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
1 other identifier
interventional
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
December 3, 2015
CompletedDecember 3, 2015
December 1, 2015
3 months
November 18, 2015
December 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Glucose metabolism related parameters
day 1, 8, 15, 22, 29
satiety hunger assessment (visual analogue scale)
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
day 1, 8, 15, 22, 29
Adverse effects
day 1, 8, 15, 22, 29
Blood hormonal markers
just before taking the product, 15, 30, 45, 60, 90 and 120 min after consuming the product
- +3 more secondary outcomes
Study Arms (5)
Quinoa variety 1
EXPERIMENTAL1 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.
Quinoa variety 2
EXPERIMENTAL1 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.
Quinoa variety 3
EXPERIMENTAL1 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.
Quinoa variety 4
EXPERIMENTAL1 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.
Anhydrous Glucose
ACTIVE COMPARATOR1 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.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitairo La Paz
Madrid, Madrid, 28046, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen Gómez Candela, MD, PhD
La Paz University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2015
First Posted
December 3, 2015
Study Start
September 1, 2014
Primary Completion
December 1, 2014
Study Completion
January 1, 2015
Last Updated
December 3, 2015
Record last verified: 2015-12