Quinoa Effects on Glycemic Index and Satiety

NCT ID: NCT02621502

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this study is to to assess the glycemic index and the satiating properties of different Quinoa varieties, using a Visual Analogue Scale in a sample of healthy overweight subjects.

Detailed Description

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Pilot study to evaluate the glycemic index, and the satiating effect using different Quinoa varieties in a group of healthy overweight subjects.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Quinoa variety 1

1 dose of Quinoa Variety 1 orally. The product is provided in a mix-pack together with water (100mL). This flexible container is capable of maintaining separate purified water (100 mL) and the experimental powder product in the same package. Both products can be easily mixed by breaking the inner seal. Volunteers had a maximum of 10 minutes to consume the product.

Group Type EXPERIMENTAL

Quinoa variety 1

Intervention Type DIETARY_SUPPLEMENT

On the intervention day, the volunteers will consume the Quinoa Variety 1.

Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:

* In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
* In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.

Quinoa variety 2

1 dose of Quinoa Variety 2 orally. The product is provided in a mix-pack together with water (100mL). This flexible container is capable of maintaining separate purified water (100 mL) and the experimental powder product in the same package. Both products can be easily mixed by breaking the inner seal. Volunteers had a maximum of 10 minutes to consume the product.

Group Type EXPERIMENTAL

Quinoa variety 2

Intervention Type DIETARY_SUPPLEMENT

On the intervention day, the volunteers will consume the Quinoa Variety 2.

Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:

* In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
* In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.

Quinoa variety 3

1 dose of Quinoa Variety 3 orally. The product is provided in a mix-pack together with water (100mL). This flexible container is capable of maintaining separate purified water (100 mL) and the experimental powder product in the same package. Both products can be easily mixed by breaking the inner seal. Volunteers had a maximum of 10 minutes to consume the product.

Group Type EXPERIMENTAL

Quinoa variety 3

Intervention Type DIETARY_SUPPLEMENT

On the intervention day, the volunteers will consume the Quinoa Variety 3.

Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:

* In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
* In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.

Quinoa variety 4

1 dose of Quinoa Variety 4 orally. The product is provided in a mix-pack together with water (100mL). This flexible container is capable of maintaining separate purified water (100 mL) and the experimental powder product in the same package. Both products can be easily mixed by breaking the inner seal. Volunteers had a maximum of 10 minutes to consume the product.

Group Type EXPERIMENTAL

Quinoa variety 4

Intervention Type DIETARY_SUPPLEMENT

On the intervention day, the volunteers will consume the Quinoa Variety 4.

Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:

* In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
* In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.

Anhydrous Glucose

1 dose of Anhydrous Glucose orally. . The product is provided in a mix-pack together with water (100mL). This flexible container is capable of maintaining separate purified water (100 mL) and the control powder product in the same package. Both products can be easily mixed by breaking the inner seal. Volunteers had a maximum of 10 minutes to consume the product.

Group Type ACTIVE_COMPARATOR

Anhydrous Glucose

Intervention Type DIETARY_SUPPLEMENT

On the intervention day, the volunteers will consume the control product.

Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:

* In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
* In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.

Interventions

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Quinoa variety 1

On the intervention day, the volunteers will consume the Quinoa Variety 1.

Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:

* In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
* In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.

Intervention Type DIETARY_SUPPLEMENT

Quinoa variety 2

On the intervention day, the volunteers will consume the Quinoa Variety 2.

Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:

* In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
* In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.

Intervention Type DIETARY_SUPPLEMENT

Quinoa variety 3

On the intervention day, the volunteers will consume the Quinoa Variety 3.

Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:

* In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
* In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.

Intervention Type DIETARY_SUPPLEMENT

Quinoa variety 4

On the intervention day, the volunteers will consume the Quinoa Variety 4.

Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:

* In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
* In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.

Intervention Type DIETARY_SUPPLEMENT

Anhydrous Glucose

On the intervention day, the volunteers will consume the control product.

Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:

* In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
* In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Men and women from 18 to 65 years old.
* Body mass index (BMI) ≥25 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent

Exclusion Criteria

* Individuals with BMI ≥30 or \<25 kg/m2
* Vegetarians or individuals with a fiber intake ≥30 g/day
* Individuals diagnosed with Diabetes Mellitus
* Individuals with dyslipidemia on pharmacological treatment
* Individuals with hypertension on pharmacological treatment
* Smokers or heavy drinking individuals (\>2-3 servings/day in men and \> 1 serving/day in women (1 serving=1 glass of wine or 1 bottle of beer))
* Individuals with large weight fluctuations or who have undergone in recent months a weight loss diet
* Individuals with gastrointestinal diseases that affect the digestion or the absorption of nutrients
* Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, oral antidiabetic medications)
* Pregnant or breastfeeding women
* Women with menstrual irregularities (absence of menstrual cycle at least 2 months prior)
* Individuals with intense physical activity
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alicorp S.A.A.

INDUSTRY

Sponsor Role collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Gómez Candela, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

La Paz University Hospital

Locations

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Hospital Universitairo La Paz

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Related Links

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http://www.idipaz.es/

La Paz University Hospital Research Institute

Other Identifiers

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QUINOA

Identifier Type: -

Identifier Source: org_study_id