The Influence of Honey-flavored Yogurt on Low-grade Inflammation and Gut Health in Middle to Older Aged Women.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Concentration of CD4+ T Helper (TH)17 cytokines
研究概览
简要总结
A randomized, double-blind, crossover dietary intervention trial will test the effects of 4 weeks of daily honey-flavored yogurt intake on markers of inflammation (Th17 cytokines) and oxidative stress (NOX2, UA, RSNO) and associative changes with microbial derived metabolites (SCFAs, BAs, ellagitannins), metabolism and the fecal microbiome. The above suite of selected markers will capture diet-induced systemic changes in inflammation and oxidative stress, while assessing associated microbial changes.
详细描述
Those qualified for enrollment will be randomized into a double-blind crossover study to consume 2 morning servings of a 0.6 cup (150g) of plain yogurt with : A) cane sugar added in an isocaloric level as the honey or, B) 1 tbsp of phenolic-rich honey for 4 weeks. A one-month washout between periods will be used. The participants will be instructed to consume one yogurt in replacement of or as part of breakfast, and as a late morning snack. They will also be instructed to not add any additional items to the yogurt. Therefore, each study participant will consume 2 tbsp. of honey a day for four weeks, which is a realistic amount typically consumed by honey users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The honey intervention or isocaloric amounts of sugar will be provided in yogurt. The study participant will not be told what sweetener they will be receiving.
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal female: 45-65 years
- •Women: lack of menses for at least two years.
- •Subject is willing and able to comply with the study protocols.
- •Subject is willing to participate in all study procedures
- •BMI 25.0 - 30.0 kg/m2
排除标准
- •BMI ≥ 31 kg/m2
- •Food allergies
- •Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
- •Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
- •Use of concentrated food supplements/powders and extracts
- •Fruit consumption > 2 cups/day
- •Vegetable consumption >3 cups/day
- •Self-reported restriction of physical activity due to a chronic health condition
- •Self-reported chronic/routine high intensity exercise
- •Self-reported diabetes
- •Blood pressure ≥ 140/90 mm Hg
- •Self-reported renal or liver disease
- •Self-reported heart disease, which includes cardiovascular events and stroke
- •Abnormal Metabolic or CBC panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
- •Self-reported cancer within past 5 years
- •Self-reported malabsorption
- •Currently taking prescription drugs or supplements.
- •Supplement use other than a general formula of vitamins and minerals that meet the RDA
- •Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
- •Indications of substance or alcohol abuse within the last 3 years
- •Cannabis use
- •Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL]. (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp)
- •Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL]. (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp);
- •Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL], and a Framingham 10-year Risk Score 10-20% (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp).
- •Current enrollee in a clinical research study.
研究组 & 干预措施
Honey sweetened yogurt
1 tbsp. of honey in 0.6 cup (150g) of plain yogurt. The participants will be asked to consume 2 morning servings of the yogurt for a total of 2 tbsp. of the assigned honey per day.
干预措施: Honey sweetened yogurt (Other)
Sugar sweetened yogurt
Sugar will be added to 0.6 cup (150g) of plain yogurt in an isocaloric amount compared to the honey. The participants will be asked to consume 2 morning servings of the yogurt per day.
干预措施: Sugar sweetened yogurt (Other)
结局指标
主要结局
Concentration of CD4+ T Helper (TH)17 cytokines
时间窗: 4 weeks
Cytokines included in the panel are: Il-1b, IL-4, IL-6, IL-10, IL-17a, IL-21, IL-22, IL-23, IL-31, IL-33, IFN-gamma, TNF-alpha, IL-17f.
次要结局
- Concentration of Secondary bile acids(4 weeks)
- Concentration of urolithins and other ellagitannin-derived metabolites(4 weeks)
- Concentration of soluble NADPH oxidase (NOX2)(4 weeks)
- Concentration of total Nitrate/Nitrite and Nitric Oxide related metabolites (RSNO)(4 weeks)
- Concentration of uric acid(4 weeks)
- Concentration of untargeted metabolomics(4 weeks)
- Concentration of Short chain fatty acids(4 weeks)
- Determination of microbial populations(4 weeks)