NCT03755674

Brief Summary

BACKGROUND: Several reports have observed that the alteration of normal biological rhythms is associated with obesity development. In this regard, those subject with the preference for evening seems to be prone to develop obesity. However, the current treatment of obesity does not take into account these aspects OBJECTIVE: To evaluate whether a diet adjusted to patient's chronotype is more effective than the current dietary recommendations. SUBJECTS/METHODS: 209 subjects take part in a randomized, double-blind clinical trial. 104 subjects followed a typical hypocaloric dietary treatment (CONTROL) and the other 105 subjects undergone a diet with a daily caloric distribution adjusted to their chronotype (CHRONO). CONCLUSIONS: A chronotype-adjusted diet may be a promising alternative to the classical hypocaloric dietary treatment since the investigator's data indicate a higher effectiveness regarding weight loss when the diet was adjusted to the patient's chronotype.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

1.9 years

First QC Date

July 19, 2018

Last Update Submit

November 25, 2018

Conditions

Obesity

Keywords

ObesityAppetite regulationChronotypeDiet

Outcome Measures

Primary Outcomes (1)

  • Total weight loss, in percentage, from baseline to end-of-treatment

    Percentage of weight loss, measured with a scale, from baseline weight (100% body weight) since body weight after 12 weeks of treatment (final body weight). Percentage of body weight was then measured as Total Weight Loss (%) = (Final body weight - Baseline body weight) / baseline body weight x 100.

    12 weeks

Secondary Outcomes (2)

  • BMI loss

    12 weeks

  • Anthropometrical and other clinical parameters

    12 weeks

Study Arms (2)

CHRONOTYPE-ADJUSTED DIET

EXPERIMENTAL

Patients that undergo a chronotype adjusted diet

Procedure: CHRONOTYPE-ADJUSTED DIET

CONTROL

NO INTERVENTION

Patients following a traditional or conventional hypocaloric diet

Interventions

CHRONOTYPE-ADJUSTED DIETPROCEDURE

Those patients followed a daily caloric distribution attending to their chronotype. In this regards, 'morning' subjects ate a higher quantity of calories at the first part of the day, while 'evening' subjects ate a higher amount of calories at the second half of the day.

CHRONOTYPE-ADJUSTED DIET

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • students or staff of the Catholic University of Murcia (UCAM), with an age ranged between 18 and 65 years old

You may not qualify if:

  • clinically significant illnesses (including type 2 diabetes, chronic heart failure, hepatitis and cancer)
  • those taking any medications known to affect body weight (thyroid hormones, corticosteroids, etc.)
  • women in special physiological situations (pregnant, lactating).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Galindo Munoz JS, Gomez Gallego M, Diaz Soler I, Barbera Ortega MC, Martinez Caceres CM, Hernandez Morante JJ. Effect of a chronotype-adjusted diet on weight loss effectiveness: A randomized clinical trial. Clin Nutr. 2020 Apr;39(4):1041-1048. doi: 10.1016/j.clnu.2019.05.012. Epub 2019 May 21.

    PMID: 31153674DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Juan José Hernández Morante, PhD

    Universidad Católica San Antonio de Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of Eating Disorders Research Unit

Study Record Dates

First Submitted

July 19, 2018

First Posted

November 28, 2018

Study Start

January 10, 2015

Primary Completion

December 21, 2016

Study Completion

February 23, 2017

Last Updated

November 28, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share