Effect of Black Raspberry Phytochemicals on Oral Microbiome in Current Smokers and Non-smokers
Ключови думи
Резюме
Описание
PRIMARY OBJECTIVES:
I. Determine the effect of black raspberry phytochemicals on community dynamics within oral biofilms.
II. Examine the effect of oral bacterial communities on metabolism of black raspberry phytochemicals in current and never smokers.
III. Evaluate the efficacy of black raspberry phytochemicals and their metabolites in reversing the effect of smoking on oral host-microbial interactions.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive bioactivity of black raspberry phytochemical-rich delivery vehicle (BRB nectar) orally (PO) once daily (QD) for 12 weeks.
ARM II: Participants receive placebo nectar PO QD for 12 weeks.
Дати
Последна проверка: | 07/31/2019 |
Първо изпратено: | 05/05/2015 |
Очаквано записване подадено: | 05/05/2015 |
Първо публикувано: | 05/07/2015 |
Изпратена последна актуализация: | 08/15/2019 |
Последна актуализация публикувана: | 08/18/2019 |
Действителна начална дата на проучването: | 05/31/2014 |
Приблизителна дата на първично завършване: | 06/29/2018 |
Очаквана дата на завършване на проучването: | 08/29/2020 |
Състояние или заболяване
Интервенция / лечение
Other: Laboratory Biomarker Analysis
Dietary Supplement: Arm I (BRB nectar)
Other: Arm II (placebo nectar)
Other: Screening Questionnaire Administration
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Experimental: Arm I (BRB nectar) Participants receive BRB nectar PO QD for 12 weeks. | Dietary Supplement: Arm I (BRB nectar) Given BRB nectar PO |
Placebo Comparator: Arm II (placebo nectar) Participants receive placebo nectar PO QD for 12 weeks. | Other: Arm II (placebo nectar) Given PO |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - Subjects must be periodontally healthy; this is defined as all sites with attachment levels =< 2 mm and probing depths =< 3 mm) and caries-free, as evidenced by a DMF (decayed, missing, filled teeth) Index of less than 5 - Subject must be either a current smoker or a never smoker; to define a smoker, we will utilize the Centers for Disease Control definitions; any individual who is currently smoking and has smoked more than 100 cigarettes in their lifetime will be identified as a current smoker; smoking status will be assessed by a questionnaire; since only current and never smokers are included, it is not necessary to measure cotinine levels; the number of cigarettes smoked per day and years of smoking will be used to calculate pack-years, which will be used as a measure of tobacco exposure; a never smoker is defined as a person who never smoked, or smoked less than 100 cigarettes in their lifetime, and who has not had a cigarette in over ten years - Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition, dietary or alternative medications/supplements for the duration of the study - Agree to follow a controlled ellagitannin/low polyphenolic diet and to document consumption of polyphenolic foods each day of the study using our easy to document daily form Exclusion Criteria: - Have history of oral cancer or carcinoma in-situ - Have had antibiotic therapy or professional cleaning within the previous 3 months - Require antibiotic therapy prior to oral cleaning - Have an active metabolic or digestive illness that impact phytochemical absorption and metabolism, including: diabetes, malabsorptive disorders (Crohn's disease, documented celiac disease, etc.), renal insufficiency (creatinine [Cr] > 1.4), hepatic insufficiency (nonalcoholic steatohepatitis [NASH], cirrhosis, active viral hepatitis), hyper- or hypothyroidism, or short bowel syndrome - Are alcohol consumers (defined as an average consumption of greater than 1 drink/day over one week [wk] [one drink = 1 oz. liquor, 12 oz. beer]) - Are taking immunosuppressant medications, bisphosphonates or steroid medications - Currently undergoing treatment for cancer with chemotherapy, hormone therapy, radiation, or biological therapy - Have a known allergy or food intolerance to ingredients in study products (black raspberries or other berries) - Are planning to conceive, or are currently pregnant or lactating - Have had any active oral lesions in the past month or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening - Are taking any medications that have known impact on immune responses (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] for chronic pain) or are actively being investigated for the prevention of tobacco related cancers will not be acceptable; a single 81 mg aspirin per day will be acceptable |
Резултат
Първични изходни мерки
1. Change in the microbial shift [Baseline to 12 weeks]
2. Change of metabolite profile in saliva, urine, and blood using high-performance liquid chromatography-mass spectrometry [Baseline to up to 12 weeks]
Вторични изходни мерки
1. Food frequency (FF) using the Viocare FF Questionnaire [Week 0]
2. Gene expression levels using next generation sequencing (NGS) [Up to 12 weeks]