ObesityCHECKMATENCT01851304
Metabolic Effect of New Foods Through Gut-brain Axis
A study testing Satiety of breads and Satiety of puddings in people with Obesity and Overweight, run by Federico II University at 1 site in Italy.
Trial summary
A diet high in easily obtained energy-dense foods leads to the problems of overweight and obesity common in the developed world. Foods enriched with fiber or bitter compounds may increase satiety and decrease energy intake. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Satiety of breads and Satiety of puddings
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Aug 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal body weight: Body Mass Index between 20 - 30
- Healthy by medical assessment
- Signed a written informed consent form
- Habitually consumes breakfast
Who cannot join
- Pregnant or breast feeding
- Diagnosed with intestinal or metabolic diseases/disorders, such as diabetes, renal, hepatic or pancreatic disorders, or ulcers
- Has hypertension or high cholesterol
- Food allergies and food intolerances including celiac disease and lactose intolerance
- Previous abdominal or gastrointestinal surgery
- Regular consumption of medication or drugs (including cannabis)
Show all 9Show fewer
- Antibiotic or prebiotic therapy within the previous 2 months of the study
- Unwillingness to consume experimental foods
- Concurrent participation or previous participation in another clinical trial during the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Checking Melanoidins and Bitter Compound Satiating Efficiency Through Evaluation of Human Gut-brain Response to Novel-food Ingestion
A diet high in easily obtained energy-dense foods leads to the problems of overweight and obesity common in the developed world. Foods enriched with fiber or bitter compounds may increase satiety and decrease energy intake. This intervention will measure the effectiveness of coffee melanoidins, bread melanoidins, beta-glucans, and a Gentiana lutea L. extract in both a free or encapsulated form to decrease energy intake and modify the physiological markers of satiety in the short term. In particular bread (fiber) and a pudding (Gentiana lutea L. extract) will be used as tasty food matrices in the study.
Read the detailed description
Overweight and obesity are health problems of utmost importance to the world population. The continuous development and consumption of high-energy foods at a low cost is correlated with an increased risk of diabetes and insulin resistance in addition to weight gain. To maintain body weight, a balance between energy intake and energy expenditure must be obtained. Since weight gain is a common outcome with an energy-dense diet, the best approach to reduce caloric intake is through the consumption of fruits and vegetables. However, this approach is usually unsatisfactory in the long-term as the loss of tasty food and the low reward of healthy meals often undermines the nutritionally prudent diet. A possible alternative approach is to produce tasty foods with low caloric density and satiety-inducing compounds that can reduce caloric intake and increase the sensation of satiety.
The human body regulates energy intake through a complex and interconnected biological system involving gut-brain axis, the endocannabinoid system and the hypothalamic-pituitary-adrenal axis. Biomarkers in the hypothalamic-pituitary-adrenal axis regulate food intake and the physiological response to stress. In the absence of food, the brain senses hunger through the elevation of the gastrointestinal hormone ghrelin. Once food is ingested, ghrelin levels decrease while other biomarkers in the gut-brain axis are released to increase feelings of satiety through the delay of gastric emptying, decrease in appetite and the decrease in food intake. Recent studies in mice have linked the endocannabinoid system with the hypothalamic-pituitary-adrenal axis through physiological stress and energy homeostasis. Furthermore, the endocannabinoids anandamide and 2-arachidonoylglycerol are both elevated during hunger but decrease after feeding.
Natural foods with low energy density, such as fruits and vegetables, usually contain a high amount of dietary fiber. Dietary fiber is classified as either soluble fiber (beta-glucans) or insoluble fiber (wheat bran) but both soluble and insoluble fiber have been strongly linked to increased satiety sensation. Dietary fiber is important for a properly functioning gastrointestinal tract by providing a nutrient source for bacteria in the large intestine. When a 3% portion of barley beta-glucans were added to a fruit drink or to bread and consumed at breakfast, a reduction in energy intake of 30% over 24 hours was observed along with beneficial changes in post-prandial gastrointestinal hormones involved in the biological control of hunger and satiety. Intake of insoluble fiber improves insulin sensitivity and enriched barley fiber bread or wheat fiber bread improved ghrelin and peptide YY (PYY) hormone response compared to control bread. A recently characterized class of food compounds, melanoidins, have been found to exhibit similar properties to dietary fiber in the gastrointestinal tract. Melanoidins are formed by the Maillard reaction process through the reaction of proteins with reduced carbohydrates and sugars during the cooking of heat-treated foods. Melanoidins are large insoluble or partially insoluble complexes that are present in coffee, bread, cocoa, and beer. However, the main sources of melanoidins in the diet are from coffee and bread with a contribution of 0.5-2.0 g/day of coffee melanoidins and 1.8-15 g/day of bread melanoidins. Research has shown that coffee melanoidins are fermented in the gastrointestinal tract while bread melanoidins stimulate bifidobacteria in the large intestine.
