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临床试验/NCT06127511
NCT06127511已完成不适用

Peanut Consumption on Cognitive Performance, Weight Management, and Inflammation in Young Adolescents

University of Barcelona1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年1月29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
142
试验地点
1
主要终点
Changes in assessment of interference and cognitive control in healthy young adolescents after a daily intake of peanuts.

研究概览

简要总结

A multi-school, two-arm parallel cluster-randomized controlled trial will be conducted in 200 healthy young adolescents from Barcelona (Spain) to evaluate the effect of peanut consumption on cognitive performance, weight management and inflammation. Schools willing to participate will be randomly assigned to either the intervention or the control group. After the recruitment, the participants will follow a peanut-free diet for two weeks. Both arms will receive a multidimensional educational intervention designed by the Gasol Foundation to promote healthy dietary habits based on Mediterranean diet recommendations, along with exercise performance, healthy sleeping habits and emotional knowledge. Half of the participants (intervention group) will consume 25 g of whole skin roasted peanuts as a daily snack to be incorporated into their diet for six months.

详细描述

Background:

Regular nut consumption has been associated with reduced inflammation, oxidative damage, and improved vascular function, which may benefit cognitive function. Their content in phenolic acids, mainly p-coumaric and isoferulic acids may help prevent and cure diseases including Alzheimer's, diabetes, cancer, hypertension, and atherosclerosis that are associated with oxidative stress suggesting it could be used as a potential new neuroprotective tactic. Polyphenols have been shown to influence gut microbiota composition and activity, and their metabolites, including short-chain fatty acids (SCFAs), may modulate brain biochemistry by acting as neurotransmitters in the central nervous system, potentially leading to effects against depression and neurodegenerative disease.

Childhood is an important period for brain development, and nutrients aid the formation of new synaptic connections and support learning processes at school and in home environments. Adolescence is also a period where brain connectivity and complex behaviours are further refined. While a positive association has been observed between the consumption of healthy foods (fruits, vegetables, whole grains, fish, nuts, dietary fiber) and cognitive function, research on the association between nut consumption and cognitive health during adolescence is scarce.

In addition, evidence shows that incorporating peanut and peanut-based products into the diet does not lead to weight gain or higher body weight and may even promote long-term weight maintenance and increase linear growth due to their arginine content.

Due to the potential benefits of schools in preventing overweight and obesity, and the lack of research on the relationship between nut consumption and cognitive health during childhood and adolescence, the investigators plan to conduct an intervention study to investigate the association between peanut consumption and cognitive ability, weight management and inflammation in Spanish children aged 10-12 years. As the nutritional composition of peanuts can vary depending on their form, this study will examine the impact of the regular consumption of 25g of whole-skin roasted peanuts on cognitive function, mood, and school performance in healthy young adolescents.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Eligible participants will be young adolescents, boys and girls, aged between 10 and 12 years who attend regular primary schools in Barcelona. The schools will assist with the participant recruitment through the classes and after that, a total of one-hundred students will be randomly included in each group. In all cases, participation will be voluntary and informed consent will be obtained prior to the study.

排除标准

  • •The exclusion criteria will be history of allergy or intolerance to peanuts, any medical conditions or dietary restrictions that would affect peanut consumption, being able to understand Spanish or Catalan, and use of antibiotics in the month prior to the study.

研究组 & 干预措施

Peanuty group

Experimental

Families allocated in the intervention group will receive the whole skin roasted peanuts packed in daily doses (25 g per day, 750 g per month), starting the day that we will visit the participants for the first time. They will consume 25 g of whole skin roasted peanuts as a daily snack to be incorporated into their diet for six months.

干预措施: Food (peanut) (Other)

Control group

No Intervention

Usual care

结局指标

主要结局

Changes in assessment of interference and cognitive control in healthy young adolescents after a daily intake of peanuts.

时间窗: Baseline and after 6 months

To measure the assessment of interference and cognitive control, the Stroop test will be used.

