OverweightNCT02621502
Quinoa Effects on Glycemic Index and Satiety
A study testing Quinoa variety 1, Quinoa variety 2 and Quinoa variety 3 in people with Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Quinoa variety 1, Quinoa variety 2 and Quinoa variety 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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))
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate the Glycemic Index, and the Satiating Effect Using Different Quinoa Varieties in a Group of Healthy Overweight Subjects
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.
Read the detailed description
Pilot study to evaluate the glycemic index, and the satiating effect using different Quinoa varieties in a group of healthy overweight subjects.
- Conditions
- Overweight
- Being tested
- Quinoa variety 1, Quinoa variety 2, Quinoa variety 3, Quinoa variety 4, Anhydrous Glucose
- Keywords
- Quinoa, Satiety, Visual analogue scale, Cross-over studies
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinoa variety 1Dietary 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 2Dietary 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 3Dietary 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 4Dietary 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 GlucoseDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Quinoa variety 1 | Experimental | 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. Receives: Dietary Supplement: Quinoa variety 1 |
| Quinoa variety 2 | Experimental | 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. Receives: Dietary Supplement: Quinoa variety 2 |
| Quinoa variety 3 | Experimental | 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. Receives: Dietary Supplement: Quinoa variety 3 |
| Quinoa variety 4 | Experimental | 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. Receives: Dietary Supplement: Quinoa variety 4 |
| Anhydrous Glucose | Active comparator | 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. Receives: Dietary Supplement: Anhydrous Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0, 15, 30, 45, 60, 90, 120 min
Secondary outcomes (8)
Glucose metabolism related parameters
glucose and insulin assessed in 7 point curves
Measured: 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
Measured: 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
Measured: day 1, 8, 15, 22, 29
Adverse effects
symptoms of gastrointestinal intolerance (nausea, diarrhea, bloating or other gastrointestinal disorder
Measured: day 1, 8, 15, 22, 29
Blood hormonal markers
ghrelin, GLP-1 (glucagon-like peptide) and peptide YY
Measured: just before taking the product, 15, 30, 45, 60, 90 and 120 min after consuming the product
height
Measured: day 1, 8, 15, 22, 29
waist circumference
Measured: day 1, 8, 15, 22, 29
BMI
body mass index
Measured: day 1, 8, 15, 22, 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Alicorp S.A.A.
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, MD, PhD, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621502
- Sponsor's protocol ID
- QUINOA
- Status last verified
- Dec 2015
- First submitted
- 18 Nov 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Glycemic Index, and the Satiating Effect Using Different Quinoa Varieties in a Group of Healthy Overweight Subjects
- ClinicalTrials.gov ID
- NCT02621502
- Acronym / sponsor ID
- QUINOA
- Conditions
- Overweight
- Keywords
- Quinoa, Satiety, Visual analogue scale, Cross-over studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Alicorp S.A.A.
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Quinoa variety 1 | Experimental | Dietary Supplement: Quinoa variety 11 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 | Experimental | Dietary Supplement: Quinoa variety 21 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 | Experimental | Dietary Supplement: Quinoa variety 31 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 | Experimental | Dietary Supplement: Quinoa variety 41 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 comparator | Dietary Supplement: Anhydrous Glucose1 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quinoa variety 1On 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. | Dietary supplement | Quinoa variety 1 |
| Quinoa variety 2On 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. | Dietary supplement | Quinoa variety 2 |
| Quinoa variety 3On 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. | Dietary supplement | Quinoa variety 3 |
| Quinoa variety 4On 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. | Dietary supplement | Quinoa variety 4 |
| Anhydrous GlucoseOn 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. | Dietary supplement | Anhydrous Glucose |
Primary outcome
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
8 secondary outcomes
Glucose metabolism related parameters
Time frame: day 1, 8, 15, 22, 29
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)
Weight
Time frame: day 1, 8, 15, 22, 29
Adverse effects
Time frame: day 1, 8, 15, 22, 29
Blood hormonal markers
Time frame: just before taking the product, 15, 30, 45, 60, 90 and 120 min after consuming the product
height
Time frame: day 1, 8, 15, 22, 29
waist circumference
Time frame: day 1, 8, 15, 22, 29
BMI
Time frame: day 1, 8, 15, 22, 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- La Paz University Hospital Research InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gómez Candela, MD, PhD principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quinoa variety 1, Quinoa variety 2 and Quinoa variety 3 in people with Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic index (time frame: 0, 15, 30, 45, 60, 90, 120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.