Bitter compounds have also been recently implicated in increasing satiety and having a beneficial effect on gastrointestinal tract hormones. Recent research in animals indicates that several bitter compounds can reduce the rate of gastric emptying, induce the secretion of satiety-inducing hormones cholecystokinin and glucagon-like peptide 1 (GLP-1), and decrease food intake. However, the animal experiments required the bitter compounds to be delivered directly to the stomach for action. A few bitter tasting vegetables, including broccoli and chicory, show beneficial health effects. Some natural phytochemicals are polyphenols known to possess different biological mechanisms and to have a bitter taste. The plant species Gentiana lutea L. produces several biologically active bitter phytochemicals, including the iridoid (loganic acid) and the secoiridoids (swertiamarin, gentiopicroside, amarogentin, sweroside). Gentiana lutea L. is used most often for the production of herbal teas and liqueurs.
In this randomized, crossover trial, the hunger and satiety feelings will be measured while blood will be collected at specific time points during the seven arms. Since this intervention is to develop tasty foods that both increase satiety and decrease energy intake in the short term, the bitter compounds will also be encapsulated in a protective coating. Encapsulation is commonly used to protect pharmaceuticals during passage through the oral cavity or stomach to enable the active compounds to be properly absorbed in the body. The coating used in one arm will allow the Gentiana lutea L. extract to pass through the oral cavity, allowing the volunteers to not taste the bitter compounds, for target in the stomach and duodenum.
All volunteers will participate in the seven arms of the study. Three different fiber-enriched breads and a control bread will be consumed in addition to skim milk at breakfast in four interventions. In the other three interventions, participants will consume a control pudding, Gentiana lutea L. extract pudding and the encapsulated Gentiana lutea L. extract pudding. A one-week washout period will be included between two separate interventions. The hedonic feelings of satiety, hunger, and appetite will be measured with a questionnaire at time 0 (baseline) and at 0.5, 1, 2, and 3 hours after breakfast. After 3 hours, the volunteers will consume lunch until they are satiated and then keep a food diary to record their intake throughout the rest of the day. In addition, blood will be collected at each time point and the amount of the specific hormones, neuropeptides, and endocannabinoids will be measured as part of the secondary outcomes.
- Conditions
- Obesity, Overweight
- Being tested
- Satiety of breads, Satiety of puddings
- Keywords
- beta-Glucans, Bitter, Bread, Coffee, Gentiana lutea, Melanoidins, Microencapsulation
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satiety of breadsDietary supplement
One separate breakfast session to consume each bread along with 125 mL skim milk. The session will start after an overnight fast followed by 5 separate blood draws over a 3 hour period before a provided lunch.
Satiety of puddingsDietary supplement
One separate breakfast session will be used to evaluate satiating efficacy of puddings after an overnight fast. After pudding consumption, five separate blood draws will be taken over a 3 hour period before a provided lunch.
| Study group | Role | What they receive |
|---|---|---|
| Control Bread | Placebo comparator | A 100 g portion of Control Bread with no extra fiber added. The control bread will be consumed in the intervention Satiety of breads Receives: Dietary Supplement: Satiety of breads |
| Bread Crust Bread | Experimental | A 100 g portion of Bread Crust Bread with 3 g bread crust per 100 g portion of control bread. The bread crust bread will be consumed in the intervention Satiety of breads. Receives: Dietary Supplement: Satiety of breads |
| Coffee Melanoidins Bread | Experimental | A 100 g portion of Coffee Melanoidins Bread with 3 g of isolated coffee melanoidins per 100 g portion of control bread. The coffee melanoidins bread will be consumed in the intervention Satiety of breads. Receives: Dietary Supplement: Satiety of breads |
| beta-Glucans Bread | Experimental | A 100 g portion of beta-Glucans Bread with 3 g of barley beta-glucans per 100 g portion of control bread. The beta-glucans bread will be consumed in the intervention Satiety of breads. Receives: Dietary Supplement: Satiety of breads |
| Control Pudding | Placebo comparator | A 150 g portion of Control Pudding without the addition of any extracts. The control pudding will be consumed in the intervention Satiety of puddings. Receives: Dietary Supplement: Satiety of puddings |
| Gentian extract pudding | Experimental | A 150 g portion of Gentian Pudding with the addition of 1 g Gentian extract per 100 g pudding. The Gentian extract pudding will be consumed in the intervention Satiety of puddings. Receives: Dietary Supplement: Satiety of puddings |
| Encapsulated Gentian Extract Pudding | Experimental | A 150 g portion of Microencapsulated Gentian extract pudding with the addition of 1 g of a microencapsulated Gentian extract per 100 g pudding. The Microencapsulated Gentian extract pudding will be consumed in the intervention Satiety of puddings. Receives: Dietary Supplement: Satiety of puddings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in the feelings of appetite
Measure of the satiating effect for each bread and pudding with Visual Analog Scale (Area Under the Curve) over time for hunger, fullness and satiety.
Measured: 0, 0.5, 1, 2, and 3 hours
Secondary outcomes (6)
Variation in neuropeptide markers
Measure serum beta-endorphin, neurotensin, orexin A, substance P, oxytocin, melatonin, alpha-melanocyte-stimulating hormone (pg/mL) and area under the curve (AUC) over time.
Measured: 0, 0.5, 1, 2, 3 hours
Variation in stress markers
Measure serum cortisol (pg/mL) and area under the curve (AUC) over time.
Measured: 0, 0.5, 1, 2, 3 hours
Variation in serum endocannabinoids
Measure serum anandamide, oleoylethanolamide, palmitoylethanolamide, linoleoyl ethanolamide (pg/mL) and area under the curve (AUC) over time.
Measured: 0, 0.5, 1, 2, 3 hours
Variation in salivary enzyme activity
Measure salivary lipase (U/L) and salivary alpha-amylase (U/mL) activity.
Measured: 0, 0.5, 1, 2, 3 hours
Variation in salivary endocannabinoids
Measure salivary anandamide, oleoylethanolamide, palmitoylethanolamide, linoleoyl ethanolamide (pg/mL)
Measured: 0, 0.5, 1, 2, 3 hours
Variation in gastrointestinal markers
Measure serum ghrelin, peptide YY, glucagon-like peptide 1 (GLP-1), pancreatic polypeptide (PP), amylin, gastric inhibitory polypeptide (GIP), leptin, insulin (pg/mL)and area under the curve (AUC) over time.
Measured: 0, 0.5, 1, 2, 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Federico II 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Vitaglione, Federico II University
- Investigators
- Paola Vitaglione, Dr, Study director, University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851304
- Sponsor's protocol ID
- CKMPON-013
- Acronym
- CHECKMATE
- Status last verified
- Sep 2015
- First submitted
- 8 May 2013
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Checking Melanoidins and Bitter Compound Satiating Efficiency Through Evaluation of Human Gut-brain Response to Novel-food Ingestion
- ClinicalTrials.gov ID
- NCT01851304
- Acronym / sponsor ID
- CHECKMATE / CKMPON-013
- Conditions
- Obesity, Overweight
- Keywords
- beta-Glucans, Bitter, Bread, Coffee, Gentiana lutea, Melanoidins, Microencapsulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 May 2013 (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.
A diet high in easily obtained energy-dense foods leads to the problems of overweight and obesity common in the developed world. Foods enriched with fiber or bitter compounds may increase satiety and decrease energy intake. This intervention will measure the effectiveness of coffee melanoidins, bread melanoidins, beta-glucans, and a Gentiana lutea L. extract in both a free or encapsulated form to decrease energy intake and modify the physiological markers of satiety in the short term. In particular bread (fiber) and a pudding (Gentiana lutea L. extract) will be used as tasty food matrices in the study.
Detailed description
Overweight and obesity are health problems of utmost importance to the world population. The continuous development and consumption of high-energy foods at a low cost is correlated with an increased risk of diabetes and insulin resistance in addition to weight gain. To maintain body weight, a balance between energy intake and energy expenditure must be obtained. Since weight gain is a common outcome with an energy-dense diet, the best approach to reduce caloric intake is through the consumption of fruits and vegetables. However, this approach is usually unsatisfactory in the long-term as the loss of tasty food and the low reward of healthy meals often undermines the nutritionally prudent diet. A possible alternative approach is to produce tasty foods with low caloric density and satiety-inducing compounds that can reduce caloric intake and increase the sensation of satiety.
The human body regulates energy intake through a complex and interconnected biological system involving gut-brain axis, the endocannabinoid system and the hypothalamic-pituitary-adrenal axis. Biomarkers in the hypothalamic-pituitary-adrenal axis regulate food intake and the physiological response to stress. In the absence of food, the brain senses hunger through the elevation of the gastrointestinal hormone ghrelin. Once food is ingested, ghrelin levels decrease while other biomarkers in the gut-brain axis are released to increase feelings of satiety through the delay of gastric emptying, decrease in appetite and the decrease in food intake. Recent studies in mice have linked the endocannabinoid system with the hypothalamic-pituitary-adrenal axis through physiological stress and energy homeostasis. Furthermore, the endocannabinoids anandamide and 2-arachidonoylglycerol are both elevated during hunger but decrease after feeding.
Natural foods with low energy density, such as fruits and vegetables, usually contain a high amount of dietary fiber. Dietary fiber is classified as either soluble fiber (beta-glucans) or insoluble fiber (wheat bran) but both soluble and insoluble fiber have been strongly linked to increased satiety sensation. Dietary fiber is important for a properly functioning gastrointestinal tract by providing a nutrient source for bacteria in the large intestine. When a 3% portion of barley beta-glucans were added to a fruit drink or to bread and consumed at breakfast, a reduction in energy intake of 30% over 24 hours was observed along with beneficial changes in post-prandial gastrointestinal hormones involved in the biological control of hunger and satiety. Intake of insoluble fiber improves insulin sensitivity and enriched barley fiber bread or wheat fiber bread improved ghrelin and peptide YY (PYY) hormone response compared to control bread. A recently characterized class of food compounds, melanoidins, have been found to exhibit similar properties to dietary fiber in the gastrointestinal tract. Melanoidins are formed by the Maillard reaction process through the reaction of proteins with reduced carbohydrates and sugars during the cooking of heat-treated foods. Melanoidins are large insoluble or partially insoluble complexes that are present in coffee, bread, cocoa, and beer. However, the main sources of melanoidins in the diet are from coffee and bread with a contribution of 0.5-2.0 g/day of coffee melanoidins and 1.8-15 g/day of bread melanoidins. Research has shown that coffee melanoidins are fermented in the gastrointestinal tract while bread melanoidins stimulate bifidobacteria in the large intestine.
Bitter compounds have also been recently implicated in increasing satiety and having a beneficial effect on gastrointestinal tract hormones. Recent research in animals indicates that several bitter compounds can reduce the rate of gastric emptying, induce the secretion of satiety-inducing hormones cholecystokinin and glucagon-like peptide 1 (GLP-1), and decrease food intake. However, the animal experiments required the bitter compounds to be delivered directly to the stomach for action. A few bitter tasting vegetables, including broccoli and chicory, show beneficial health effects. Some natural phytochemicals are polyphenols known to possess different biological mechanisms and to have a bitter taste. The plant species Gentiana lutea L. produces several biologically active bitter phytochemicals, including the iridoid (loganic acid) and the secoiridoids (swertiamarin, gentiopicroside, amarogentin, sweroside). Gentiana lutea L. is used most often for the production of herbal teas and liqueurs.
In this randomized, crossover trial, the hunger and satiety feelings will be measured while blood will be collected at specific time points during the seven arms. Since this intervention is to develop tasty foods that both increase satiety and decrease energy intake in the short term, the bitter compounds will also be encapsulated in a protective coating. Encapsulation is commonly used to protect pharmaceuticals during passage through the oral cavity or stomach to enable the active compounds to be properly absorbed in the body. The coating used in one arm will allow the Gentiana lutea L. extract to pass through the oral cavity, allowing the volunteers to not taste the bitter compounds, for target in the stomach and duodenum.
