Beneficial Effects of Quinoa (Chenopodium Quinoa Willd) in the Prevention of Type 2 Diabetes Mellitus

NCT04529317 | Completed

• 1 other identifier: Quinoa
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Quinoa is a pseudo-cereal and has potential health benefits and exceptional nutritional value. It is a food rich in proteins of high biological value, in unsaturated fats and fiber, it is also a grain low in carbohydrates and with a low glycemic index. Concretely, quinoa could produce a benefit on postprandial glycemia that would result in lower type 2 diabetes (T2D) incidence. A cross-over design pilot clinical study with a nutritional intervention for 8 weeks were performed: 4 weeks on a regular diet (RD) and 4 weeks on a quinoa diet (QD). Nine subjects aged ≥65 years with prediabetes were monitored during the first 4 weeks of RD with daily dietary records and FreeStyle Libre®. Subsequently, participants started the DQ where quinoa and 100% quinoa-based products replaced foods rich in complex carbohydrates that they regularly consumed by the first 4 weeks of DR. The glycemic measurements recorded by the sensors were considered as functions of time and the effects of nutrients consumed at the intended time period were analyzed by means of function on scalar regression (fosr) model.

Conditions

Type 2 Diabetes

Keywords

quinoa; diabetes; nutrition; prevention

Outcome Measures

Primary Outcomes (1)

• Blood glucose fluctuations

  Glucose fluctuations were measured by FreeStyle Libre® Flash Glucose Monitoring System (Abbott Laboratories) which measures interstitial fluid glucose concentrations. The sensor was applied by researchers on to the back of the upper arm of subjects using the applicator and participants were trained to obtain electronically all the glucose records concentrations every 15 minutes so they had to scan at least once every eight hours. The glucose level monitoring sensor takes measurements at discrete time points for each patient Therefore, firstly the glucose curves have been linearly interpolated and has been considered as a function of time in minutes over interval. Then, a functional model analyses were constructed as described in "study protocol and statistical analyses" document attached.

  Comparing data obtained during 2 hours per day along 14 days both during regular diet and quinoa diet

Secondary Outcomes (9)

• Weight in kilograms

  Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet

• Height in meters

  Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet

• Body mass index (BMI)

  Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet

• Circumferences in cm

  Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet

• Blood pressure

  Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet

Other Outcomes (6)

• Hs-CRP (high-sensitivity C-reactive protein) in mg/L

  Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet

• HDL (high-density lipoprotein) in mg/dL

  Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet

• LDL (low-density lipoprotein) in mg/dL

  Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet

Study Arms (2)

Regular diet

NO INTERVENTION

The study was a cross-over pilot clinical study consisting of two periods. The first period was only an observational and monitoring phase where participants just continued with their regular diet (RD), for this reason all participants initiated this period and wash-out term was no needed.

Quinoa diet

EXPERIMENTAL

With the data of the first phase obtained, the subjects began the second period in which they had to undergo a nutritional intervention with a quinoa diet (QD).

Dietary Supplement: Quinoa and quinoa-based food

Interventions

Quinoa and quinoa-based food DIETARY_SUPPLEMENT

Products created replaced grains, legumes, tubers, also farinaceous commonly consumed by the participants and only the cereal fraction was modified, similar products based on quinoa flour were created. Thus, apart from delivering quinoa, quinoa flakes and quinoa flour to the participants, they were given products created with ≥70% quinoa flour and were biscuits, crackers, brioche, sponge cake, baguette bread, sliced bread and pasta. Moreover, a quinoa-based recipe was delivered with eight commonly consumed recipes that replaced the tuber, legume or grain of the recipe. Each subject received the equivalent of what they consumed according to their regular diet dietary records.

Quinoa diet

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Glucose levels between 100 and 125 mg/dL and without a previous diagnosis of diabetes

You may not qualify if:

• Do not consume a diet with daily presence of grains or cereals derivatives, tubers or/and legumes, or they presented any other health problem that the research staff considered contraindicated:
• Treatment with oral antidiabetic drugs Chronic treatment with oral steroids and / or AINES Treatment with oral antidiabetic agents and / or insulin Treatment with immunosuppressive drugs Diagnosis of active neoplasm Diagnosis of HIV or AIDS Abnormal liver profile (\> 6 times normal values) Diagnosis of Acute Psychiatric Sdr Presence of serious acute concomitant disease, which it requires more than 7 days of recovery.
• Major cardiovascular event (stroke, myocardial infarction) in the month prior to randomization.
• Any other condition that the investigator considers to be inoperative so that the subject conducts the study.

Sponsors & Collaborators

• Institut d'Investigacions Biomèdiques August Pi i Sunyer: lead

Study Sites (1)

Diana A. Díaz Rizzolo

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RD, Clinical Professor.

Model Details: The study was a cross-over pilot clinical study consisting of two periods. The first period was only an observational and monitoring phase where participants just continued with their regular diet (RD), for this reason all participants initiated this period and wash-out term was no needed. Subsequently, with the data of the first phase obtained, the subjects began the second period in which they had to undergo a nutritional intervention with a quinoa diet (QD).

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 27, 2020
• Study Start: May 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

ES (1)