NCT04920409

Brief Summary

Obesity is one of the major health problems worldwide. The consumption of healthy-dietary patterns can be difficult in some countries due to the availability of certain foods. Suggestion of alternative foods could be a necessity. The purpose of this study was to evaluate the effect of a dietary pattern consisting of fruit, avocado, whole-grains and trout (FAWGT) on postprandial gene expression, insulinemia and lipemia in Colombian obese people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2018

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

January 6, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

May 25, 2021

Last Update Submit

June 8, 2021

Conditions

Obesity

Keywords

ObesityDietPostprandial stateGene expressionInflammationLipemiaInsulinemia

Outcome Measures

Primary Outcomes (6)

  • Relative expression of the NFKB1 gene

    RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.

    8 weeks

  • Relative expression of the Interleukin 6 (IL6) gene

    RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.

    8 weeks

  • Relative expression of the tumoral necrosis factor (TNF) gene

    RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.

    8 weeks

  • Relative expression of the Interleukin 1 B (IL1B) gene

    RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state..

    8 weeks

  • Relative expression of the matrix metallopeptidase 9 (MMP)) gene

    RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.

    8 weeks

  • Relative expression of the nuclear factor, erythroid 2 like 2 (NFE2L2) gene

    RNA extraction from mononuclear cells, reverse transcription and DNA amplification.

    8 weeks

Secondary Outcomes (9)

  • Change from baseline of the gut microbiota

    8 weeks

  • Change from baseline of DNA methylation pattern

    8 weeks

  • Triglycerides

    8 weeks

  • Insulin

    8 weeks

  • Total Cholesterol

    8 weeks

  • +4 more secondary outcomes

Study Arms (2)

FAWGT Diet

EXPERIMENTAL

Composed of fruit, avocado, whole grains and trout

Other: FAWGT diet

Usual diet (UD)

ACTIVE COMPARATOR

Based on the food which the participants usually consumed prior to the study in their normal lifestyle.

Other: Usual diet (UD)

Interventions

FAWGT dietOTHER

Composed of 15% protein, 55% CH and 30% fat of which \< 10% was SFA, 14% MUFA and 6% PUFA in the overall total caloric content.

FAWGT Diet
Usual diet (UD)OTHER

Consisted of 16% protein, 54% carbohydrates (CH) and 30% fat of which 15% was saturated fat (SFA), 10% monounsaturated fat (MUFA) and 5% polyunsaturated fat (PUFA)in relation to the total caloric content

Usual diet (UD)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Body mass index (BMI) ≥ 30 Kg/m\^2.
  • Clinical: hypertensive and dyslipidemic participants.

You may not qualify if:

  • Age \< 40 or \> 65 years
  • Patients unable to follow a protocol.
  • Psychiatric diseases
  • Renal Insufficiency
  • Chronic Hepatopathy
  • Active Malignancy
  • Chronic obstructive pulmonary disease
  • Diseases of the digestive tract Endocrine disorders
  • Smokers.
  • Regular alcohol consumers.
  • Participants who were in weight reduction programs
  • Prescribed hypolipidaemic medication
  • Prescribed anti-inflammatory medication
  • Kidney or liver dysfunction.
  • Diabetes or other endocrine disorders.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Comfamiliar Risaralda

Pereira, Risaralda Department, 16000, Colombia

Location

Related Publications (8)

  • Hurt RT, Kulisek C, Buchanan LA, McClave SA. The obesity epidemic: challenges, health initiatives, and implications for gastroenterologists. Gastroenterol Hepatol (N Y). 2010 Dec;6(12):780-92.

    PMID: 21301632BACKGROUND

  • Frigolet ME, Dong-Hoon K, Canizales-Quinteros S, Gutierrez-Aguilar R. Obesity, adipose tissue, and bariatric surgery. Bol Med Hosp Infant Mex. 2020;77(1):3-14. doi: 10.24875/BMHIM.19000115.

    PMID: 32115585BACKGROUND

  • Fernemark H, Jaredsson C, Bunjaku B, Rosenqvist U, Nystrom FH, Guldbrand H. A randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes. PLoS One. 2013 Nov 27;8(11):e79324. doi: 10.1371/journal.pone.0079324. eCollection 2013.

