- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513610
The Effects of Quinoa and Buckwheat on Weight Management and Gut Microbiome
The Effects of Dietary Quinoa and Buckwheat Consumption on Weight Management and Gut Microbiome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sıhhiye
-
Ankara, Sıhhiye, Turkey (Türkiye), 06100
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 25 and 45
- Healthy People
- Having a body mass index between 25 and 35 kg/m²
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Participants consumed 40 g/d red quinoa during 4 weeks.
Participants were instructed to consume red quinoa by boiling it without any other ingredients.
|
|
Experimental: 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.
|
Participants consumed 40 g/d of buckwheat during 4 weeks.
Participants were instructed to consume buckwheat by boiling it without any other ingredients.
|
|
Active Comparator: 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.
|
Participants consumed 40 g/d rice during 4 weeks.
Participants were instructed to consume rice by boiling it without any other ingredients.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss
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.
|
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.
|
|
Blood lipid levels (mg/dL)
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.
|
At the beginning of the study and at the end of 4-weeks intervention period
|
|
Blood glucose levels (mg/dL) during a 75 g oral glucose tolerance test (OGTT) 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 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.
|
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.
|
|
Blood insulin levels (µIU/mL) during a 75 g oral glucose tolerance test (OGTT) 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.
|
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.
|
|
Changes in gut microbiome composition
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
|
At the beginning of the study and at the end of 4-week intervention period
|
|
Changes in Alpha Diversity
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.
|
At the beginning of the study and at the end of 4-week intervention period
|
|
Changes in Beta Diversity
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
|
At the beginning of the study and at the end of 4-week intervention period
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zehra Buyuktuncer, Prof. Dr., Hacettepe University
Publications and helpful links
General Publications
- Li L, Houghton D, Lietz G, Watson A, Stewart CJ, Bal W, Seal CJ. Impact of Daily Consumption of Whole-Grain Quinoa-Enriched Bread on Gut Microbiome in Males. Nutrients. 2022 Nov 18;14(22):4888. doi: 10.3390/nu14224888.
- Canaviri-Paz P, Oscarsson E, Kjellstrom A, Olsson H, Jois C, Hakansson A. Effects on Microbiota Composition after Consumption of Quinoa Beverage Fermented by a Novel Xylose-Metabolizing L. plantarum Strain. Nutrients. 2021 Sep 23;13(10):3318. doi: 10.3390/nu13103318.
- Neacsu M, Sayegh M, Vaughan NJ, Duncan GJ, Cantlay L, Anderson S, Henderson D, Fyfe C, Farquharson F, Saibu S, Horgan G, Louis P, Johnstone AM, Russell WR. Fava bean and buckwheat are sustainable food sources which support satiety and beneficially modulate several biomarkers, bacteria and metabolites associated with human health. Eur J Nutr. 2025 Jun 7;64(5):211. doi: 10.1007/s00394-025-03726-6.
- Espada MV, De la Cruz CR, Jeri C, Garcia-Tejedor A, Laparra JM. Chenopodium Quinoa's Ingredients Contribute to the Gut Microbiota's Metabolic Adaptations on Carbohydrate Metabolism. Plant Foods Hum Nutr. 2024 Dec 21;80(1):18. doi: 10.1007/s11130-024-01253-z.
- Li L, Lietz G, Bal W, Watson A, Morfey B, Seal C. Effects of Quinoa (Chenopodium quinoa Willd.) Consumption on Markers of CVD Risk. Nutrients. 2018 Jun 16;10(6):777. doi: 10.3390/nu10060777.
- Navarro-Perez D, Radcliffe J, Tierney A, Jois M. Quinoa Seed Lowers Serum Triglycerides in Overweight and Obese Subjects: A Dose-Response Randomized Controlled Clinical Trial. Curr Dev Nutr. 2017 Aug 24;1(9):e001321. doi: 10.3945/cdn.117.001321. eCollection 2017 Sep.
- De Carvalho FG, Ovidio PP, Padovan GJ, Jordao Junior AA, Marchini JS, Navarro AM. Metabolic parameters of postmenopausal women after quinoa or corn flakes intake--a prospective and double-blind study. Int J Food Sci Nutr. 2014 May;65(3):380-5. doi: 10.3109/09637486.2013.866637. Epub 2013 Dec 17.
- Marak NR, Das P, Das Purkayastha M, Baruah LD. Effect of quinoa (Chenopodium quinoa W.) flour supplementation in breads on the lipid profile and glycemic index: an in vivo study. Front Nutr. 2024 Mar 26;11:1341539. doi: 10.3389/fnut.2024.1341539. eCollection 2024.
- Pourshahidi LK, Caballero E, Osses A, Hyland BW, Ternan NG, Gill CIR. Modest improvement in CVD risk markers in older adults following quinoa (Chenopodium quinoa Willd.) consumption: a randomized-controlled crossover study with a novel food product. Eur J Nutr. 2020 Oct;59(7):3313-3323. doi: 10.1007/s00394-019-02169-0. Epub 2020 Jan 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-19102
- 20780 (Other Grant/Funding Number: Hacettepe University Scientific Research Committee Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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