Evidence map›Paper›PMID 36647110›Full record

ArticleTrials2023

Comparison of the effect of modified intermittent fasting and daily calorie restriction on sleep quality, anthropometric data, and body composition in women with obesity or overweight: study protocol of a randomized controlled trial.

Saeedeh Hosseini Hooshiar, Akram Yazdani, Sadegh Jafarnejad

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Saeedeh Hosseini HooshiarResearch Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran.
Akram YazdaniDepartment of Biostatistics and Epidemiology, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran.
Sadegh JafarnejadResearch Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran. sjafarnejad@alumnus.tums.ac.ir.ORCID http://orcid.org/0000-0001-6121-8837
Kashan University of Medical Sciences · IR

Funding

Kashan University of Medical Sciences 64510
6 · The paper itself

Abstract

backgroundSleep disturbances are common in nearly one-third of adults. Both low quality of sleep and sleep time could be related to increased obesity. An increase in visceral adipose tissue can result in the secretion of inflammatory cytokines. Inflammatory cytokines can lead to a disturbance of the sleep-wake rhythm. Therefore, weight loss may improve sleep quality and duration. Intermittent fasting diet as a popular diet reduces body weight and improves anthropometric indices. This study is performed to further investigate the effect of a modified intermittent fasting diet on sleep quality and anthropometric indices.

methodsThis is an open-label randomized controlled trial to evaluate the effect of daily calorie restriction (control) and modified intermittent fasting (intervention) on sleep quality, anthropometric data, and body composition in women with obesity or overweight for 8 weeks. Fifty-six participants will be classified using stratified randomization based on body mass index (BMI) and age. Then, participants will be assigned to one of the two groups of intervention or control using the random numbers table. The sleep quality, daytime sleepiness, and insomnia will be evaluated by using the Pittsburgh Sleep Quality Index (PSQI), the Epworth Sleepiness Scale (ESS), and the Insomnia Severity Index respectively. The primary outcomes chosen for the study were as follows: the difference in sleep quality, daytime sleepiness, insomnia, BMI, fat-free mass (FFM), body fat mass, waist circumference, and waist-to-hip ratio from baseline to 8 weeks. Secondary outcomes chosen for the study were as follows: the difference in hip circumference, the visceral fat area, percent body fat, soft lean mass, skeletal muscle mass, extracellular water ratio, and total body water from baseline to 8 weeks. DISCUSSION: This study will investigate the effect of intermittent fasting intervention compared with daily calorie restriction on sleep quality and anthropometric indices. The information gained will enhance our understanding of fasting interventions, which can be used to improve clinical dietary recommendations. The findings will help to disclose as yet the unknown relationship between diet and sleep quality.

trial registrationIranian Registry of Clinical Trials IRCT20220522054958N3. Registered on 8 July 2022. https://www.irct.ir/trial/64510 .

Indexed as

Disorders of Excessive SomnolenceSleep Initiation and Maintenance DisordersAdultBody CompositionBody Mass IndexCaloric RestrictionFemaleHumansIntermittent FastingIranObesityOverweightRandomized Controlled Trials as TopicSleep QualityAnthropometric indicesIntermittent fastingPittsburgh Sleep Quality IndexSleep qualityWeight loss

Identifiers

PMID36647110
PMCPMC9843895
OpenAlexW4316657451

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.