Randomized Controlled Clinical Trial on the Anti-inflammatory Effect of a Sustainable Dietary Strategy in Adults With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Change in relative abundance of AM
研究概览
简要总结
The goal of this randomized clinical trial is to compare an antiinflammatory and environmentally friendly dietary strategy (AIA-D) designed based on the planetary health diet recommendations translated to the regional context and including nutrients related to antiinflammatory responses with an active control diet based on general healthy diet recommendations (CONV-D) in adults from 18 to 50 years of age with obesity (body mass index ≥30 kg/m2). The main questions it aims to answer are:
- If the intervention with AIA-D will cause a significant decrease at the end of the intervention (six weeks) in lipopolysaccharide-binding protein (LBP) compared to CONV-D.
- If intervention with AIA-D will cause a significant increase at the end of the intervention (six weeks) in the relative abundance of two specific bacteria genera (AM and FP) when compared to CONV-D.
Participants will:
- Sign the informed consent.
- Provide two peripheral blood samples (taken by our trained professionals).
- Provide two samples of feces.
- Allow anthropometric (body weight, height, hip and waist circumferences) blood pressure measurements on two occasions.
- Respond to 24 h dietary recall on two occasions.
- Attend the 1-hour group sessions requested (three for AIA-D and one for CONV-D).
- Follow the dietary recommendations provided.
- Be willing to participate in social media groups to receive information and follow up during the six weeks of the intervention.
Researchers will compare an antiinflammatory and environmentally friendly strategy (AIA-D) with an active control diet (CONV-D) based on general healthy diet recommendations to see if AIA-D decreases metabolic endotoxemia measured through LBP serum levels and increase the relative abundance of AM and FP, compared to CONV-D.
详细描述
This randomized clinical trial proposes to evaluate an environmentally friendly dietary strategy (AIA-D) designed based on the planetary health diet recommendations translated to the regional context and including nutrients related to anti-inflammatory responses that can decrease metabolic endotoxemia and promote FP and AM growth associated with anti-inflammatory effects and good intestinal health compared to an active control diet (CONV-D) general healthy diet recommendations.
Primary hypothesis: The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity (body mass index ≥30 kg/m2) will cause a significant decrease at the end of the intervention (six weeks) in the levels of lipopolysaccharide-binding protein (metabolic endotoxemia), and significantly increase the relative abundance of AM and FP, when compared to general healthy diet recommendations.
Secondary hypotheses: The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity (body mass index ≥30 kg/m2) will cause a significant increase at the end of the intervention (six weeks) in the relative abundance of Prevotella, when compared to general healthy diet recommendations.
The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity (body mass index ≥30 kg/m2) will cause a significant decrease at the end of the intervention (six weeks) of body weight, percentage of body fat, body mass index, circumferences of waist and hip when compared to general healthy diet recommendations.
The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity (body mass index ≥30 kg/m2) will improve blood pressure more than the general healthy diet recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assignor to each group: The assignment of the people to the comparison groups will be carried out by the statistician responsible for the project. The statistician will not participate in any other project stage (registration, intervention, or measurements).
Researcher in charge of the database: A person from outside the workgroup will assign codes to the participants enrolled in the study to prevent the person entering the data into the database from identifying the intervention group they belong to.
Investigator in charge of the analysis of serum and stool samples: The same codes will be used to label the biological samples so that the person carrying out the interleukin and intestinal microbiota analyses cannot identify the intervention group to which they belong.
The keys will be revealed at the end of the statistical analyses.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obesity according to body mass index: ≥ 30 kg/m2
- •Willingness to participate and sign the consent form.
- •Willingness to follow the dietary recommendations of the protocol.
- •Have access to the internet and an electronic device.
排除标准
- •Clinically diagnosed with hyperglycemia, hypertension, cardiovascular disease, renal disease, hepatic disease, immunosuppression, or another metabolic disease.
- •Being under a dietary restriction regimen or pharmacological treatment to lose weight.
- •Consuming dietary supplements for at least six months (vitamins, fatty acids, probiotics, prebiotics).
- •Being under treatment with antibiotics or anti-inflammatory drugs in the last three months.
- •Having bariatric surgery.
- •Being pregnant or lactating.
- •Present gastrointestinal disease
- •Present Coronavirus disease (COVID-19) symptoms
- •Develop diseases that affect body weight
- •Becoming pregnant
- •Withdrawal of informed consent.
结局指标
主要结局
Change in relative abundance of AM
时间窗: Baseline to six weeks
According to the manufacturer's instructions, total DNA will be extracted from fecal samples and quantified by a spectrophotometer, where the ratio of 1.8-2.0 (260/280) is acceptable. DNA samples will be stored at -80°C until analysis. AM will be amplified from DNA extracted from fecal samples by quantitative polymerase chain reaction (qPCR). A specific set of primers will be used. The relative expression of the gen (relative abundance) will be calculated. The 16S ribosomal RNA (16S) (V4) normalizing gen will be used for analysis.
Change in Lipopolysaccharide-binding protein (LBP).
时间窗: Baseline to six weeks
Peripheral blood samples will be taken before and after the intervention, centrifuged for serum extraction, and stored at -80°C until analysis. ELISA kits were used to quantify LBP.
Change in relative abundance of FP
时间窗: Baseline to six weeks
According to the manufacturer's instructions, total DNA will be extracted from fecal samples and quantified by a spectrophotometer, where the ratio of 1.8-2.0 (260/280) is acceptable. DNA samples will be stored at -80°C until analysis. FP will be amplified from DNA extracted from fecal samples by quantitative polymerase chain reaction (qPCR). A specific set of primers will be used. The relative expression of the gen (relative abundance) will be calculated. The 16S ribosomal RNA (16S) (V4) normalizing gen will be used for analysis.
次要结局
- Change in abundance of Prevotella(Baseline to six weeks)
- Change in waist circumference(Baseline to six weeks)
- Change in percentage of body fat(Baseline to six weeks)
- Change in hip circumference(Baseline to six weeks)
- Change in body weight(Baseline to six weeks)
- Change in the dietary inflammatory index.(Baseline to six weeks)
- Change in body mass index(Baseline to six weeks)
- Change in waist-to-hip ratio(Baseline to six weeks)
- Change in blood pressure(Baseline to six weeks)
- Retention(Baseline to six weeks)
研究者
Silvia Yolanda Moya Camarena
Principal Investigator
Centro de Investigación en Alimentación y Desarrollo A.C.