    BACKGROUND
  • COMED. (2013). Company Comed.

    BACKGROUND
  • Corporation, T. (2006). Tanita: Monitoring Your Heath. Tanita Manual: InnerScan Body Composition Monitor

    BACKGROUND

MeSH Terms

Conditions

LordosisCellulite

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andreia Noites, PhD

    Escola Superior de Tecnologia da Saúde do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 1, 2016

First Posted

September 16, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Study Completion

July 1, 2017

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations