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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920409
• Other study ID #: 0406716
• Status: Completed
• Phase: N/A
• Start date: January 6, 2018
• Est. completion date: June 18, 2018

Study information

• Verified date: June 2021
• Source: Universidad de Caldas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 18, 2018
• Est. primary completion date: June 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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

Locations

Country	Name	City	State
Colombia	Clinica Comfamiliar Risaralda	Pereira	Risaralda

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Caldas	Clínica Comfamiliar Risaralda, Universidad Libre

Country where clinical trial is conducted

Colombia, 

References & Publications (8)

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. — View Citation

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

Gomez-Marin B, Gomez-Delgado F, Lopez-Moreno J, Alcala-Diaz JF, Jimenez-Lucena R, Torres-Peña 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. — View Citation

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. — View Citation

Koch W. Dietary Polyphenols-Important Non-Nutrients in the Prevention of Chronic Noncommunicable Diseases. A Systematic Review. Nutrients. 2019 May 9;11(5). pii: E1039. doi: 10.3390/nu11051039. — View Citation

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. Review. — View Citation

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. — View Citation

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, Jónsdóttir S, Thorsdottir I, Orešic M, Poutanen KS, Risérus 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative expression of the NFKB1 gene	RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.	8 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change from baseline of the gut microbiota	Stool deoxyribonucleic acid (DNA) extraction, library construction, sequencing and bioinformatic analysis.	8 weeks
Secondary	Change from baseline of DNA methylation pattern	Whole blood DNA extraction and Enzyme-Linked ImmunoSorbent Assay (ELISA)	8 weeks
Secondary	Triglycerides	Influence of diet on postprandial trygliceride	8 weeks
Secondary	Insulin	Influence of diet on postprandial insulinemia	8 weeks
Secondary	Total Cholesterol	Influence of diet on postprandial total Cholesterol	8 weeks
Secondary	LDL Cholesterol	Influence of diet on postprandial LDL Cholesterol	8 weeks
Secondary	HDL Cholesterol	Influence of diet on postprandial HDL Cholesterol	8 weeks
Secondary	VLDL Cholesterol	Influence of diet on postprandial VLDL Cholesterol	8 weeks
Secondary	C-reactive protein (CRP)	Influence of diet on postprandial CRP	8 weeks