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The effect of a ketogenic diet versus a high-carbohydrate, low-fat diet on sleep, cognition, thyroid function, and cardiovascular health independent of weight loss: study protocol for a randomized controlled trial.

Trials
January 23, 2018
Stella Iacovides et al. (2 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the effects of a high-carbohydrate, low-fat diet versus a ketogenic diet on sleep, thyroid function, cognition, and cardio-metabolic health in healthy adults, independent of weight loss.

Results Summary

The abstract does not provide specific results for the low-fat diet, as the study appears to be in progress or not yet concluded.

Population

Healthy men and women aged 18-50 years.

Effective Dosage

55% carbohydrates, 20% fat, 25% protein (isocaloric diet).

Duration

Minimum of 3 weeks per dietary intervention.

Interactions

None mentioned

Extracted Claims (15)
InterventionDirectionEndpointPopulationDosageImpactClaim #
ketogenic diet (KD)
neutral
sleep
healthy adults
-
determine the effects
#1
ketogenic diet (KD)
neutral
thyroid function
healthy adults
-
determine the effects
#2
ketogenic diet (KD)
neutral
cognition
healthy adults
-
determine the effects
#3
ketogenic diet (KD)
neutral
cardio-metabolic health
healthy adults
-
determine the effects
#4
ketogenic diet (KD)
neutral
basal metabolic rate
healthy adults
-
determine whether a change in basal metabolic rate may be associated with any changes observed
#5
high-carbohydrate, low-fat diet (55% CHO, 20% fat, 25% protein)
neutral
-
Twenty healthy men and women between 18 and 50 years of age
-
will follow
#6
ketogenic diet (KD) (15% CHO, 60% fat, 25% protein)
neutral
-
Twenty healthy men and women between 18 and 50 years of age
-
will follow
#7
ketogenic diet (KD)
neutral
sleep quality
participants
-
assessed for
#8
ketogenic diet (KD)
neutral
cognitive function
participants
-
assessed for
#9
ketogenic diet (KD)
neutral
thyroid function
participants
-
assessed for
#10
ketogenic diet (KD)
neutral
basal metabolic rate
participants
-
assessed for
#11
ketogenic diet (KD)
neutral
cardio-metabolic markers
participants
-
measurement of
#12
ketogenic diet (KD)
neutral
immune markers
participants
-
measurement of
#13
ketogenic diet (KD)
neutral
aspects of physiological health
healthy adults
-
understanding the potential effects
#14
ketogenic diet (KD)
neutral
physiological health
healthy population
-
explore whether diet-related metabolic changes may be responsible for the changes observed
#15
Abstract

BACKGROUND: Many physiological health benefits observed after following a ketogenic diet (KD) can be attributed to the associated weight loss. The KD has become more prominent as a popular health choice, not only in obese/overweight individuals, but also in healthy adults. The study aims to determine the effects of a KD, independent of weight loss, on various aspects of physiological health including: sleep, thyroid function, cognition, and cardio-metabolic health. The study will also aim to determine whether a change in basal metabolic rate may be associated with any changes observed. METHODS: Twenty healthy men and women between 18 and 50 years of age will take part in this study. In a randomized controlled, cross-over design, participants will follow two isocaloric diets: a high-carbohydrate, low-fat diet (55% CHO, 20% fat, 25% protein) and a KD (15% CHO, 60% fat, 25% protein). Each dietary intervention will last for a minimum of 3 weeks, with a 1-week washout period in between. Before and after each diet, participants will be assessed for sleep quality, cognitive function, thyroid function, and basal metabolic rate. A blood sample will also be taken for the measurement of cardio-metabolic and immune markers. DISCUSSION: The present study will help in understanding the potential effects of a KD on aspects of physiological health in healthy adults, without the confounding factor of weight loss. The study aims to fill a significant void in the academic literature with regards to the benefits and/or risks of a KD in a healthy population, but will also explore whether diet-related metabolic changes may be responsible for the changes observed in physiological health. TRIAL REGISTRATION: Pan African Clinical Trial Registry ( www.pactr.org ), trial number: PACTR201707002406306 . Registered on 20 July 2017.

Medical Subject Headings (MeSH)
AdolescentAdultBiomarkersCardiovascular DiseasesCognitionCross-Over StudiesDiet, Fat-RestrictedDiet, KetogenicDietary CarbohydratesEnergy IntakeEnergy MetabolismFemaleHealth StatusHealthy VolunteersHumansMaleMiddle AgedProtective FactorsRandomized Controlled Trials as TopicRisk FactorsSleepSouth AfricaThyroid GlandTime FactorsTreatment OutcomeYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Quality85/10
Citation Metrics
Total Citations23
Citations/Year3.3
Relative Citation Ratio1.30
NIH Percentile60%
Research Impact Scores
APT Score0.75
Weight Score2.23
Normalized Score0.57
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