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临床试验/NCT03526094
NCT03526094已完成不适用

Flavanol Absorption, Metabolism and Excretion From Fruit-based Drinks and Other Food Matrixes

University of California, Davis2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Flavanol metabolites in plasma

研究概览

简要总结

Dietary intervention study in healthy adult males to evaluate concentration of flavanol metabolites in plasma and urine after single acute intakes of flavanols from different fruit-based drinks.

详细描述

Flavonoids, including the sub groups of Flavanols (F) are plant-derived compounds commonly present in the human diet. Examples of F-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of F-containing foods and beverages has been associated with improvements in cardiovascular health. In this context, there exists a great interest in describing the absorption, metabolism and excretion of F in humans, as it is thought that F-derived metabolites present in circulation are the mediators of F-beneficial effects in humans. Recently, the investigators described a series of F-derived metabolites in circulation that are present after the consumption of a single acute intake amount of F in humans as well as F-metabolites derived from the metabolic activity of the gut microbiome. A key question, however, is if the metabolites we observed after a single acute feeding are the same as those that occur in individuals who consume F-rich diets on a regular basis. Studies investigating the metabolism of numerous other xenobiotics have shown that the profile of metabolites can greatly vary over time, as well as with the amount of the xenobiotic ingested. In this context, the investigators submit it is important to assess whether or not there are food matrix-dependent effects on the levels and profile of F-derived metabolites in humans. The investigators suggest the information that will be obtained from the outlined work will be particularly timely given ongoing discussion concerning the possible generation of dietary recommendations for F-rich foods and increasing interest in the putative health effects of F intake in humans.

This study consisted of two parts. One part investigated flavanols absorption and metabolism from different fruit-based drinks and other food matrixes. The second part investigated flavanol absorption and metabolism after the intake of a flavanol drink alone and simultaneously consumed with a banana-based drink.

Following the beginning of the trial, an advanced method to analyze cocoa flavanols was accredited by AOAC International as a First Action Official Method of Analysis https://doi.org/10.1093/jaoacint/qsaa132). This updated method relies on a reference material (RM8403) recently standardized and made commercially available by the U.S. National Institute of Standards and Technology. While the actual cocoa flavanol content of our intervention remained unchanged throughout the trial, the application of this new analytical method led to expected changes in how the total cocoa flavanol content is now reported. Applying AOAC 2020.05/RM8403 to our intervention, the total cocoa flavanol content of select arms in our trials have been updated accordingly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Investigator)

盲法说明

Investigator processing samples and performing statistical analyses

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •No prescription medications
  • •BMI 18.5 - 29.9 kg/m2
  • •Weight ≥ 110 pounds
  • •previously consumed cocoa, peanut, parsley, celery and chamomile products with no adverse reactions

排除标准

  • •Adults unable to consent
  • •Prisoners
  • •Non-English speaking*
  • •BMI ≥ 30 kg/m2
  • •Performing vigorous physical activity (i.e. more than 6 MET; metabolic equivalence of task as defined by CDC and ACSM guidelines (http://www.cdc.gov/physicalactivity/everyone/glossary/index.html#vig-intensity; and http://www.cdc.gov/nccdphp/dnpa/physical/pdf/PA_Intensity_table_2_1.pdf ) for more than 3 days a week.
  • •Dietary allergies including those to nuts, cocoa and chocolate products, parsley, celery and chamomile.
  • •Active avoidance of coffee and caffeinated soft drinks
  • •Under current medical supervision
  • •A history of cardiovascular disease, stroke, renal, hepatic, or thyroid disease
  • •History of clinically significant depression, anxiety or other psychiatric condition
  • •History of Raynaud's disease
  • •History of difficult blood draws
  • •Indications of substance or alcohol abuse within the last 3 years
  • •Current use of herbal, plant or botanical supplements (multi-vitamin/mineral supplements are allowed)
  • •Blood Pressure > 140/90 mm Hg
  • •GI tract disorders, previous GI surgery (except appendectomy)
  • •Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas)
  • •Diarrhea within the last 3 months, or antibiotic intake within the last 3 months
  • •Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individuals following diets with significant deviations from the average diet
  • •Metabolic panel and cholesterol results or complete blood counts that are outside of the normal reference range and are considered clinically relevant by the study physician
  • •Cold, flu, or upper respiratory condition at screening
  • •Currently participating in a clinical or dietary intervention study

研究组 & 干预措施

Flavanols-capsules

Active Comparator

Capsules containing 541 mg cocoa flavanols (75 mg epicatechin) and 315 g of milk (1% fat)

干预措施: Flavanols-capsules (Other)

Flavanol-banana blend

Experimental

Fruit blend prepared by mixing 177 g ripe, frozen bananas, 240 g almond milk and a chocolate flavored powder containing 638 mg cocoa flavanols (88 mg epicatechin)

干预措施: Flavanol-banana blend (Other)

Flavanol-high protein drink

Experimental

Drink prepared by mixing 225 mL of a chocolate flavored high protein dairy drink with a CF powder containing 565 mg cocoa flavanols (78 mg epicatechin)

干预措施: Flavanol-high protein drink (Other)

Flavanol-berry blend

Experimental

Fruit blend prepared by mixing 120 g almond milk, 70 g water, 95 g yogurt, 50 g each strawberries, blueberries, blackberries, raspberries, 105 g crushed ice and a fruit-flavored powder containing 484 mg cocoa flavanols (68 mg epicatechin)

干预措施: Flavanol-berry blend (Other)

Flavanol-sports drink

Experimental

Drink prepared by mixing 488 g of a sports drink with a CF powder containing 565 mg cocoa flavanols (78 mg epicatechin)

干预措施: Flavanol-sports drink (Other)

Flavanol-peanut butter toast

Experimental

Prepared by mixing 32 g peanut butter with a chocolate flavored powder containing 653 mg cocoa flavanols (85 mg epicatechin) and spread on 1 slice toasted bread (50 g) and 50 g sliced strawberries

干预措施: Flavanol-peanut butter toast (Other)

Flavanol-oats

Experimental

Prepared by mixing 40 g quick oats with 237 g boiling water and combined with a chocolate flavored powder containing 653 mg cocoa flavanols (85 mg epicatechin)

干预措施: Flavanol-oats (Other)

Flavanol-yogurt

Experimental

Prepared by 227 g yogurt (0% fat) mixed with a fruit-flavored powder containing 484 mg cocoa flavanols (68 mg epicatechin)

干预措施: Flavanol-yogurt (Other)

II- Flavanol drink

Active Comparator

Drink prepared by mixing 240 g almond milk with a chocolate flavored powder containing 638 mg cocoa flavanols (88 mg epicatechin)

干预措施: II- Flavanol drink (Other)

II- Flavanol drink + banana blend

Experimental

Drink 1 (Flavanol drink): prepared by mixing 120 g almond milk with 638 mg cocoa flavanols (88 mg epicatechin) Drink 2 (Fruit blend): prepared by mixing 120 g almond milk blended with 177 g ripe, frozen bananas

干预措施: II- Flavanol drink + banana blend (Other)

结局指标

主要结局

Flavanol metabolites in plasma

时间窗: Before to 6 h post test material intake

Plasma concentration of flavanol metabolites

次要结局

  • Flavanol metabolites in urine(12 h before to 24 h post test material intake)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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