The Effects of Dietary Quinoa and Buckwheat Consumption on Weight Management and Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
This study aims to compare the effects of quinoa, buckwheat, rice, and bulgur consumption on dietary intake, anthropometric measurements, glycemic response, lipid profile, inflammatory markers, blood pressure, and intestinal microbiome in people with overweight and obesity. The primary hypotheses of the studies were given as follows:
Hypothesis 1:
H1: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet provides weight loss.
H0: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet does not provide body weight loss.
Hypothesis 2:
H2: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet affects glycemic response.
H0: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet does not affect glycemic response.
Hypothesis 3:
H3: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet affects the blood lipid profile.
H0: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet does not affect the blood lipid profile.
Hypothesis 4:
H4: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet changes the composition of the gut microbiome.
H0: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet does not change the composition of the gut microbiome.
Hypothesis 5:
H5: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet increases alpha diversity in the intestinal microbiome.
HO: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet does not increase alpha diversity in the intestinal microbiome.
Hypothesis 6:
H6: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet increases beta diversity in the intestinal microbiome.
HO: In people with overweight and obesity, the addition of quinoa and buckwheat to the diet does not increase beta diversity in the intestinal microbiome.
详细描述
The study is designed as a randomized, controlled clinical trial in which participants will be allocated into four groups (quinoa, buckwheat, bulgur, and rice groups), each consisting of 31 or 32 pre-obese/obese adults. During the 28-day intervention period, participants' diets were supplemented with 40 g/day of quinoa (Chenopodium quinoa), buckwheat (Fagopyrum esculentum), bulgur wheat (Triticum durum), or rice (Oryza sativa).
Weekly face-to-face visits were conducted throughout the intervention to collect anthropometric measurements and dietary intake records and to assess intervention compliance and physical activity level.
At baseline and at the end of the intervention, physical examinations were performed, blood and fecal samples were collected, blood pressure was measured, and anthropometric measurements and dietary intake records were evaluated. Serum levels of triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, glucose, insulin, fructosamine, adiponectin, C-reactive protein, malondialdehyde, uric acid, lipopolysaccharide, TNF-alpha, IL-6, zonulin, and lipopolysaccharides will be analyzed. Additionally, fecal samples will be analyzed to reveal any possible changes in gut microbiome. Given the scarcity of clinical studies in this field, this study is expected to contribute to addressing the lack of high-level clinical evidence in the literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 25 and 45
- •Healthy People
- •Having a body mass index between 25 and 35 kg/m²
排除标准
- •To have a diagnosis of chronic and/or psychiatric illness
- •To have diagnosis of celiac disease
- •To be using antibiotics
- •To be using medication and/or nutritional supplements that can affect body weight
- •To be using medication and/or nutritional supplements that can affect glycemic response
- •To be using medication and/or nutritional supplements that can affect lipid profile
- •To use medication and/or nutritional supplements that can affect intestinal microbiota composition (such as antibiotics, probiotics, prebiotics) in the last three months
- •To have food allergies and/or food intolerances
- •To be a professional athlete
- •To be pregnant or breastfeeding
- •To be in postmenopausal period
- •To have followed a specific diet aimed at reducing body weight in the last 6 months
- •To regularly consume quinoa or buckwheat in the diet
- •To be unable to continue with weekly interviews
- •To show less than 80% compliance with the diet
- •To not give consent for the research
研究组 & 干预措施
Quinoa Group
Participants' diets were supplemented with 40 g of red quinoa per day for 4 weeks. Participants were instructed to boil red quinoa without adding any other ingredients.
干预措施: quinoa (Dietary Supplement)
Bulgur Wheat Group
Participants' diets were supplemented with 40 g of bulgur wheat per day for 4 weeks. Participants were instructed to boil bulgur wheat without adding any other ingredients.
干预措施: Bulgur wheat (Dietary Supplement)
Rice group
Participants' diets were supplemented with 40 g of rice per day for 4 weeks. Participants were instructed to boil rice without adding any other ingredients.
干预措施: Rice (Dietary Supplement)
buckwheat group
Participants' diets were supplemented with 40 g of buckwheat per day for 4 weeks. Participants were instructed to boil buckwheat without adding any other ingredients.
干预措施: Buckwheat (Dietary Supplement)
结局指标
主要结局
Weight loss
时间窗: From the beginning of the study to the end of the 4-week intervention period (up to 4 weeks), with measurements taken once a week.
Body weight and body composition will be measured with a bioelectrical impedance analysis-based body analyzer.
Blood lipid levels (mg/dL)
时间窗: At the beginning of the study and at the end of 4-weeks intervention period
Total cholesterol (mg/dL), LDL cholesterol (mg/dL), HDL cholesterol (mg/dL), and triglyceride levels (mg/dL) will be analyzed in blood serum.
Blood glucose levels (mg/dL) during a 75 g oral glucose tolerance test (OGTT) procedure
时间窗: At the beginning of the study and at the end of the 4-week intervention period, during each assessment, blood samples will be collected at 0. Minutes (fasting) and 30, 60, 90, and 120 minutes following the 75 g oral glucose load.
Fasting glucose levels (0.minutes, before the 75 g oral glucose load) and postprandial glucose levels (30, 60, 90, and 120 minutes following the 75 g oral glucose load) will be assessed in blood serum during the 75 g oral glucose tolerance test procedure.
Blood insulin levels (µIU/mL) during a 75 g oral glucose tolerance test (OGTT) procedure
时间窗: At the beginning of the study and at the end of the 4-week intervention period, during each assessment, blood samples will be collected at 0. Minutes (fasting) and 30, 60, 90, and 120 minutes following the 75 g oral glucose load.
Fasting insulin levels (0.minutes, before the 75 g oral glucose load) and postprandial insulin levels (30, 60, 90, and 120 minutes following the 75 g oral glucose load) will be assessed in blood serum during the 75 g oral glucose tolerance test procedure.
Changes in gut microbiome composition
时间窗: At the beginning of the study and at the end of 4-week intervention period
Changes in gut microbiome composition will be assessed in fecal samples
Changes in Alpha Diversity
时间窗: At the beginning of the study and at the end of 4-week intervention period
Changes in alpha diversity in intestinal microbiota will be evaluated.
Changes in Beta Diversity
时间窗: At the beginning of the study and at the end of 4-week intervention period
Changes in Beta Diversity in intestinal microbiota will be evaluated
次要结局
未报告次要终点
研究者
ZEHRA BUYUKTUNCER
Professor
Hacettepe University