Effect of an Antiinflammatory Diet on Postprandial Gene Expression of Mononuclear Cells of Adult Obese Women

NCT ID: NCT04920409

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-06
• Study Completion Date: 2018-06-18

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.

Detailed Description

A randomized controlled crossover study was conducted. Volunteers underwent to two dietary models for 8 weeks each, including a 2 weeks washout diet between them. The order in which they started the interventions was randomized following a computerized assignment list using Excel software (Microsoft Office 2015, Excel 2013).

The primary endpoint was the postprandial gene expression of nuclear factor kappa B subunit 1 (NFKB1) gene. Based on previous studies , 20 individuals had to be studied to detect a 0.2 difference in the expression of the NKKB1 gene between diets with 0.05 significance level and 80 percentage power (type II error Z 0.2), assuming a 10 percentage drop-out rate.

The recruitment of participants was carried out according to the following steps:

1. Review of clinical histories of patients diagnosed with obesity, according to their Body Mass Index, ascribed to the chronic non-communicable diseases program of the Clinica Comfamiliar Risaralda in the city of Pereira Colombia.

2. Telephone call to invite the participants who met the inclusion criteria to participate in the study.

3. Appointment prior to the start of the study to take a blood sample to corroborate the inclusion criteria. With this sample the following tests were performed: blood glucose, lipid profile, thyroid stimulating hormone (TSH), C-reactive protein ( and complete blood count.

This process was carried out by personnel not involved in the research. The results obtained were compared with the clinical history.

The diets followed during the intervention periods were: (1) a diet consisting mainly of the consumption of fruit, avocado and other vegetables, whole grains and trout typical of the colombian coffee region (FAWGT) (experimental diet), and (2) the usual diet consumed by the participants in their normal lifestyle (UD).

At the beginning of the dietary intervention period, each participant was given an individualized food guide containing the suggested food group and portions, with a wide variety of foods allowed for greater adherence to the diet. In addition, specific times for consumption of the foods and precise instructions for the dietary intervention were given. In addition, the subjects were given a talk advising them how to quantify the portions, which would later be converted into grams according to the procedure described

The food portions were standardized with all the participants using synthetic models, adapted according to the Colombian nutritional guidelines, so that they could provide a more accurate report of the portions consumed during the intervention. In addition, a postprandial studies were carried out at the beginning of the study (pre-intervention) and another after 8 weeks of dietary intervention (post-intervention).

The participants were given an appointment at the health center at 7.00 am, after at least 12 hours of fasting and a 5 day abstinence from alcohol. They consumed a breakfast based on the same composition of the diet in which they were randomized for the dietary intervention period. The blood samples were obtained by veni-puncture at baseline and 4 hours after breakfast. During the postprandial period, the participants did not consume any more food, although they were allowed to drink water. The breakfasts were composed of the following foods: FAWGT diet; whole-grain arepa (with unrefined corn flour), cheese, oats, granadilla, mango, linseed, nuts, almonds, peanuts and yogurt. Usual diet; egg, cheese, butter, whole milk, traditional white arepa (with re-fined corn flour), traditional buñuelo (made from wheat flour with cheese), coffee and sugar.

Before starting the dietary intervention period (Pre-intervention), at the midpoint of the study (week 4) and at the end (week 8), all the participants completed three 24-hour recalls (2 non-consecutive weekdays and one weekend day) to obtain information about food, ingredients and preparations consumed in the same units of measurement (grams).

In addition, a weekly telephone call was made to answer any questions relating to the diet (recipes, menu and quantities) and to motivate adherence to the assigned dietary model.

Moreover, in week four of each intervention, the participants attended the hospital for an interview with the main researcher in order to take anthropometric measurements, evaluate the follow-up of the dietary instructions and answer any questions that may have arisen during the intervention, and motivate them to continue with the study. To collect the information on food consumption, formats and questionnaires previously published by the research group were used.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

FAWGT Diet

Composed of fruit, avocado, whole grains and trout

Group Type: EXPERIMENTAL

FAWGT diet

Intervention Type: OTHER

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.

Usual diet (UD)

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

Group Type: ACTIVE_COMPARATOR

Usual diet (UD)

Intervention Type: 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

Interventions

FAWGT diet

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.

Intervention Type: OTHER

Usual diet (UD)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.
• Chronic inflammatory conditions.
• Patients participating in other Clinical trials (in the enrollment moment or 30 days prior).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Libre

UNKNOWN

Sponsor Role: collaborator

Clínica Comfamiliar Risaralda

UNKNOWN

Sponsor Role: collaborator

Universidad de Caldas

OTHER

Sponsor Role: lead

Responsible Party

Diana M Munoz

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clara H Gonzalez Correa, Doctor

Role: STUDY_DIRECTOR

Universidad de Caldas

Diana M Muñoz, PhD student

Role: PRINCIPAL_INVESTIGATOR

Universidad de Caldas

Oriol A Rangel Zuñiga, Postdoctor

Role: PRINCIPAL_INVESTIGATOR

Instituto Maimonides de Investigación Biomédica de Córdoba

Antonio Camargo, Postdoctor

Role: PRINCIPAL_INVESTIGATOR

Instituto Maimonides de Investigacion Biomedica de Cordoba

Elcy Y Astudillo Muñoz, Doctor

Role: STUDY_CHAIR

Universidad Libre

Gloria L Porras Hurtado, Postdoctor

Role: STUDY_CHAIR

Clinica Comfamiliar Risaralda

Maite Sanchez Giraldo, PhD student

Role: STUDY_CHAIR

Instituto Maimonides de Investigación Biomedica de Cordoba

Locations

Clinica Comfamiliar Risaralda

Pereira, Risaralda Department, Colombia

Countries

Colombia

References

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.

Reference Type: BACKGROUND

PMID: 21301632 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32115585 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24312178 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31075905 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17705891 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19819118 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23398528 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30475968 (View on PubMed)

Other Identifiers

0406716

Identifier Type: -

Identifier Source: org_study_id