Quinoa Effects on Glycemic Index and Satiety

Study Overview
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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.

Official Title
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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

Intervention / Treatment
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* Dietary Supplement: Quinoa variety 1
* Dietary Supplement: Quinoa variety 2
* Dietary Supplement: Quinoa variety 3
* Dietary Supplement: Quinoa variety 4
* Dietary Supplement: Anhydrous Glucose


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quinoa variety 1<br>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<br>* 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.<br>|
| Experimental: Quinoa variety 2<br>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<br>* 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.<br>|
| Experimental: Quinoa variety 3<br>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<br>* 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.<br>|
| Experimental: Quinoa variety 4<br>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<br>* 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.<br>|
| Active Comparator: Anhydrous Glucose<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quinoa, Satiety, Visual analogue scale, Cross-over studies