Hacettepe University
Ankara, Sıhhiye, 06100, Turkey (Türkiye)
NCT Number: NCT07513610
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.
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Notify Me25 year–45 year
All sexes
Interventional
Not applicable
Ankara, Sıhhiye, 06100, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants consumed 40 g/d red quinoa during 4 weeks. Participants were instructed to consume red quinoa by boiling it without any other ingredients.
Participants consumed 40 g/d of buckwheat during 4 weeks. Participants were instructed to consume buckwheat by boiling it without any other ingredients.
Participants consumed 40 g/d rice during 4 weeks. Participants were instructed to consume rice by boiling it without any other ingredients.
Participants consumed 40 g/d of bulgur wheat during 4 weeks. Participants were instructed to consume bulgur wheat by boiling it without any other ingredients.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Hacettepe University
Other
The Effects of Dietary Quinoa and Buckwheat Consumption on Weight Management and Gut Microbiome
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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