Quinoa Effects on Glycemic Index and Satiety

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621502
• Other study ID #: QUINOA
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: December 1, 2015
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Overweight

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitairo La Paz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Alicorp S.A.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Glucose metabolism related parameters	glucose and insulin assessed in 7 point curves	day 1, 8, 15, 22, 29	Yes
Secondary	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)	Yes
Secondary	Weight	Weight	day 1, 8, 15, 22, 29	Yes
Secondary	Adverse effects	symptoms of gastrointestinal intolerance (nausea, diarrhea, bloating or other gastrointestinal disorder	day 1, 8, 15, 22, 29	Yes
Secondary	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	Yes
Secondary	height		day 1, 8, 15, 22, 29	Yes
Secondary	waist circumference		day 1, 8, 15, 22, 29	Yes
Secondary	BMI	body mass index	day 1, 8, 15, 22, 29	Yes

External Links

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