Adjuvant Treatment in Elderly Patients With Periodontitis Through the Administration of a Supplement Rich in Oleuropein From the Olive Leaf

NCT05482373 | Unknown

• 1 other identifier: PI-001-2020
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Life expectancy has dramatically increased in the last century, although this process has not been always accompanied by an equivalent increase in healthy life expectancy. However, extending longevity without decreasing the risk of age-associated pathologies would not be desirable since non-communicable diseases can diminish seniors' quality of life, raise health-care costs, and increase pressure on family members who are responsible for their care. Maintaining a good health would help to ensure independence, security, and continued productivity in the later years helping both health systems and pensions lower costs. Thus, many scientific studies have tried to delay the age of onset of major age-related chronic diseases. In other words, research has been more focused on extending healthspan rather than lifespan. Actually, numerous experimental studies have shown that the extension of lifespan by modifying risk factors is usually accompanied by delayed or reduced morbidity, including cardiovascular disease, neurodegeneration, and tumors. In the dietary context, modifications of the diet energy and/or macronutrient balance has shown to contribute to healthy aging, increasing healthspan and probably lifespan. Likewise, some foods would be able to supply a significant amount of compounds to the human diet, including non-nutrients which are thought to exert effects in the same sense. Thus, adequate nutritional intervention would be considered geroprotective interventions that would positively influence health by slowing basic biological processes of aging, such as cellular senescence, mitochondrial dysfunction, age-related decline of stress resistance, dysregulated cellular energy sensing/growth pathways, impaired proteostasis, deteriorated stem cell function/bioavailability, as well as inflammation/oxidative stress. The use of nutraceuticals and functional foods from olive products and by-products can be useful in the treatment of pathologies associated with aging, such as periodontitis, as well as from the point of view of a proper nutrition during aging. The study is a double-blind clinical trial of parallel design whose main objective is to evaluate the usefulness of a dietary supplement rich in oleuropein from the olive tree (leaf) in the adjuvant treatment of patients with age-related periodontitis. Efforts will be made to ensure that men and women be represented homogeneously in all study groups, although it is known that gender does not influence the appearance of periodontitis. The experimental design foresees the inclusion of 130 patients with chronic periodontitis aged 60 years or older, 65 for the control group and 65 for the treatment group. Volunteers will be recruited from new patients attending the Faculty of Odontology at the University of Sevilla, Sevilla (Spain) by one study team member. The investigational product will be provided by Natac Company (Madrid, Spain), a corporate group dedicated to researching, developing, manufacturing, and marketing natural ingredients to be used in food supplements, feed, pet food, as well as in functional foods, and as natural, active pharmaceutical ingredients. The planned schedule for the participating subjects is as follows:

• Day 0: diagnosis of periodontitis, proposal to participate in the study, delivery of consent and information to the patient.
• Day 15: oral exams, collection of sociodemographic data, study of anthropometric characteristics and blood pressure, evaluation of eating habits, urine and blood sampling, collection of samples for the study of the periodontal microbiota and data collection and calculation of the index of successful ageing.
• Day 16 to 30 periodontal treatment.
• Day 16 to 136: administration of treatment (oleuropein or placebo).
• Day 136: oral exams, collection of sociodemographic data, study of anthropometric characteristics and blood pressure, evaluation of eating habits, urine and blood sampling, collection of samples for the study of the periodontal microbiota and data collection and calculation of the index of successful ageing. The analytical part of the of the clinical trial will be developed mostly in the Biomedical Research Center (CIBM) of the University of Granada. The field part of the clinical trial in patients with periodontitis will be carried out at the Faculty of Dentistry of the University of Seville. The design of the clinical trial provides for the participation of specialists from several disciplines, including specialists in Nutrition and Physiology, clinical specialists in Pathological Anatomy and Dentistry, technicians from the Center of Scientific Instrumentation of the University of Granada (specialists in various subjects such as microscopy, biochemical analysis, histology and veterinary) as well as technicians from the Marketing Unit of the OTRI of the University of Granada.

Conditions

Periodontitis

Keywords

Aging; Periodontitis; Nutraceuticals; Oleuropein; Olive tree; Adjuvant

Outcome Measures

Primary Outcomes (1)

• Probing depth

  Change of 2 mm or more

  120 days

Secondary Outcomes (2)

• Attachment level

  120 days

• Gum bleeding

  120 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients will receive hard gelatin capsules containing placebo (only the excipients).

Dietary Supplement: Placebo

Oleuropein

EXPERIMENTAL

Patients will receive the same hard gelatin capsules but containing 200 mg of an olive leaf extract.

Dietary Supplement: Oleuropein from olive tree

Interventions

Oleuropein from olive tree DIETARY_SUPPLEMENT

The capsules intake will last for a total of 4 months.

Oleuropein

Placebo DIETARY_SUPPLEMENT

The capsules intake will last for a total of 4 months.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with periodontitis, defined as interdental attachment loss in ≥2 non-adjacent teeth or lingual or buccal attachment loss ≥3 mm in ≥2 teeth.

You may not qualify if:

• Patients taking antimicrobial drugs in the previous 6 months or anti-inflammatory drugs during the previous 2 months,
• Patients taking regular vitamin supplementation,
• Patients receiving treatment for any periodontal condition,
• Patients with any autoimmune disease,
• Patients with any disease affecting oral mucosa,
• Patients with any systemic disease affecting bone metabolism,
• Patients with aggressive disease,
• Patients with physical or mental disability or unable to provide informed consent,
• Patients unable to swallow capsules,
• Patients at risk of complications from periodontal therapy.

Sponsors & Collaborators

• Jose Luis Quiles Morales: lead

Study Sites (1)

Jose Luis Quiles Morales

Granada, 18100, Spain

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: April 15, 2021
• Primary Completion: February 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)