Healthy Properties of Two Almond Varieties. CEA vs. CARMEL

NCT03844867 | Completed

• 1 other identifier: 5037
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  3 days

Study Arms (1)

Filippo Cea and Carmel

EXPERIMENTAL

Subjects \<65 years.

Dietary Supplement: Filippo Cea and Carmel

Interventions

Filippo Cea and Carmel DIETARY_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).

Filippo Cea and Carmel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers.
• Aged 18-80 years old.
• Normal and obese subjects.
• Able to provide informed consent.

You may not qualify if:

• Refusal to sign the informed consent.
• Diagnosis of organic diseases including neoplastic inflammatory illness or cardiovascular diseases.
• Hypersensibility to almonds.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"

Bari, BA, 70124, Italy

Location

Related Publications (3)

• 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.

  PMID: 16187015 BACKGROUND

• Wu 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.

  PMID: 15186133 BACKGROUND

• Jenkins 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.

  PMID: 12221048 BACKGROUND

Study Officials

• Piero Portincasa, MD, PhD

  Department of Biomedical Sciences and Human Oncology - Clinica Medica "A. Murri"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 19, 2019
• Study Start: February 9, 2017
• Primary Completion: September 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

IT (1)