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Completed

NCT Number: NCT02621502

Quinoa Effects on Glycemic Index and Satiety

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitairo La Paz

Madrid, 28046, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quinoa variety 1

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Glycemic index

    Time frame: 0, 15, 30, 45, 60, 90, 120 min

    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

Secondary outcomes

  1. Glucose metabolism related parameters

    Time frame: day 1, 8, 15, 22, 29

    glucose and insulin assessed in 7 point curves

  2. satiety hunger assessment (visual analogue scale)

    Time frame: just before taking the product, just after taking the product, 30, 60 , 90, 120, 180, 240 min and 260 min after taking the product)

    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

  3. Weight

    Time frame: day 1, 8, 15, 22, 29

    Weight

  4. Adverse effects

    Time frame: day 1, 8, 15, 22, 29

    symptoms of gastrointestinal intolerance (nausea, diarrhea, bloating or other gastrointestinal disorder

  5. Blood hormonal markers

    Time frame: just before taking the product, 15, 30, 45, 60, 90 and 120 min after consuming the product

    ghrelin, GLP-1 (glucagon-like peptide) and peptide YY

  6. height

    Time frame: day 1, 8, 15, 22, 29

  7. waist circumference

    Time frame: day 1, 8, 15, 22, 29

  8. BMI

    Time frame: day 1, 8, 15, 22, 29

    body mass index

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

  • Alicorp S.A.A.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 3, 2015
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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