Clinical trial NCT02621502: Quinoa Effects on Glycemic Index and Satiety
Official title: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Quinoa
Satiety
Visual analogue scale
Cross-over studies
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Alicorp S.A.A.
First posted: 2015-12-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic index
timeFrame: 0, 15, 30, 45, 60, 90, 120 min
Secondary outcomes:
measure: Glucose metabolism related parameters
timeFrame: day 1, 8, 15, 22, 29
measure: satiety hunger assessment (visual analogue scale)
timeFrame: just before taking the product, just after taking the product, 30, 60 , 90, 120, 180, 240 min and 260 min after taking the product)
measure: Weight
timeFrame: day 1, 8, 15, 22, 29
measure: Adverse effects
timeFrame: day 1, 8, 15, 22, 29
measure: Blood hormonal markers
timeFrame: just before taking the product, 15, 30, 45, 60, 90 and 120 min after consuming the product
measure: height
timeFrame: day 1, 8, 15, 22, 29
measure: waist circumference
timeFrame: day 1, 8, 15, 22, 29
measure: BMI
timeFrame: day 1, 8, 15, 22, 29
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitairo La Paz
Study officials:
affiliation: La Paz University Hospital
name: Carmen Gómez Candela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: