Healthy SubjectsALMOND1NCT03844867
Healthy Properties of Two Almond Varieties. CEA vs. CARMEL
A study testing Filippo Cea and Carmel in people with Healthy Subjects, run by University of Bari at 1 site in Italy.
Trial summary
The cultivation of almond (Amygdalus communis L.) has always been a hallmark of the Mediterranean, representing a resource both food and economic. Almonds are high in fat (55.3%, mainly (39.4%) they consist of MUFA), are an excellent source of vitamin E, manganese, magnesium, copper, phosphorus, fiber, riboflavin and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Filippo Cea and Carmel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 9 Feb 2017to 1 Jan 2018
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers.
- Aged 18-80 years old.
- Normal and obese subjects.
- Able to provide informed consent.
Who cannot join
- Refusal to sign the informed consent.
- Diagnosis of organic diseases including neoplastic inflammatory illness or cardiovascular diseases.
- Hypersensibility to almonds.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"
Bari, BA, 70124
About this study
Official title: ALMOND1: Nutritional, Organoleptic and Motility Profile of Toritto & Californian Almond
The cultivation of almond (Amygdalus communis L.) has always been a hallmark of the Mediterranean, representing a resource both food and economic. Almonds are high in fat (55.3%, mainly (39.4%) they consist of MUFA), are an excellent source of vitamin E, manganese, magnesium, copper, phosphorus, fiber, riboflavin and protein, phenolic and polyphenolic.
Numerous studies correlate moderate and regular consumption of nuts with an important role in health. In particular, habitual almond consumption does not lead to weight gain, and their inclusion in low-calorie diets appears to promote more weight loss than a comparable carbohydrate-based low-calorie diet. Also, almonds have a low glycemic index and do not adversely impact insulin sensitivity. So they reduce certain risk factors linked to diabetes and cardiovascular disease. Almonds are an excellent source of bioavailable α-tocopherol, and increasing their intake enhances the resistance of LDL against oxidation. In addition, the polyphenolic constituents of almonds have been characterized recently and found to possess antioxidant actions. Some studies show as consumption of almonds has been shown to be associated with lower levels of serum cholesterol and triglycerides thanks of their poly-unsaturated fatty acids.
Read more
Despite Mediterranean countries have dominated world trade for a long time, from the '80 years, Italy underwent a strong production crisis, mainly due to the lack of new plants conducted according to the most modern techniques of cultivation and competition from other crops considered more profitable (e.g. wine, horticultural and citrus). The United States, in particular California, currently control more than a third of the world production of almond, using different cultivars and agronomic practices, based on more modern systems.
In Apulia, various native cultivars have been developed such as "Filippo Cea", which have resisted the invasion of the most productive varieties of California.
The aim of the project is to assess the quality and the beneficial effects of almonds, comparing a local cultivar (Filippo Cea) with an imported (Carmel) one. The study will be characterized by different phases:
- Organoleptic analysis of the two different cultivars of almonds
- evaluation of gastrointestinal motility after taking the two types of almonds.
Read the detailed description
The cultivation of almond (Amygdalus communis L.) has always been a hallmark of the Mediterranean, representing a resource both food and economic. To traditional uses, mostly related the confectionery industry, they are added other in cosmetics.
The plant is perfectly adapted to the Mediterranean climate, characterized by hot, dry summers, and is often associated to olive, carob and fig trees, species with similar climatic requirements. Almonds are a nutrient-dense food. They are high in fat (55.3%), mainly (39.4%) they consist of monounsaturated fatty acids (MUFA). Moreover, almonds are an excellent source of vitamin E, manganese, magnesium, copper, phosphorus, fibre, riboflavin and protein. In addition, almond proteins are unusually high in arginine and possess good digestibility. Recent studies have shown that almonds also contain a diverse array of phenolic and polyphenolic.
Numerous studies correlate the moderate and regular consumption of nuts with an important role in health. In particular, habitual almond consumption does not lead to weight gain, and their inclusion in low-calorie diets appears to promote more weight loss than a comparable carbohydrate-based low-calorie diet. Also, almonds have a low glycemic index and do not adversely impact insulin sensitivity. So they reduce certain risk factors linked to diabetes and cardiovascular disease. Almonds are an excellent source of bioavailable α-tocopherol, and increasing their intake enhances the resistance of LDL against oxidation. In addition, the polyphenolic constituents of almonds have been characterized recently and found to possess antioxidant actions. Some studies show as consumption of almonds has been shown to be associated with lower levels of serum cholesterol and triglycerides thanks of their polyunsaturated fatty acids.
They are also indicated in the diet of elderly people by helping to increase bone mineral density. Important is also the antibacterial and antifungal power of almond oils shown in recent years.
Despite Mediterranean countries (particularly Spain and Italy) have dominated world trade for a long time, from the '80 years, Italy underwent a strong production crisis, mainly due to the lack of new plants conducted according to the most modern techniques of cultivation and competition from other crops considered more profitable (eg. wine, horticultural and citrus). The United States currently control more than a third of the world production of almond, using different cultivars and agronomic practices, based on more modern systems. Californian industry is characterized by much larger companies than Italian and modern mechanized harvesting systems linked to the condition of serious shortage of manpower. This allowed it to create a standardized product with no impurities, selected and beautifully packaged who conquered large segments of trade, while not offering a high standard from the point of view of the qualitative composition.
In Apulia, almond of Toritto has spread on the border between pre-Murgia and Alta Murgia which takes its name from the country where it is produced. Here various native cultivars have been developed such as "Filippo Cea", the "Antonio De Vito" and "Genco", which have resisted the invasion of the most productive varieties of California. Almond of Toritto is a product of excellence, recognized as typical Apulian product, entered in the list of Italian traditional food products of the Ministry of Agriculture, Food and Forestry.
- Conditions
- Healthy Subjects
- Being tested
- Filippo Cea and Carmel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filippo Cea and CarmelDietary supplement
Subjects will be given a subjective organoleptic assessment of both the almonds (Filippo Cea and Carmel) administered blindly and randomly.
Motility test: Each subject will be subjected to gastrointestinal motility study according to international guidelines, i.e. he will be evaluated in 3 different days. The test will be made in response to test-meal ('NutriDrink') or Filippo Cea almonds (12 gr. fat=24 gr. almonds) or Carmel almonds (12 gr. fat = 24 gr. almonds).
| Study group | Role | What they receive |
|---|---|---|
| Filippo Cea and Carmel | Experimental | Subjects <65 years. Receives: Dietary Supplement: Filippo Cea and Carmel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organoleptic valuations
Subjects will give a subjective organoleptic assessment of both the almonds (Filippo Cea and Carmel) administered blindly and randomly. A semiquantitative scale (ranging from 0 to 3, in order of ascertainment for sensations, from lower=0 to higher=3 grade) will be used as markers of visual aspects, olfactory, flavor, mouth tactile sensations. Before each test, and also between the two samples, the mouth will be washed with mineral water. Food, drink, smoking and physical activity will not be allowed before and during the test.
Measured: 1 day
Visual Analog Scale
A quantitative visual analogue scale (VAS, ranging from 0 to 100 mm on a horizontal line, from lower to higher ascertainment for sensations) will be used as markers of visual aspects, olfactory, flavor, mouth tactile sensations.
Measured: 1 day
Ultrasound examination (gallbladder, stomach) and orocecal transit time)
Each subject will be subjected to gastrointestinal motility study according to international guidelines, i.e. he will be evaluated in 3 different days, in the morning in the fasting state to monitor gastric empting, gallbladder empting (ultrasound) and oro-cecal transit time (H 2 lactulose BT), at baseline and at 5 minutes intervals during the firsts 30 minutes, and at 15 minutes intervals during the remaining 90 minutes, for a total of 2 hours of observations. The test will be made in response to test-meal ('NutriDrink') or Filippo Cea almonds (12 gr. fat=24 gr. almonds) or Carmel almonds (12 gr. fat = 24 gr. almonds).
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start9 Feb 2017
- Primary completion1 Sep 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, piero portincasa, University of Bari
- Investigators
- Piero Portincasa, MD, PhD, Principal investigator, Department of Biomedical Sciences and Human Oncology - Clinica Medica "A. Murri"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844867
- Sponsor's protocol ID
- 5037
- Acronym
- ALMOND1
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ahrens S, Venkatachalam M, Mistry AM, Lapsley K, Sathe SK. Almond (Prunus dulcis L.) protein quality. Plant Foods Hum Nutr. 2005 Sep;60(3):123-8. doi: 10.1007/s11130-005-6840-2.
PubMed 16187015Wu X, Beecher GR, Holden JM, Haytowitz DB, Gebhardt SE, Prior RL. Lipophilic and hydrophilic antioxidant capacities of common foods in the United States. J Agric Food Chem. 2004 Jun 16;52(12):4026-37. doi: 10.1021/jf049696w.
PubMed 15186133Jenkins DJ, Kendall CW, Marchie A, Parker TL, Connelly PW, Qian W, Haight JS, Faulkner D, Vidgen E, Lapsley KG, Spiller GA. Dose response of almonds on coronary heart disease risk factors: blood lipids, oxidized low-density lipoproteins, lipoprotein(a), homocysteine, and pulmonary nitric oxide: a randomized, controlled, crossover trial. Circulation. 2002 Sep 10;106(11):1327-32. doi: 10.1161/01.cir.0000028421.91733.20.
PubMed 12221048
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALMOND1: Nutritional, Organoleptic and Motility Profile of Toritto & Californian Almond
- ClinicalTrials.gov ID
- NCT03844867
- Acronym / sponsor ID
- ALMOND1 / 5037
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 19 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 cultivation of almond (Amygdalus communis L.) has always been a hallmark of the Mediterranean, representing a resource both food and economic. Almonds are high in fat (55.3%, mainly (39.4%) they consist of MUFA), are an excellent source of vitamin E, manganese, magnesium, copper, phosphorus, fiber, riboflavin and protein, phenolic and polyphenolic.
Numerous studies correlate moderate and regular consumption of nuts with an important role in health. In particular, habitual almond consumption does not lead to weight gain, and their inclusion in low-calorie diets appears to promote more weight loss than a comparable carbohydrate-based low-calorie diet. Also, almonds have a low glycemic index and do not adversely impact insulin sensitivity. So they reduce certain risk factors linked to diabetes and cardiovascular disease. Almonds are an excellent source of bioavailable α-tocopherol, and increasing their intake enhances the resistance of LDL against oxidation. In addition, the polyphenolic constituents of almonds have been characterized recently and found to possess antioxidant actions. Some studies show as consumption of almonds has been shown to be associated with lower levels of serum cholesterol and triglycerides thanks of their poly-unsaturated fatty acids.
Despite Mediterranean countries have dominated world trade for a long time, from the '80 years, Italy underwent a strong production crisis, mainly due to the lack of new plants conducted according to the most modern techniques of cultivation and competition from other crops considered more profitable (e.g. wine, horticultural and citrus). The United States, in particular California, currently control more than a third of the world production of almond, using different cultivars and agronomic practices, based on more modern systems.
In Apulia, various native cultivars have been developed such as "Filippo Cea", which have resisted the invasion of the most productive varieties of California.
The aim of the project is to assess the quality and the beneficial effects of almonds, comparing a local cultivar (Filippo Cea) with an imported (Carmel) one. The study will be characterized by different phases:
- Organoleptic analysis of the two different cultivars of almonds
- evaluation of gastrointestinal motility after taking the two types of almonds.
Detailed description
The cultivation of almond (Amygdalus communis L.) has always been a hallmark of the Mediterranean, representing a resource both food and economic. To traditional uses, mostly related the confectionery industry, they are added other in cosmetics.
The plant is perfectly adapted to the Mediterranean climate, characterized by hot, dry summers, and is often associated to olive, carob and fig trees, species with similar climatic requirements. Almonds are a nutrient-dense food. They are high in fat (55.3%), mainly (39.4%) they consist of monounsaturated fatty acids (MUFA). Moreover, almonds are an excellent source of vitamin E, manganese, magnesium, copper, phosphorus, fibre, riboflavin and protein. In addition, almond proteins are unusually high in arginine and possess good digestibility. Recent studies have shown that almonds also contain a diverse array of phenolic and polyphenolic.
Numerous studies correlate the moderate and regular consumption of nuts with an important role in health. In particular, habitual almond consumption does not lead to weight gain, and their inclusion in low-calorie diets appears to promote more weight loss than a comparable carbohydrate-based low-calorie diet. Also, almonds have a low glycemic index and do not adversely impact insulin sensitivity. So they reduce certain risk factors linked to diabetes and cardiovascular disease. Almonds are an excellent source of bioavailable α-tocopherol, and increasing their intake enhances the resistance of LDL against oxidation. In addition, the polyphenolic constituents of almonds have been characterized recently and found to possess antioxidant actions. Some studies show as consumption of almonds has been shown to be associated with lower levels of serum cholesterol and triglycerides thanks of their polyunsaturated fatty acids.
They are also indicated in the diet of elderly people by helping to increase bone mineral density. Important is also the antibacterial and antifungal power of almond oils shown in recent years.
Despite Mediterranean countries (particularly Spain and Italy) have dominated world trade for a long time, from the '80 years, Italy underwent a strong production crisis, mainly due to the lack of new plants conducted according to the most modern techniques of cultivation and competition from other crops considered more profitable (eg. wine, horticultural and citrus). The United States currently control more than a third of the world production of almond, using different cultivars and agronomic practices, based on more modern systems. Californian industry is characterized by much larger companies than Italian and modern mechanized harvesting systems linked to the condition of serious shortage of manpower. This allowed it to create a standardized product with no impurities, selected and beautifully packaged who conquered large segments of trade, while not offering a high standard from the point of view of the qualitative composition.
In Apulia, almond of Toritto has spread on the border between pre-Murgia and Alta Murgia which takes its name from the country where it is produced. Here various native cultivars have been developed such as "Filippo Cea", the "Antonio De Vito" and "Genco", which have resisted the invasion of the most productive varieties of California. Almond of Toritto is a product of excellence, recognized as typical Apulian product, entered in the list of Italian traditional food products of the Ministry of Agriculture, Food and Forestry.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filippo Cea and Carmel | Experimental | Dietary Supplement: Filippo Cea and CarmelSubjects <65 years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers.
- Aged 18-80 years old.
- Normal and obese subjects.
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- Refusal to sign the informed consent.
- Diagnosis of organic diseases including neoplastic inflammatory illness or cardiovascular diseases.
- Hypersensibility to almonds.
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 |
|---|---|---|
| Filippo Cea and CarmelSubjects will be given a subjective organoleptic assessment of both the almonds (Filippo Cea and Carmel) administered blindly and randomly. Motility test: Each subject will be subjected to gastrointestinal motility study according to international guidelines, i.e. he will be evaluated in 3 different days. The test will be made in response to test-meal ('NutriDrink') or Filippo Cea almonds (12 gr. fat=24 gr. almonds) or Carmel almonds (12 gr. fat = 24 gr. almonds). | Dietary supplement | Filippo Cea and Carmel |
Primary outcome
Organoleptic valuations
Time frame: 1 day
Subjects will give a subjective organoleptic assessment of both the almonds (Filippo Cea and Carmel) administered blindly and randomly. A semiquantitative scale (ranging from 0 to 3, in order of ascertainment for sensations, from lower=0 to higher=3 grade) will be used as markers of visual aspects, olfactory, flavor, mouth tactile sensations. Before each test, and also between the two samples, the mouth will be washed with mineral water. Food, drink, smoking and physical activity will not be allowed before and during the test.
Visual Analog Scale
Time frame: 1 day
A quantitative visual analogue scale (VAS, ranging from 0 to 100 mm on a horizontal line, from lower to higher ascertainment for sensations) will be used as markers of visual aspects, olfactory, flavor, mouth tactile sensations.
Ultrasound examination (gallbladder, stomach) and orocecal transit time)
Time frame: 3 days
Each subject will be subjected to gastrointestinal motility study according to international guidelines, i.e. he will be evaluated in 3 different days, in the morning in the fasting state to monitor gastric empting, gallbladder empting (ultrasound) and oro-cecal transit time (H 2 lactulose BT), at baseline and at 5 minutes intervals during the firsts 30 minutes, and at 15 minutes intervals during the remaining 90 minutes, for a total of 2 hours of observations. The test will be made in response to test-meal ('NutriDrink') or Filippo Cea almonds (12 gr. fat=24 gr. almonds) or Carmel almonds (12 gr. fat = 24 gr. almonds).
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 19 Feb 2019.
- Background: PubMed 16187015Ahrens S, Venkatachalam M, Mistry AM, Lapsley K, Sathe SK. Almond (Prunus dulcis L.) protein quality. Plant Foods Hum Nutr. 2005 Sep;60(3):123-8. doi: 10.1007/s11130-005-6840-2.
- Background: PubMed 15186133Wu X, Beecher GR, Holden JM, Haytowitz DB, Gebhardt SE, Prior RL. Lipophilic and hydrophilic antioxidant capacities of common foods in the United States. J Agric Food Chem. 2004 Jun 16;52(12):4026-37. doi: 10.1021/jf049696w.
- Background: PubMed 12221048Jenkins DJ, Kendall CW, Marchie A, Parker TL, Connelly PW, Qian W, Haight JS, Faulkner D, Vidgen E, Lapsley KG, Spiller GA. Dose response of almonds on coronary heart disease risk factors: blood lipids, oxidized low-density lipoproteins, lipoprotein(a), homocysteine, and pulmonary nitric oxide: a randomized, controlled, crossover trial. Circulation. 2002 Sep 10;106(11):1327-32. doi: 10.1161/01.cir.0000028421.91733.20.
- Individual participant dataSharing planned: Undecided
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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.
Piero Portincasa, MD, PhD principal investigator
Department of Biomedical Sciences and Human Oncology - Clinica Medica "A. Murri"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filippo Cea and Carmel in people with Healthy Subjects, run by University of Bari 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 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 19 Feb 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 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. 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?
Organoleptic valuations (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844867, which also lists 3 linked publications.
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 19 Feb 2019.