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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Quinoa and quinoa-based food
Sponsored by
Institut d'Investigacions Biomèdiques August Pi i Sunyer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring quinoa, diabetes, nutrition, prevention

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Diana A. Díaz Rizzolo

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Regular diet

Quinoa diet

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Weight in kilograms
Subjects were weighed without clothing and shoes.
Height in meters
Subjects were measured without clothing and shoes.
Body mass index (BMI)
BMI was calculated as weight (kg)/height (m)²
Circumferences in cm
waist circumference was measured at the midpoint between the last rib and the iliac crest and hip circumference at the widest point of the gluteus
Blood pressure
Blood pressure was taken after individuals sat quietly for 5 min in a clinical examination room. The mean of three different measurements, obtained every 3 min using an OMRON M6 AC sphygmomanometer, was recorded.
Insulin levels (mU/L)
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Glucose homeostasis (mg/dl)
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Glycated hemoglobin HbA1c (%)
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Nutrient intake recorded
Nutritional patterns were measured using a 14-days dietary record revised corrected by a nutritionist and analyzed by the DIAL nutritional calculation program.

Full Information

First Posted
August 17, 2020
Last Updated
August 25, 2020
Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
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1. Study Identification

Unique Protocol Identification Number
NCT04529317
Brief Title
Beneficial Effects of Quinoa (Chenopodium Quinoa Willd) in the Prevention of Type 2 Diabetes Mellitus
Official Title
Beneficial Effects of Quinoa (Chenopodium Quinoa Willd) in the Prevention of Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer

4. Oversight

5. Study Description

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.
Detailed Description
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). A total of six visits plus two quinoa products collection days were programmed. After the pre-study visit (V0) which took place a week before start nutritional intervention and where researchers obtained signed informed consent, participants were summoned for a first visit (V1) where they were explained how they should fill in the dietary records and they were applied with the FreeStyle Libre®. Subjects then began RD, a period of 4 weeks during which only their normal life was monitored. After the first 14 days of this, a second visit (V2) was made where the dietary record was collected that would serve to account for their usual consumption of cereals, flours, tubers and legumes, the FreeStyle Libre® sensor was also collected. The last day on RD period, on day 28, they were cited (V3) in consultation where blood samples after an 8 hours fast, anthropometrics measurements and blood pressure measure where obtained and for the placement of the new FreeStyle Libre® sensor. Participants were asked about their physical activity and exercise practice during those past 4 weeks by a short questionnaire adapted from the Minnesota Leisure Time Physical Activity Questionnaire for individuals of advanced age (VREM questionnaire) and a new empty 14-day dietary record was given. In addition, the volunteers received the first foods with quinoa to initiate QD the next day. Products were delivered weekly, for conservation reasons but also to ensure that they followed an adequate consumption, they had to go through consultation to pick up the product and gave the researchers the empty packs where quinoa products had been. On the next visit the day 42 (V4) the Freestyle Libre® sensor was collected and the filled dietary record was collected. Finally, after 28 days of quinoa diet they were summoned for the last visit the day 56 (V5) where all the determinations were repeated identically as V3. With the premise that the products created replaced not only grains, legumes or tubers, but also farinaceous commonly consumed by the participants and that only the cereal fraction was modified, similar products based on quinoa flour were created. The creation of these products was necessary, after conducting a market search where it was observed that there was not enough food to replace those consumed since these had percentages of quinoa flour not exceeding 20-30%. 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 RD dietary records. Thus, only if the volunteer had indicated that he consumed sponge cake was the quinoa-based product delivered to him. Descriptive data are presented as the mean and standard deviation (SD) or median and interquartile range (IQR) for continuous variables, and the frequencies and percentages (%) for categorical variables. Anthropometric measurements, blood test variables and dietary intake were compared at different times using the non-parametric Wilcoxon signed rank test because normality and equality of variance could not be assumed due to small sample size (n=9). In order to compare variables related to dietary patterns, mean value for dietary intake, including all meals, was considered for each participant. The glucose level monitoring sensor takes measurements at discrete time points for each patient. Therefore, firstly the glucose curves have been linearly interpolated in order to have observations for each patient at equal time points. A first sight to the glucose curves over the day shown that they were more homogeneous around breakfast than around other later meals intakes. Therefore, the glucose concentration values corresponding to the breakfast were considered as a function of time in minutes over the interval t= [-30,120], that begins half an hour before the start of breakfast and ends two hours later. Before constructing a functional model, the functional data were time aligned in order to reduce the differences between different patients and/or different days (for instance, some patients could mark the starting time of breakfast systematically before than others, or spend systematically more time in breakfast than the average). The time alignment has been done by warping functions, using the function WFDA in the R package fdapace. Once the glucose level curves have been synchronized, a functional regression analysis was conducted to model the effect of diet type, patient and nutrient intake on monitored glucose levels. Three different explanatory variables have been considered: diet type with two categories (regular and Quinoa diets), patient indicator (categorical variable with nine levels) and the contents in different nutrients. The breakfast glucose curves are handled as the functional response variable. To study the relationship between these variables function on scalar regression (fosr) models were used. Firstly, the univariate effect of the diet type on glucose curves have been analyzed and then more complex fosr models with two factors (diet and patient factors) and scalar variables (nutrients) have been constructed. The most complex model including all effects of the independent variables is defined by a specific-created equation. The functional regression models have been fitted by penalized flexible functional regression, as implemented in the function pffr of the R package refund.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
quinoa, diabetes, nutrition, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular diet
Arm Type
No Intervention
Arm Description
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.
Arm Title
Quinoa diet
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Quinoa and quinoa-based food
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood glucose fluctuations
Description
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.
Time Frame
Comparing data obtained during 2 hours per day along 14 days both during regular diet and quinoa diet
Secondary Outcome Measure Information:
Title
Weight in kilograms
Description
Subjects were weighed without clothing and shoes.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Height in meters
Description
Subjects were measured without clothing and shoes.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Body mass index (BMI)
Description
BMI was calculated as weight (kg)/height (m)²
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Circumferences in cm
Description
waist circumference was measured at the midpoint between the last rib and the iliac crest and hip circumference at the widest point of the gluteus
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Blood pressure
Description
Blood pressure was taken after individuals sat quietly for 5 min in a clinical examination room. The mean of three different measurements, obtained every 3 min using an OMRON M6 AC sphygmomanometer, was recorded.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Insulin levels (mU/L)
Description
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Glucose homeostasis (mg/dl)
Description
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Glycated hemoglobin HbA1c (%)
Description
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Nutrient intake recorded
Description
Nutritional patterns were measured using a 14-days dietary record revised corrected by a nutritionist and analyzed by the DIAL nutritional calculation program.
Time Frame
Data obtained during 28 days quinoa diet compared to data obtained during 28 days regular diet
Other Pre-specified Outcome Measures:
Title
Hs-CRP (high-sensitivity C-reactive protein) in mg/L
Description
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
HDL (high-density lipoprotein) in mg/dL
Description
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
LDL (low-density lipoprotein) in mg/dL
Description
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Total cholesterol in mg/dL
Description
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Triglycerides in mg/dL
Description
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet
Title
Serum albumin in g/dL
Description
Fasting blood samples were collected by a nurse and they were analyzed by the Biomedical Diagnosis Centre (CDB) in Hospital Clinic de Barcelona.
Time Frame
Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Glucose levels between 100 and 125 mg/dL and without a previous diagnosis of diabetes Exclusion Criteria: 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.
Facility Information:
Facility Name
Diana A. Díaz Rizzolo
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

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

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