Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Gastrointestinal Tolerance
研究概览
简要总结
Coffee processing byproducts, such as coffee cascara (outer skin and pulp of the coffee berry), have potential health promoting properties due to the presence of bioactive compounds. Its use as a novel food ingredient is a means of valorizing this fractioin in the elaboration of functional yogurts. The addition of cascara extract in yogurt affects its texture quality. The addition of dietary fiber can help regain the structure of the yogurt's gel. However, secondary gastrointestinal effects associated with acute fiber ingestion must be considered.The aim of this clinical trial is to study the gastrointestinal tolerance, satiation and sensory acceptance of yogurts containing both coffee cascara extract and different doses of commercial soluble dietary fiber.
详细描述
Forty healthy volunteers will be recruited and distributed into 4 groups following a randomized, blind, crossover design. Yogurt formulations will be administered two hours after the ingestion of a standardized breakfast, as a snack. Yogurt formulations include:
- Control cascara yogurt with 0% dietary fiber.
- Cascara yogurt with 3% dietary fiber.
- Cascara yogurt with 7% dietary fiber.
- Cascara yogurt with 13% dietary fiber.
The study will be conducted in 4 sessions, with at least 48h of washout period between treatment days. Data on gastrointestinal tolerance, satiation and sensory acceptance will be taken on the same day of the treatment using online surveys.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers.
排除标准
- •Food allergies.
- •Lactose intolerant.
- •Allergic to milk proteins.
- •Diagnosed gastrointestinal disease.
- •Pregnant, trying to become pregnant or breast feeding.
- •Caffeine sensibility.
- •Dietary fiber intolerance.
研究组 & 干预措施
Control yogurt
Treatment with a control yogurt with cascara but no dietary fiber.
干预措施: Control yogurt (Other)
Yogurt with fiber
Treatment with yogurts containing cascara and 3%, 7% and 13% of dietary fiber.
干预措施: Dietary fiber (Other)
结局指标
主要结局
Gastrointestinal Tolerance
时间窗: 2 hours after ingestion
Self reported gastrointestinal symptoms including bloating, nausea, flatulence, cramping, diarrhea, constipation and rumbling. Severity of symptoms will be measured with a 4-point scale (0= none, 1= mild, 2=moderate, 3= severe).
次要结局
- Satiety(At 0, 15, 60, 115, 125, 150, 180, 210 and 240 minutes after breakfast meal.)
- Sensory acceptance(up to 5 minutes (At the moment of eating the yogurt))
研究者
Maria Dolores del Castillo
Principal Investigator
National Research Council, Spain