HealthyNCT03831893
Metabolic Effects of Nopal in Healthy Humans
A study testing Nopal food product 1 and Nopal food product 2 in people with Healthy, run by Lund University at 1 site in Sweden.
Trial summary
The overall goal is to increase the knowledge that can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nopal food product 1 and Nopal food product 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- 29 Mar 2019to 13 Aug 2019
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women (non-smokers), BMI 18,5-30 kg/m2, and with no known metabolic disorders or food allergies will be recruited to the studies. The test subjects should consume a normal diet in accordance with the Nordic Nutrition Recommendations.
Who cannot join
- Fasting blood glucose >6.1 mmol/L. Metabolic diseases or conditions. Food allergies or gastro- intestinal conditions. Consumption of probiotics, antibiotics or other drugs..
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Food Technology, engineering and Nutrition, LTH, Lund University
Lund, 22100
About this study
Official title: Evaluation of Potentially Bioactive Foods With Respect to Effects on Metabolic Test Markers and Cognitive Variables
The overall goal is to increase the knowledge that can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the purpose of this study is to evaluate effects on metabolic test markers of Nopal (Opuntia) in healthy humans.
Read the detailed description
The study include three visits at the research unit. At two of the visits the test subjects consume nopal in different doses. At one visit the subjects will consume a reference product. The intervention products are consumed at breakfast (at 8.00) and metabolic effects are investigated 3 hours postprandially. Consumption of the intervention products is separated by a one week washout period.
- Conditions
- Healthy
- Being tested
- Nopal food product 1, Nopal food product 2, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nopal food product 1Other
Dried Nopal incorporated in a food product
Nopal food product 2Other
Dried Nopal incorporated in a food product
controlOther
Food Product without nopal
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | A food product similar to the test products but without nopal Receives: Other: control |
| Nopal food product 1 | Experimental | Food product with Nopal Receives: Other: Nopal food product 1 |
| Nopal food product 2 | Experimental | Food product with Nopal Receives: Other: Nopal food product 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose tolerance
Repeated blood glucose determinations in the postprandial period after breakfast. The area under the curve, using incremental changes from baseline, are used in the statistical evaluation to determine glucose tolerance.
Measured: 3 hours after breakfast (measurements at fasting, at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)
Secondary outcomes (2)
subjective appetite sensations
changes in subjective appetite sensations will be registered in the postprandial period at breakfast, using 0 - 100 mm visual analogue scales (VAS scale). The two end points of the scales (i.e. 0 mm and 100 mm) represent the minimum and maximum, respectively, agreement with a appetite sensation. The hunger sensations to measure are: hunger, satiety and desire to eat.The area under the curve are used in the statistical evaluation to determine
Measured: 3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)
Mood
Changes in mood parameters (valence and activity) will be registered in the postprandial period after breakfast.The mood measurements will be assessed using the Swedish Core Affect Scale which included three self-reporting rating scales for evaluating valence (unpleasantness-pleasantness) and for activation (quietness-excitement), respectively. The subjective mood ratings are registered using 0 mm-100 mm VAS. The two end points of the scales (i.e. 0 mm and 100 mm) represent the minimum and maximum, respectively, agreement with a sensation to be rated.The valence rating is assessed by obtaining a mean rating of three scales graded from displeased-pleased, sad-glad and depressed-happy, respectively, and the rating of activation is assessed by obtaining a mean rating of three scales graded from sleepy-awake, passive-active and dull-peppy, respectively.
Measured: 3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Mean values are calculated and used in the statistical evaluations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start29 Mar 2019
- Primary completion30 Jul 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Nilsson, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831893
- Sponsor's protocol ID
- 2019-00980
- Other IDs
- 2019
- Status last verified
- Oct 2019
- First submitted
- 4 Feb 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potentially Bioactive Foods With Respect to Effects on Metabolic Test Markers and Cognitive Variables
- ClinicalTrials.gov ID
- NCT03831893
- Acronym / sponsor ID
- 2019-00980
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 6 Feb 2019 (actual)
- 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 overall goal is to increase the knowledge that can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the purpose of this study is to evaluate effects on metabolic test markers of Nopal (Opuntia) in healthy humans.
Detailed description
The study include three visits at the research unit. At two of the visits the test subjects consume nopal in different doses. At one visit the subjects will consume a reference product. The intervention products are consumed at breakfast (at 8.00) and metabolic effects are investigated 3 hours postprandially. Consumption of the intervention products is separated by a one week washout period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: controlA food product similar to the test products but without nopal |
| Nopal food product 1 | Experimental | Other: Nopal food product 1Food product with Nopal |
| Nopal food product 2 | Experimental | Other: Nopal food product 2Food product with Nopal |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women (non-smokers), BMI 18,5-30 kg/m2, and with no known metabolic disorders or food allergies will be recruited to the studies. The test subjects should consume a normal diet in accordance with the Nordic Nutrition Recommendations.
Key exclusion criteria (1 listed)
- Fasting blood glucose >6.1 mmol/L. Metabolic diseases or conditions. Food allergies or gastro- intestinal conditions. Consumption of probiotics, antibiotics or other drugs..
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 |
|---|---|---|
| Nopal food product 1Dried Nopal incorporated in a food product | Other | Nopal food product 1 |
| Nopal food product 2Dried Nopal incorporated in a food product | Other | Nopal food product 2 |
| controlFood Product without nopal | Other | Control |
Primary outcome
Blood glucose tolerance
Time frame: 3 hours after breakfast (measurements at fasting, at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)
Repeated blood glucose determinations in the postprandial period after breakfast. The area under the curve, using incremental changes from baseline, are used in the statistical evaluation to determine glucose tolerance.
2 secondary outcomes
subjective appetite sensations
Time frame: 3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)
Mood
Time frame: 3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Mean values are calculated and used in the statistical evaluations)
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 21 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nopal food product 1 and Nopal food product 2 in people with Healthy, run by Lund University at 1 site in Sweden.
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 1 inclusion and 1 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 21 Oct 2019. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
Blood glucose tolerance (time frame: 3 hours after breakfast (measurements at fasting, at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)). 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 21 Oct 2019.