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临床试验/NCT06704178
NCT06704178已完成不适用

A Randomized Double-blind Placebo-controlled Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes.

NuBest1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月12日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Change Mean Percentile Score in Digit Span
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A 6-month virtual two-armed randomized double-blind placebo-controlled clinical trial. Participants will take NuBest Tall Growth Protein Powder or a placebo daily. Parents will complete questionnaires at baseline and monthly, and children will undergo cognitive assessments and height/weight measurements at specified intervals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The study is double-blind; participants, care providers, investigators, and outcomes assessors are all masked to the allocation of intervention or placebo.

入排标准

年龄范围
10 Years 至 16 Years（Child）
性别
All
接受健康志愿者
是

入选标准

  • •Interested in their child trialing a dietary supplement designed to improve overall health outcomes in children including height, maintenance of a healthy weight, cognitive function, immune function, and energy levels.
  • •Willing to refrain from giving their child any vitamins, minerals, or herbal supplements of any kind for the duration of the study.
  • •Parents willing to weigh and measure the height of their child throughout the study.
  • •Generally healthy - do not have any uncontrolled chronic disease.

排除标准

  • •Any child with a history of endocrine disorder, heart disease, lung disease, kidney disease, digestive disease, or skeletal dysplasia.
  • •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
  • •Is undergoing or planning to undergo significant medical procedures in the next six months.
  • •A history of severe allergic reactions, including but not limited to any of the product's ingredients.
  • •Any child with a dairy allergy or lactose intolerance.
  • •Has undergone any surgeries or invasive treatments in the last six months.
  • •Has had any major illness in the last three months.
  • •Having any planned invasive medical procedures during the study period.
  • •Currently participating in any other clinical study.
  • •Unwilling to follow the study protocol.
  • •Any child diagnosed with attention-deficit disorder (ADD) or attention-deficit hyperactivity disorder (ADHD).
  • •Any child currently taking or have taken in the last 3 months any prescription medication targeting ADD or ADHD (such as Adderall, Concerta, Focalin, Evekeo, or Ritalin).
  • •Any child that is a 'fussy' eater or who the parent suspects may not tolerate consuming the test product daily for six months.

研究组 & 干预措施

Intervention Arm

Experimental

Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months.

干预措施: NuBest Tall Growth Protein Powder (Dietary Supplement)

Placebo Arm

Placebo Comparator

Participants in this arm will take a placebo product daily for 6 months.

干预措施: Placebo Powder (Dietary Supplement)

结局指标

主要结局

Change Mean Percentile Score in Digit Span

时间窗: Baseline to Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Change Mean Percentile Score in Token Search

时间窗: Baseline to Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Change Mean Percentile Score in Double Trouble

时间窗: Baseline and Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

IChange Mean Percentile Score in Feature Match

时间窗: Baseline and Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Change Mean Percentile Score in Grammatical Reasoning

时间窗: Baseline to Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Change Mean Percentile Score in Digit Span

时间窗: Baseline to Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Change Mean Percentile Score in Token Search

时间窗: Baseline to Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

次要结局

  • Change in Parents' Perception of the Child's Health in the Future.(Monthly from Baseline to Month 6)
  • Parents' Perception of the Change in Child's Health Compared to One Month Ago.(Monthly from Baseline to Month 6)
  • Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs(Monthly from Baseline to Month 6)
  • Change in Limitations in the Kind of Schoolwork or Activities Undertaken.(Monthly from Baseline to Month 6)
  • Change in Limitations During the Completion of Schoolwork or Activities.(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Health Compared to Other Children.(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Immunity(Monthly from Baseline to Month 6)
  • Change in Parents' Worry About Child's Health(Monthly from Baseline to Month 6)
  • Change in Parent-reported Frequency of Child's Stomach Aches(Monthly from Baseline to Month 6)
  • Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet(Monthly from Baseline to Month 6)
  • Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Increase in Height - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Changes in Weight - Nubest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Changes in Weight - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6.)
  • Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6.)
  • Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6.)
  • Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6.)
  • Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Increase in Height(Baseline, Month 2, Month 4, and Month 6)
  • Changes in Weight(Baseline, Month 2, Month 4, and Month 6)
  • Changes in Overall Health as Reported by Parents(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of the Child's Health in the Future.(Monthly from Baseline to Month 6)
  • Parents' Perception of the Change in Child's Health Compared to One Month Ago.(Monthly from Baseline to Month 6)
  • Change in Child's Energy Levels as Reported by Parents(Monthly from Baseline to Month 6)
  • Changes in Limitations When Completing High-Intensity Activity(Monthly from Baseline to Month 6)
  • Changes in Limitations When Completing Moderate-Intensity Activity(Monthly from Baseline to Month 6)
  • Changes in Limitations When Moving Around(Monthly from Baseline to Month 6)
  • Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs(Monthly from Baseline to Month 6)
  • Change in Limitations When Bending, Lifting, or Stooping.(Monthly from Baseline to Month 6)
  • Change in Limitations in the Kind of Schoolwork or Activities Undertaken.(Monthly from Baseline to Month 6)
  • Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.(Monthly from Baseline to Month 6)
  • Change in Limitations During the Completion of Schoolwork or Activities.(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Health Compared to Other Children.(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Immunity(Monthly from Baseline to Month 6)
  • Change in Parents' Worry About Child's Health(Monthly from Baseline to Month 6)
  • Change in Parent-reported Frequency of Child's Stomach Aches(Monthly from Baseline to Month 6)
  • Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet(Monthly from Baseline to Month 6)
  • Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Increase in Height - Nubest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Increase in Height - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Changes in Weight - Nubest Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Changes in Weight - Placebo Group Only (Within-Group Analysis)(Baseline to Month 6)
  • Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6.)
  • Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6.)
  • Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6.)
  • Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6.)
  • Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)
  • Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)(Monthly from Baseline to Month 6)

研究者

发起方
NuBest
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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