Effect of an Antiinflammatory Diet on Postprandial Gene Expression of Mononuclear Cells of Adult Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Relative expression of the tumoral necrosis factor (TNF) gene
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Body mass index (BMI) ≥ 30 Kg/m^
- •Clinical: hypertensive and dyslipidemic participants.
排除标准
- •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
- •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).
结局指标
主要结局
Relative expression of the tumoral necrosis factor (TNF) gene
时间窗: 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
时间窗: 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
时间窗: 8 weeks
RNA extraction from mononuclear cells, reverse transcription and DNA amplification.
Relative expression of the Interleukin 1 B (IL1B) gene
时间窗: 8 weeks
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state..
Relative expression of the NFKB1 gene
时间窗: 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
时间窗: 8 weeks
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
次要结局
- Total Cholesterol(8 weeks)
- HDL Cholesterol(8 weeks)
- VLDL Cholesterol(8 weeks)
- Change from baseline of DNA methylation pattern(8 weeks)
- Triglycerides(8 weeks)
- C-reactive protein (CRP)(8 weeks)
- Change from baseline of the gut microbiota(8 weeks)
- Insulin(8 weeks)
- LDL Cholesterol(8 weeks)
研究者
Diana M Munoz
Principal investigator
Universidad de Caldas