Elderberry Consumption and Human Health: a Preliminary Investigation Into Effects on Indirect Calorimetry, Insulin Sensitivity, and Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Substrate oxidation
研究概览
简要总结
The objective of this human study is to determine if the metabolic benefits observed with other anthocyanin-rich berries extend to elderberries. To accomplish this, we performed a short-term controlled feeding study in overweight but healthy volunteers in a placebo-controlled crossover clinical trial. Major study endpoints included blood glucose and insulin response to a high-carbohydrate meal challenge, indirect calorimetry, and profiling of the fecal microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Double (ParticipantOutcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above
排除标准
- •Pregnant or trying to become pregnant
- •Have a body mass index less than 25 kg/m2
- •Are younger than 22 years of age, or older than 75 years of age
- •Known allergy or intolerance to elderberries
- •History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring a special diet that is not in accord with the diet behavior requested for this study
- •Adherence to restrictive (vegetarian or vegan) or extreme (fad [ex. Ketogenic or Atkins] or quick weight loss/gain) diet patterns and unwillingness to consume a conventional, omnivorous diet and maintain body weight
- •Habitual use of tobacco (including vaping) products in the last 6 months
- •Diagnosis or treatment of cancer in the past 3 years
- •Crohn's disease or diverticulitis
- •Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
- •Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
- •Type 2 diabetes requiring the use of medication
- •Fasting blood glucose > 125 mg/dL
- •Unable or unwilling to give informed consent or communicate with study staff
- •Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
研究组 & 干预措施
Placebo Comparator: Placebo beverage
Participants will consume placebo beverage twice/day for 1-week as well as our provided diet for 4 days.
干预措施: Placebo Beverage (Other)
Experimental: Elderberry Juice
Participants will consume elderberry juice twice/day for 1-week as well as our provided diet for 4 days.
干预措施: Elderberry Juice (Other)
结局指标
主要结局
Substrate oxidation
时间窗: 3.5 hours
Participants will be monitored by a metabolic cart at rest and while walking
Glucose tolerance/insulin sensitivity
时间窗: 3 hours
Blood will be collected following a meal tolerance test
Gut Microbiome analysis
时间窗: 5 minutes
Feces will be collected before and after the intervention
次要结局
未报告次要终点