    PMID: 24312178BACKGROUND

  • Koch W. Dietary Polyphenols-Important Non-Nutrients in the Prevention of Chronic Noncommunicable Diseases. A Systematic Review. Nutrients. 2019 May 9;11(5):1039. doi: 10.3390/nu11051039.

    PMID: 31075905BACKGROUND

  • Lopez-Miranda J, Williams C, Lairon D. Dietary, physiological, genetic and pathological influences on postprandial lipid metabolism. Br J Nutr. 2007 Sep;98(3):458-73. doi: 10.1017/S000711450774268X.

    PMID: 17705891BACKGROUND

  • Perez-Martinez P, Ordovas JM, Garcia-Rios A, Delgado-Lista J, Delgado-Casado N, Cruz-Teno C, Camargo A, Yubero-Serrano EM, Rodriguez F, Perez-Jimenez F, Lopez-Miranda J. Consumption of diets with different type of fat influences triacylglycerols-rich lipoproteins particle number and size during the postprandial state. Nutr Metab Cardiovasc Dis. 2011 Jan;21(1):39-45. doi: 10.1016/j.numecd.2009.07.008. Epub 2009 Oct 9.

    PMID: 19819118BACKGROUND

  • Uusitupa M, Hermansen K, Savolainen MJ, Schwab U, Kolehmainen M, Brader L, Mortensen LS, Cloetens L, Johansson-Persson A, Onning G, Landin-Olsson M, Herzig KH, Hukkanen J, Rosqvist F, Iggman D, Paananen J, Pulkki KJ, Siloaho M, Dragsted L, Barri T, Overvad K, Bach Knudsen KE, Hedemann MS, Arner P, Dahlman I, Borge GI, Baardseth P, Ulven SM, Gunnarsdottir I, Jonsdottir S, Thorsdottir I, Oresic M, Poutanen KS, Riserus U, Akesson B. Effects of an isocaloric healthy Nordic diet on insulin sensitivity, lipid profile and inflammation markers in metabolic syndrome -- a randomized study (SYSDIET). J Intern Med. 2013 Jul;274(1):52-66. doi: 10.1111/joim.12044. Epub 2013 Mar 2.

    PMID: 23398528BACKGROUND

  • Gomez-Marin B, Gomez-Delgado F, Lopez-Moreno J, Alcala-Diaz JF, Jimenez-Lucena R, Torres-Pena JD, Garcia-Rios A, Ortiz-Morales AM, Yubero-Serrano EM, Del Mar Malagon M, Lai CQ, Delgado-Lista J, Ordovas JM, Lopez-Miranda J, Perez-Martinez P. Long-term consumption of a Mediterranean diet improves postprandial lipemia in patients with type 2 diabetes: the Cordioprev randomized trial. Am J Clin Nutr. 2018 Nov 1;108(5):963-970. doi: 10.1093/ajcn/nqy144.

    PMID: 30475968BACKGROUND

MeSH Terms

Conditions

ObesityInflammationHyperlipidemias

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Study Officials

  • Clara H Gonzalez Correa, Doctor

    Universidad de Caldas

    STUDY DIRECTOR

  • Diana M Muñoz, PhD student

    Universidad de Caldas

    PRINCIPAL INVESTIGATOR

  • Oriol A Rangel Zuñiga, Postdoctor

    Instituto Maimonides de Investigación Biomédica de Córdoba

    PRINCIPAL INVESTIGATOR

  • Antonio Camargo, Postdoctor

    Instituto Maimonides de Investigacion Biomedica de Cordoba

    PRINCIPAL INVESTIGATOR

  • Elcy Y Astudillo Muñoz, Doctor

    Universidad Libre

    STUDY CHAIR

  • Gloria L Porras Hurtado, Postdoctor

    Clinica Comfamiliar Risaralda

    STUDY CHAIR

  • Maite Sanchez Giraldo, PhD student

    Instituto Maimonides de Investigación Biomedica de Cordoba

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 9, 2021

Study Start

January 6, 2018

Primary Completion

June 18, 2018

Study Completion

June 18, 2018

Last Updated

June 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)