All volunteers will participate in the seven arms of the study. Three different fiber-enriched breads and a control bread will be consumed in addition to skim milk at breakfast in four interventions. In the other three interventions, participants will consume a control pudding, Gentiana lutea L. extract pudding and the encapsulated Gentiana lutea L. extract pudding. A one-week washout period will be included between two separate interventions. The hedonic feelings of satiety, hunger, and appetite will be measured with a questionnaire at time 0 (baseline) and at 0.5, 1, 2, and 3 hours after breakfast. After 3 hours, the volunteers will consume lunch until they are satiated and then keep a food diary to record their intake throughout the rest of the day. In addition, blood will be collected at each time point and the amount of the specific hormones, neuropeptides, and endocannabinoids will be measured as part of the secondary outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control Bread | Placebo comparator | Dietary Supplement: Satiety of breadsA 100 g portion of Control Bread with no extra fiber added. The control bread will be consumed in the intervention Satiety of breads |
| Bread Crust Bread | Experimental | Dietary Supplement: Satiety of breadsA 100 g portion of Bread Crust Bread with 3 g bread crust per 100 g portion of control bread. The bread crust bread will be consumed in the intervention Satiety of breads. |
| Coffee Melanoidins Bread | Experimental | Dietary Supplement: Satiety of breadsA 100 g portion of Coffee Melanoidins Bread with 3 g of isolated coffee melanoidins per 100 g portion of control bread. The coffee melanoidins bread will be consumed in the intervention Satiety of breads. |
| beta-Glucans Bread | Experimental | Dietary Supplement: Satiety of breadsA 100 g portion of beta-Glucans Bread with 3 g of barley beta-glucans per 100 g portion of control bread. The beta-glucans bread will be consumed in the intervention Satiety of breads. |
| Control Pudding | Placebo comparator | Dietary Supplement: Satiety of puddingsA 150 g portion of Control Pudding without the addition of any extracts. The control pudding will be consumed in the intervention Satiety of puddings. |
| Gentian extract pudding | Experimental | Dietary Supplement: Satiety of puddingsA 150 g portion of Gentian Pudding with the addition of 1 g Gentian extract per 100 g pudding. The Gentian extract pudding will be consumed in the intervention Satiety of puddings. |
| Encapsulated Gentian Extract Pudding | Experimental | Dietary Supplement: Satiety of puddingsA 150 g portion of Microencapsulated Gentian extract pudding with the addition of 1 g of a microencapsulated Gentian extract per 100 g pudding. The Microencapsulated Gentian extract pudding will be consumed in the intervention Satiety of puddings. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal body weight: Body Mass Index between 20 - 30
- Healthy by medical assessment
- Signed a written informed consent form
- Habitually consumes breakfast
Key exclusion criteria (9 listed)
- Pregnant or breast feeding
- Diagnosed with intestinal or metabolic diseases/disorders, such as diabetes, renal, hepatic or pancreatic disorders, or ulcers
- Has hypertension or high cholesterol
- Food allergies and food intolerances including celiac disease and lactose intolerance
- Previous abdominal or gastrointestinal surgery
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 |
|---|---|---|
| Satiety of breadsOne separate breakfast session to consume each bread along with 125 mL skim milk. The session will start after an overnight fast followed by 5 separate blood draws over a 3 hour period before a provided lunch. | Dietary supplement | Bread Crust Bread, Coffee Melanoidins Bread, Control Bread, beta-Glucans Bread |
| Satiety of puddingsOne separate breakfast session will be used to evaluate satiating efficacy of puddings after an overnight fast. After pudding consumption, five separate blood draws will be taken over a 3 hour period before a provided lunch. | Dietary supplement | Control Pudding, Encapsulated Gentian Extract Pudding, Gentian extract pudding |
Primary outcome
Variation in the feelings of appetite
Time frame: 0, 0.5, 1, 2, and 3 hours
Measure of the satiating effect for each bread and pudding with Visual Analog Scale (Area Under the Curve) over time for hunger, fullness and satiety.
6 secondary outcomes
Variation in neuropeptide markers
Time frame: 0, 0.5, 1, 2, 3 hours
Variation in stress markers
Time frame: 0, 0.5, 1, 2, 3 hours
Variation in serum endocannabinoids
Time frame: 0, 0.5, 1, 2, 3 hours
Variation in salivary enzyme activity
Time frame: 0, 0.5, 1, 2, 3 hours
Variation in salivary endocannabinoids
Time frame: 0, 0.5, 1, 2, 3 hours
Variation in gastrointestinal markers
Time frame: 0, 0.5, 1, 2, 3 hours
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 2 Oct 2015.
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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.
Paola Vitaglione, Dr study director
University of Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Satiety of breads and Satiety of puddings in people with Obesity and Overweight, run by Federico II University at 1 site in Italy.
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 9 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 2 Oct 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 Italy. 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?
Variation in the feelings of appetite (time frame: 0, 0.5, 1, 2, and 3 hours). 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 2 Oct 2015.