Clinical trial NCT05281146: Production of Fortified Biscuit With Chickpea and Crushed Peanut for Improving Cognitive Performance
Official title: Production of Fortified Biscuit With Chickpea and Crushed Peanut and Evaluating Its Effectiveness in Terms of Its Acceptability and Cognitive Performance: a Pilot Study Among Egyptian Primary School-aged Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Keywords: chickpea
crushed peanut
Wheat germ
Cinnamon
short-term memory
working memory
visual memory
information processing
auditory attention ability
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Theoretically, fortified biscuits based on chickpea flour and crushed peanuts in addition to wheat germ, and Cinnamon help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving cognitive abilities of school aged children. It is important to practically evaluate the effectiveness of the fortified biscuits intake for 4 months in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village. Eighty Children were randomly allocated in either chickpea and peanuts biscuits dependent group (40 children) or the non-dependent group (40 children).
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is well known that globally, school-based fortification and school feeding approaches have been applied to remedy nutritional deficiencies that impact health in the primary school age group.

Aim of the study: to produce a fortified biscuit with chickpea and crushed peanut. To evaluate the effectiveness of the fortified biscuits intake for 4 months in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village. The fortified biscuits' effect on auditory attention, visual and working memory, and learning ability was evaluated.

Methodology: This study was an interventional study conducted in two stages: stage one was the production of nutritious biscuits that is based on chickpea flour and peanut in addition to whole wheat (extract 72 %), wheat germ, cinnamon, milk, and egg. All these constituents help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving the cognitive abilities of school-aged children. During stage two, eighty Children were randomly allocated in either chickpea and peanuts biscuits dependent group (40 children) or non-dependent group (40 children) to evaluate the impact of the fortified biscuits. All enrolled children and their mothers received 5 cognitive stimulation sessions over four months. The cognitive performance of primary school-aged children was assessed before and after the interventions by a battery of four verbal \& non-verbal intelligence psychological tests. These tests covered short-term and working memory, visual memory, and the ability for categorization, learning for speed of information processing, and auditory attention ability with rising levels of difficulty. These tests were: Digit Span, the figural memory tests, Coding and Auditory vigilance tests A and B respectively. Five items were used to evaluate the physical characteristics of the biscuits: color, odor, taste, consistency, and general acceptance.

Detailed description: Nutritional factors are one of the interacting factors to affect all developmental aspects among Egyptian children since birth. During the first two years of life, Egyptian studies put more emphasis on child nutrition and development with intensive efforts around breastfeeding because of being a critical period of rapid change. During this phase, studies were implemented to prepare children for subsequent developmental competency in their childhood by investigating the risk factors affecting the early cognitive development of Egyptian infants, and monitoring their cognitive performance. Later on in life, more emphasis was put on either studying factors behind malnutrition or providing educational and nutritional interventions to enhance growth and development.

To address the nutritional needs of school-aged children, global efforts have extensively focused on school-based fortification approaches for school feeding programs (SFPs). SFPs are linked to Goal number 2 (zero hunger) of the Sustainable Development Goals (SDG). The Ministry of Agriculture and Land Reclamation (MOLAR) in Egypt has directed SFP since 1998 to attract children in Egyptian rural areas to attend primary schools by providing them nutritious subsidized in-school meals as a contribution to breakfast consumption. The potential impact goal of targeting children through Food for Education programs (FFE) is to increase their educational achievement and subsequently improve their potential future efficiency and profit. This program includes governmental primary schools within all governorates of Egypt. The close link between nutritional deficiency and diminished cognitive performance and subsequently retarded educational accomplishment was the reason behind implementing nutritional feeding for Egyptian school-aged children to improve their health, cognitive performance, attention span, school attendance, and educational achievement.

Investments in nutrition and cognitive stimulation programs are thus the keys to optimizing child cognitive development and performance. From this perspective, our idea was generated - Relying on the consumption of biscuits that are based on natural ingredients (chickpeas \&, peanuts- for improving the cognitive function of children during the school days is much better than relying on drugs.

Both chickpeas and peanuts are types of legumes that are common in Egypt and the middle east. Egypt is a common source for chickpea production in the world where it is mostly consumed as whole seeds and several types of traditional food products. Both of them are overlooked as nutritious food although they have many health benefits as the more expensive nuts and must not be neglected.

These two beans although being nutritionally overachievers that deserve so much more, Yet, they're always moved down to the side-dish zone (e.g puréed of hummus). These two ingredients in addition to Wheat germ and Cinnamon could boost mental health improve mood, memory, cognitive stimulation, muscle control, and other nervous system and brain activities due to their vitamins, minerals, and chemical contents.

The objectives of the study:

to produce a fortified biscuit with chickpea and crushed peanut. To evaluate its effectiveness in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village after four months of daily intake of 3 biscuits per day for 4 months.

Specific aims To produce Chickpeas and Crushed peanut fortified biscuit To evaluate biscuit effect on short-term and working memory To evaluate biscuit effect on visual memory and the ability for categorization To evaluate biscuit effect on learning for speed of information processing, To evaluate biscuit effect on auditory attention ability with rising levels of difficulty.

Methodology:

Study design and Setting:

The study was a pilot community-based intervention that was conducted in El Othmanyia village of El Mahala district- Gharbyia governorate.

Phases of the study and tools:

This study was conducted in three phases that were done in a simultaneous way. The first phase included children recruitment and baseline assessment before intervention:

Assessment tools (Methods):

Anthropometric measurements of weight and height were carried out to exclude mal-nourished children. All measurements were made according to techniques described in the Anthropometric Standardization Reference Manual. Anthropometric measurements were taken during morning hours on empty stomach before having breakfast or a school meal, within a minimum of 8 hours after micturition and defecation, and after the morning exercises of spine stretching. All scores were calculated based on the WHO growth standards with the help of the Anthro-Program of PC.

