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

Sponsor

Universidad de Caldas (Other)

Overall Status

Completed

CT.gov ID

NCT04920409

Collaborator

Universidad Libre (Other), Clínica Comfamiliar Risaralda (Other)

Enrollment

Location

Arms

5.4

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: FAWGT diet Other: Usual diet (UD)	N/A

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:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 6, 2018

Actual Primary Completion Date :

Jun 18, 2018

Actual Study Completion Date :

Jun 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FAWGT Diet Composed of fruit, avocado, whole grains and trout	Other: 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.
Active Comparator: Usual diet (UD) Based on the food which the participants usually consumed prior to the study in their normal lifestyle.	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

Arm

Intervention/Treatment

Experimental: FAWGT Diet

Composed of fruit, avocado, whole grains and trout

Other: 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.

Active Comparator: Usual diet (UD)

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

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

Outcome Measures

Primary Outcome Measures

Relative expression of the NFKB1 gene [8 weeks]
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Relative expression of the Interleukin 6 (IL6) gene [8 weeks]
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Relative expression of the tumoral necrosis factor (TNF) gene [8 weeks]
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Relative expression of the Interleukin 1 B (IL1B) gene [8 weeks]
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state..
Relative expression of the matrix metallopeptidase 9 (MMP)) gene [8 weeks]
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Relative expression of the nuclear factor, erythroid 2 like 2 (NFE2L2) gene [8 weeks]
RNA extraction from mononuclear cells, reverse transcription and DNA amplification.

Secondary Outcome Measures

Change from baseline of the gut microbiota [8 weeks]
Stool deoxyribonucleic acid (DNA) extraction, library construction, sequencing and bioinformatic analysis.
Change from baseline of DNA methylation pattern [8 weeks]
Whole blood DNA extraction and Enzyme-Linked ImmunoSorbent Assay (ELISA)
Triglycerides [8 weeks]
Influence of diet on postprandial trygliceride
Insulin [8 weeks]
Influence of diet on postprandial insulinemia
Total Cholesterol [8 weeks]
Influence of diet on postprandial total Cholesterol
LDL Cholesterol [8 weeks]
Influence of diet on postprandial LDL Cholesterol
HDL Cholesterol [8 weeks]
Influence of diet on postprandial HDL Cholesterol
VLDL Cholesterol [8 weeks]
Influence of diet on postprandial VLDL Cholesterol
C-reactive protein (CRP) [8 weeks]
Influence of diet on postprandial CRP

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Comfamiliar Risaralda	Pereira	Risaralda	Colombia	16000

Sponsors and Collaborators

Universidad de Caldas
Universidad Libre
Clínica Comfamiliar Risaralda

Investigators

Study Director: Clara H Gonzalez Correa, Doctor, Universidad de Caldas
Principal Investigator: 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
Study Chair: 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