Changes in pro- and anti-inflammatory biomarkers after a daily intake of peanuts in healthy young adolescents.

时间窗: Baseline and after 6 months

Cytokines (pg/mL), Monocyte chemoattractant protein-1 (MCP-1) (pg/mL), interleukin (IL)-6 and 10 (pg/mL), (mg/dL) will be assayed by immunoenzymatic methods.

Changes in the depression score in healthy young adolescents after a daily intake of peanuts.

时间窗: Baseline and after 6 months

To measure depression score, the CDI Childhood Depression Inventory test will be used.

Changes in processing speed, attention span and working memory in healthy young adolescents after a daily intake of peanuts.

时间窗: Baseline and after 6 months

To measure processing speed, attention span and working memory, the WISC-V Digits and Codes Subtest will be used.

Changes in Social cognition (emotion recognition and theory of mind) in healthy young adolescents after a daily intake of peanuts.

时间窗: Baseline and after 6 months

To measure Social cognition (emotion recognition and theory of mind), the NEPSY-II subtest will be used.

Changes in vascular biomarkers after a daily intake of peanuts in healthy young adolescents.

时间窗: Baseline and after 6 months

sVCAM-1 and sICAM-1 (ug/mL) will be assayed by immunoenzymatic methods.

Changes in the ability to concentrate, selective attention and processing speed in healthy young adolescents after a daily intake of peanuts.

时间窗: Baseline and after 6 months

To measure the ability to concentrate, selective attention and processing speed, the d2-R Attention Test (Revised) will be used.

Changes in attention and inductive reasoning in healthy young adolescents after a daily intake of peanuts.

时间窗: Baseline and after 6 months

To measure in attention and inductive reasoning, the Raven-2 test will be used.

Changes in adiposity molecules after a daily intake of peanuts in healthy young adolescents

时间窗: Baseline and after 6 months

Adiponectin and adipsin (ug/mL), leptin (pg/mL), ghrelin (pg/mL), visfatin (pg/dL), resistin (pg/mL), insulin (pg/mL), glucagon (pg/dL), peptid C (pg/mL) and, PAI-1 (pg/mL) will be assayed by immunoenzymatic methods.

Changes in body mass index after a daily intake of peanuts in healthy young adolescents

时间窗: Baseline, 3 and after 6 months

Body mass index (kg/m\^2) are calculated after measure weight (kg) and height (meter).

次要结局

  • Changes in blood glucose after a daily intake of peanuts in healthy young adolescents(Baseline and after 6 months)
  • Changes in heart rate after a daily intake of peanuts in healthy young adolescents(Baseline, 3 and after 6 months)
  • Changes in nutrients and energy intake after regular peanut in healthy young adolescents(Baseline and after 6 months)
  • Pubertal changes in healthy young adolescents after a daily intake of peanuts.(Baseline and after 6 months)
  • Changes in lipidic profile after a daily intake of peanuts in healthy young adolescents(Baseline and after 6 months)
  • Changes in waist circumference after a daily intake of peanuts in healthy young adolescents(Baseline, 3 and after 6 months)
  • Changes in blood pressure after a daily intake of peanuts in healthy young adolescents(Baseline, 3 and after 6 months)
  • Changes in sleep quality after regular peanut in healthy young adolescents(Baseline and after 6 months)
  • Changes in the gut microbiota after a daily intake of peanuts in fecal samples of healthy young adolescents.(Baseline and after 6 months)
  • Changes in the polyphenols and their metabolites after a daily intake of peanuts in biological samples of healthy young adolescents.(Baseline and after 6 months)
  • Changes in percentage of body fat in healthy young adolescents after a daily intake of peanuts.(Baseline, 3 and after 6 months)
  • Changes in physical activity after regular peanut in healthy young adolescents(Baseline and after 6 months)
  • Changes in the short-chain fatty acids after a daily intake of peanuts in biological samples of healthy young adolescents.(Baseline and after 6 months)

研究者

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

Rosa M Lamuela-Raventós

Professor

University of Barcelona

研究点 (1)

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