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临床试验/NCT05928741
NCT05928741已完成不适用

Short-term Effects of Fruit Juice Enriched With Vitamin D3, n-3 Fatty Acids, and Probiotics on Subjective Appetite, Energy Intake, and Glycemic Responses, in Healthy Adults

Agricultural University of Athens1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月2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
50
试验地点
1
主要终点
Subjective appetite rating

研究概览

简要总结

This study investigated the short-term effects of fruit juice enriched with vitamin D3, n-3 fatty acids, and probiotics on subjective appetite, energy intake, and glycemic responses, in both normal-weight and overweight, healthy adults.

详细描述

This study aimed to 1. Assess the subjective appetite of participants after the consumption of fruit juice (100% orange) enriched with vitamin D3, n-3 fatty acids, and probiotics compared to regular fruit juice (without any fortification), and 2. Examine the short-term effects of enriched fruit juice compared to regular fruit juice on glycemic responses and blood pressure, in both normal-weight and overweight healthy adults

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Triple-blind (participant, investigator, outcomes assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy Non-diabetic men and women Body mass index between 18.5 and 29.9 kg/m2

排除标准

  • •Severe chronic disease (i.e., cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
  • •Gastrointestinal disorders
  • •Pregnancy
  • •Lactation
  • •Competitive sports
  • •Alcohol abuse
  • •Drug dependency

研究组 & 干预措施

Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload

Experimental

Twenty-three healthy adults with normal weight and twenty-three healthy adults with overweight consumed a standardized breakfast after a 12-hour fast. Two hours later they were given 50 g of available carbohydrates from the two preloads (enriched orange juice or control orange juice) in a random order, and 3 hours after the preload they were offered an ad libitum lunch. Foods were weighed at the time of serving and any leftovers were weighed again after lunch to determine the amount of food consumed. There was a washout period of at least one week between the two visits. Fingertip capillary blood glucose samples were collected at baseline and at several time points after food intake. Visual analog scales (VAS) of 100 mm were collected to assess subjective appetite. Blood pressure was measured at several time-points.

干预措施: Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload (Behavioral)

Control orange juice without vitamin D3, n-3 fatty acids, and probiotics as preload

Experimental

Twenty-three healthy adults with normal weight and twenty-three healthy adults with overweight consumed a standardized breakfast after a 12-hour fast. Two hours later they were given 50 g of available carbohydrates from the two preloads (enriched orange juice or control orange juice) in a random order, and 3 hours after the preload they were offered an ad libitum lunch. Foods were weighed at the time of serving and any leftovers were weighed again after lunch to determine the amount of food consumed. There was a washout period of at least one week between the two visits. Fingertip capillary blood glucose samples were collected at baseline and at several time points after food intake. Visual analog scales (VAS) of 100 mm were collected to assess subjective appetite. Blood pressure was measured at several time-points.

干预措施: Orange juice with vitamin D3, n-3 fatty acids, and probiotics as preload (Behavioral)

结局指标

主要结局

Subjective appetite rating

时间窗: 7 hours

Useful change in subjective appetite using visual analogue scales (VAS). Participants rated their hunger, desire to eat, perceived fullness, thirst, preoccupation with food, pleasure of eating the consumed test food, and thirst, after eating on a horizontal line VAS, with a line length of 100 mm and width of 3 desktop publishing points, that was black, had flat line endpoints, had an ascending numerical order of scale endpoints \[i.e., "0" and "10", for example neither hungry (0 mm), full (100 mm) or have desire for food in the middle (50 mm)\], and used "0" and "100" as numerical anchors below the left and right endpoints, respectively.

次要结局

  • Energy intake after preload and the next 24 hours(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aimilia Papakonstantinou

Assistant Professor

Agricultural University of Athens

研究点 (1)

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