Glucose ToleranceNCT04439630
Effects of Nopal Fractions on Postprandial Glucose Regulation and Appetite Variables in Healthy Humans
A study testing Nopal fractions and Test product without the active components in people with Glucose Tolerance and Appetite Sensations, run by Lund University at 1 site in Sweden.
Trial summary
Postprandial effects of Nopal fractions on glucose and appetite regulation will be investigated in healthy humans, in a randomised controlled crossover trial Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Tolerance, Appetite Sensations
- What is being tested?
- Nopal fractions and Test product without the active components
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2020to 1 Aug 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- non-smokers
- diet accordance with the Nordic Nutrition Recommendations
- BMI: 18.5-25 kg/m2
Who cannot join
- metabolic disorders
- food allergies
- no probiotics or other food /supplement which may interfere with the study
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 Regard to Their Effects on Cardiometabolic Test Markers and Cognitive Variables
Postprandial effects of Nopal fractions on glucose and appetite regulation will be investigated in healthy humans, in a randomised controlled crossover trial
- Conditions
- Glucose Tolerance, Appetite Sensations
- Being tested
- Nopal fractions, Test product without the active components
- Keywords
- healthy subjects, diabetes prevention, obesity prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nopal fractionsDietary supplement
Nopal flour were divided in two fractions and mixed in two different test breads
Test product without the active componentsDietary supplement
Test product without the active components
| Study group | Role | What they receive |
|---|---|---|
| reference | Sham comparator | Test product without the active components Receives: Dietary Supplement: Test product without the active components |
| Nopal fraction 1 | Experimental | Fraction one out of two possible Receives: Dietary Supplement: Nopal fractions |
| Nopal fraction 2 | Experimental | Fraction two out of two possible Receives: Dietary Supplement: Nopal fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial glucose tolerance
effects on postprandial glucose tolerance after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
Measured: 0-180 min after start of the meal
postprandial insulin concentrations
effects on serum insulin concentrations after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
Measured: 0-180 min
Secondary outcomes (1)
subjective appetite variables
Subjective appetite variables (hunger, satiety, desire to eat) after intake of test products at breakfast, using a 100 mm Visual Analogue Scale (VAS) on a white paper. Except from a center mark in the center of the scale there was no other visible marks. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
Measured: 0-180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose ToleranceStudies 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
- Model description
- randomised crossover study in healthy young adults with normal BMI
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Nilsson, Lund University
- Investigators
- Anne Nilsson, assoc. prof., Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439630
- Sponsor's protocol ID
- Protokoll 2018/8-b
- Status last verified
- Oct 2020
- First submitted
- 18 Jun 2020
- Last updated
- 5 Oct 2020
- Results posted
- 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 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potentially Bioactive Foods With Regard to Their Effects on Cardiometabolic Test Markers and Cognitive Variables
- ClinicalTrials.gov ID
- NCT04439630
- Acronym / sponsor ID
- Protokoll 2018/8-b
- Conditions
- Glucose Tolerance, Appetite Sensations
- Keywords
- healthy subjects, diabetes prevention, obesity prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 19 Jun 2020 (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.
Postprandial effects of Nopal fractions on glucose and appetite regulation will be investigated in healthy humans, in a randomised controlled crossover trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomised crossover study in healthy young adults with normal BMI
| Arm | Type | Receives |
|---|---|---|
| reference | Sham comparator | Dietary Supplement: Test product without the active componentsTest product without the active components |
| Nopal fraction 1 | Experimental | Dietary Supplement: Nopal fractionsFraction one out of two possible |
| Nopal fraction 2 | Experimental | Dietary Supplement: Nopal fractionsFraction two out of two possible |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- non-smokers
- diet accordance with the Nordic Nutrition Recommendations
- BMI: 18.5-25 kg/m2
Key exclusion criteria (3 listed)
- metabolic disorders
- food allergies
- no probiotics or other food /supplement which may interfere with the study
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 fractionsNopal flour were divided in two fractions and mixed in two different test breads | Dietary supplement | Nopal fraction 1, Nopal fraction 2 |
| Test product without the active componentsTest product without the active components | Dietary supplement | reference |
Primary outcome
postprandial glucose tolerance
Time frame: 0-180 min after start of the meal
effects on postprandial glucose tolerance after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
postprandial insulin concentrations
Time frame: 0-180 min
effects on serum insulin concentrations after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
1 secondary outcome
subjective appetite variables
Time frame: 0-180 min
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 5 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Glucose Tolerance
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Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
Not yet recruiting
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
Postprandial Glucose, GI Tolerance
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.
Anne Nilsson, assoc. prof. principal investigator
Lund University
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 fractions and Test product without the active components in people with Glucose Tolerance and Appetite Sensations, 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 4 inclusion and 3 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 5 Oct 2020. 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?
postprandial glucose tolerance (time frame: 0-180 min after start of the meal). The study lists 2 primary outcomes in all. 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 5 Oct 2020.