The Effects of an Evening Snack of Walnuts on Diet and Sleep Quality in Adolescents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorPenn State University
About this trial
The goal of this study is to examine whether an evening snack of 1 oz of walnuts consumed in place of usual evening snacks for 4 weeks has a beneficial effect on diet quality and sleep quality in adolescents age 13-17 years.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 13 to 17 years
Enrolled in school (secondary education) that has defined start and end times (i.e., traditional in-person school or home/virtual school with a consistent schedule)
Consumes snacks in the evening (between dinner and sleep) on most nights
Able to read and answer questions in English
Disqualifiers
Sleep disorder (e.g., insomnia, sleep disordered breathing, narcolepsy)
Developmental disorder (e.g., autism, intellectual disability, developmental delay)
Diabetes
Any other medical condition impacting sleep or diet
Trial design
Design model
Crossover
Treatments tested in this trial
Walnuts
Other interventionParticipants will replace their usual evening snack(s) with 1 oz of walnuts each evening for 4 weeks.
Control (usual diet)
Other interventionParticipants will maintain their usual snacking behavior/diet
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Walnut then ControlOther 2 interventions
Group B: Control then WalnutOther 2 interventions
Trial outcomes
Primary outcomes
1
Health Eating Index score
Healthy Eating Index will be calculated from 24-hour recalls completed using the NIH ASA-24 system. The effect of the intervention will be determined as the difference of baseline-post change for the walnut intervention period and the baseline-post change for the habitual snack control period.
Time frame
Baseline and end of 4 week study period for both the walnut intervention and the habitual snack control period (4 time points total)2
Sleep maintenance efficiency
Sleep maintenance efficiency is a metric of sleep quality that is defined as the percentage of the overnight sleep interval that is spent actually asleep. Sleep maintenance efficiency will be measured using wrist actigraphy over 2-week periods at baseline and post-intervention for both the walnut intervention period and habitual snack control period. The effect of the intervention will be defined as the difference of baseline-post change for the walnut intervention period and the baseline-post change for the habitual snack control period.
Time frame
Two-week measurement bursts immediately prior to and end at the end of 4-week study period for both the walnut intervention and the habitual snack control period (4 time points/8 weeks total)Secondary outcomes
1
Healthy Eating Index - Seafood & Plant Protein component score
Healthy Eating Index (HEI) Seafood \& Plant Protein component score will be calculated from 24-hour recalls completed using the NIH ASA-24 system. The effect of the intervention will be determined as the difference of baseline-post change for the walnut intervention period and the baseline-post change for the habitual snack control period.
Time frame
Baseline and end of 4 week study period for both the walnut intervention and the habitual snack control period (4 time points total)2
Healthy Eating Index - Fatty Acid component score
Healthy Eating Index (HEI) Fatty Acid will be calculated from 24-hour recalls completed using the NIH ASA-24 system. The effect of the intervention will be determined as the difference of baseline-post change for the walnut intervention period and the baseline-post change for the habitual snack control period.
Time frame
Baseline and end of 4 week study period for both the walnut intervention and the habitual snack control period (4 time points total)3
Healthy Eating Index - Sodium component score
Healthy Eating Index - Sodium component score will be calculated from 24-hour recalls completed using the NIH ASA-24 system. The effect of the intervention will be determined as the difference of baseline-post change for the walnut intervention period and the baseline-post change for the habitual snack control period
Time frame
Baseline and end of 4 week study period for both the walnut intervention and the habitual snack control period (4 time points total)4
Healthy Eating Index - Refined Grains component score
Healthy Eating Index - Refined Grains component score will be calculated from 24-hour recalls completed using the NIH ASA-24 system. The effect of the intervention will be determined as the difference of baseline-post change for the walnut intervention period and the baseline-post change for the habitual snack control period
Time frame
Baseline and end of 4 week study period for both the walnut intervention and the habitual snack control period (4 time points total)Other outcomes
1
Sleep timing
Sleep onset, midpoint, and offset will be measured using wrist actigraphy over 2-week periods at baseline and post-intervention for both the walnut intervention period and habitual snack control period. The effect of the intervention will be defined as the difference of baseline-post change for the walnut intervention period and the baseline-post change for the habitual snack control period.
Time frame
Two-week measurement bursts immediately prior to and end at the end of 4-week study period for both the walnut intervention and the habitual snack control period (4 time points/8 weeks total)2
Variability of sleep maintenance efficiency
Individual standard deviation of nightly sleep maintenance efficiency during each 2-week measurement burst. This is a metric of within-individual variability of sleep quality. The effect of the intervention will be defined as the difference of baseline-post change for the walnut intervention period and the baseline-post change for the habitual snack control period.
Time frame
Two-week measurement bursts immediately prior to and end at the end of 4-week study period for both the walnut intervention and the habitual snack control period (4 time points/8 weeks total)3
Variability of sleep duration
Individual standard deviation of nightly sleep duration during each 2-week measurement burst. This is a metric of within-individual variability of sleep duration. The effect of the intervention will be defined as the difference of baseline-post change for the walnut intervention period and the baseline-post change for the habitual snack control period.
Time frame
Two-week measurement bursts immediately prior to and end at the end of 4-week study period for both the walnut intervention and the habitual snack control period (4 time points/8 weeks total)4
Variability of sleep timing
Individual standard deviation of sleep onset, midpoint, and offset during each 2-week measurement burst. This is a metric of within-individual variability of sleep timing. The effect of the intervention will be defined as the difference of baseline-post change for the walnut intervention period and the baseline-post change for the habitual snack control period.
Time frame
Two-week measurement bursts immediately prior to and end at the end of 4-week study period for both the walnut intervention and the habitual snack control period (4 time points/8 weeks total)Sponsors and contacts
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Source ClinicalTrials.gov
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