Growth assessment according to WHO recommendations

1. Weight (in kg): by a Seca Scale Balance
2. Height (in cm): using Stadiometer
3. BMI (weight/Height2 in meter): calculated Dietary assessment: Detailed nutritional and dietary assessment using Diet Quality index assessment questionnaire, Food frequency pattern, and 24 hours questionnaires.

Cognitive performance assessment: Cognitive performance was assessed before and after the intervention by a battery of psychological tests that covered verbal \& non-verbal intelligence, memory, learning, and attention. The children were individually tested by trained researchers.

These tests are:

1. The Digit Span Test: The effect of the intake of the fortified biscuits with stimulation on short-term and working memory was tested by using the Digit Span Test: It is a subtest of the Revised Wechsler Intelligence Scale. The digit span memory task is a verbal measure of immediate memory and working memory maintenance and manipulation. Methodologically, digit span tasks have been proven to be both reliable and valid measures of working memory capacity. The Arabic version of the Revised Wechsler Intelligence Scale for children was used
2. Coding test: It is also a subtest of the Revised Wechsler Intelligence Scale for children. The children had to substitute symbols for numbers as quickly as possible. The score represents the total number of correct symbols written during a fixed time.
3. The auditory vigilance test: which measures the attention ability. It is a measure of the efficiency of identifying signal stimuli in the context of non-signal stimuli. The subjects were asked to pay attention while listening to many words from different categories like a key, ball, school, etc., and they were asked to give a sign, like raising their hands, when they hear certain words, chosen by the administrator. The scores of the test were calculated as total right and totally wrong.
4. The figural memory test: is a measure of free recall of visual objects. The subjects were shown a group of different photos like animals, cars, plants, etc., and they were asked to mention as many photos as they can.

Intervention phase 80 children of those who fulfilled the inclusion and the exclusion criteria were allocated randomly to either one of two groups (every 40 children),

1. The chickpea and crushed peanut biscuits dependent group received one daily pack of three fortified biscuits as snakes between breakfast and lunch on daily basis for four months.
2. The chickpea and crushed peanut biscuits non-dependent group received nothing
3. This supplement was accompanied by cognitive stimulation for both the two groups for the children and their parents (a monthly session with a total of 4 sessions for each)

Composition of the fortified biscuits:

The chickpeas and crushed peanuts fortified biscuit consisted of wheat flour (extract 72%), Chickpeas flour, crushed peanuts, wheat germ, Skimmed milk, corn oil, egg, sugar, Cinnamon, baking powder, salt, and vanilla. The first four constituents help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving the cognitive abilities of school-aged children.

Topics of stimulation sessions I. Sessions for mothers • Sessions for students

• 3. Post Intervention Evaluation Phase This phase included evaluation of the effect of consumption of the chickpea and crushed peanut biscuits on the improvement of the cognitive abilities

Eligibility criteria: Inclusion Criteria:

* apparently healthy prepubescent boys and girls in the primary schools with four grades.
* Children should not skip breakfast,
* the number of daily meals (at least 3 times per day),
* does not eat any school snack meal during the school day (other than the biscuits under the study for the fortified biscuits dependent group).

Exclusion Criteria:

* any mental disorder,
* chronic disease,
* visual or auditory impairment, Any malnourished child as detected by both the anthropometric measures and by the Nutritional Status Assessment questionnaire

Primary outcomes:
measure: Production of Chickpeas and Crushed peanut fortified biscuit
timeFrame: three months after the initiation of the study
measure: Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
timeFrame: 4 months after the initiation of the intervention
measure: Mean change of scaled score of the figural memory test as a measure of visual memory to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
timeFrame: 4 months after the initiation of the intervention
measure: Mean change of scaled score of auditory vigilance tests A and B Test as a measure of auditory attention ability with rising levels of difficulty to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
timeFrame: 4 months after the initiation of the intervention
measure: Mean change of scaled score of the Coding test as a measure of improved visual-motor coordination, visual encoding, and speed of information processing to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
timeFrame: 4 months after the initiation of the intervention
measure: Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the fortified biscuits' effect compared to before fortification
timeFrame: 4 months after the initiation of the intervention
measure: Mean change of scaled score of the figural memory test as a measure of visual memory to detect the fortified biscuits' effect compared to before fortification
timeFrame: 4 months after the initiation of the intervention
measure: Mean change of scaled score of auditory vigilance tests A and B Test as a measure of auditory attention ability with rising levels of difficulty to detect the fortified biscuits' effect compared to before fortification
timeFrame: 4 months after the initiation of the intervention
measure: Mean change of scaled score of the Coding test as a measure of improved visual-motor coordination, visual encoding, and speed of information processing to detect the fortified biscuits' effect compared to before fortification
timeFrame: 4 months after the initiation of the intervention
Secondary outcomes:
measure: Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
timeFrame: 4 months after the initiation of the intervention
measure: Mean change of scaled score of the figural memory test as a measure of visual memory to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
timeFrame: 4 months after the initiation of the intervention
measure: Change of mean scaled score of Cognitive stimulation ability to improve auditory attention ability with rising levels of difficulty to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
timeFrame: 4 months after the initiation of the intervention
measure: Change of mean scaled score of Cognitive stimulation ability to improve learning for speed of information processing to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
timeFrame: 4 months after the initiation of the intervention
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: National Research Centre
state: Al Jizah
Study officials:
affiliation: National Research Centre of Egypt
name: Ammal M Metwally, PhD (MD)
role: PRINCIPAL_INVESTIGATOR
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