Quinoa Effects on Glycemic Index and Satiety

Pilot Study to Evaluate the Glycemic Index, and the Satiating Effect Using Different Quinoa Varieties in a Group of Healthy Overweight Subjects

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: Quinoa variety 1; Dietary supplement: Quinoa variety 2; Dietary supplement: Quinoa variety 3; Dietary supplement: Quinoa variety 4; Dietary supplement: Anhydrous Glucose

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Hospital Universitairo La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic index	The glycemic index is calculated with the incremental area under the curve of the glycemic response 7 time points ( 0 , 15 , 30, 45 , 60, 90 , 120 min) to 50 g intake carbohydrate food test food and reference	0, 15, 30, 45, 60, 90, 120 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose metabolism related parameters	glucose and insulin assessed in 7 point curves	day 1, 8, 15, 22, 29
satiety hunger assessment (visual analogue scale)	visual analogue scale to assessment satiety and hunger will be picked up in 9 time points to calculate the area under the curve to get a score	just before taking the product, just after taking the product, 30, 60 , 90, 120, 180, 240 min and 260 min after taking the product)
Weight	Weight	day 1, 8, 15, 22, 29
Adverse effects	symptoms of gastrointestinal intolerance (nausea, diarrhea, bloating or other gastrointestinal disorder	day 1, 8, 15, 22, 29
Blood hormonal markers	ghrelin, GLP-1 (glucagon-like peptide) and peptide YY	just before taking the product, 15, 30, 45, 60, 90 and 120 min after consuming the product
height		day 1, 8, 15, 22, 29
waist circumference		day 1, 8, 15, 22, 29
BMI	body mass index	day 1, 8, 15, 22, 29

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Alicorp S.A.A.

Publications and helpful links

Helpful Links

• Research group in Nutrition and Functional Foods (NUTRINVEST)
• La Paz University Hospital Research Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Satiety; Visual analogue scale; Quinoa; Cross-over studies
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: QUINOA