CHRONOtype-adjusted DIET on Weight Loss (CHRONO-DIET)

November 25, 2018 updated by: Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia

Influence of Chronobiological and Neuroendocrine Factors in Appetite Regulation and Obesity Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CHRONOTYPE-ADJUSTED DIET
Patients that undergo a chronotype adjusted diet
Procedure: CHRONOTYPE-ADJUSTED DIET
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.
NO_INTERVENTION: CONTROL
Patients following a traditional or conventional hypocaloric diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total weight loss, in percentage, from baseline to end-of-treatment
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI loss
Time Frame: 12 weeks
BMI decrease from baseline
12 weeks
Anthropometrical and other clinical parameters
Time Frame: 12 weeks
Improvement of anthropometrical and other clinical parameters during the treatment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica San Antonio de Murcia

Collaborators

Hospital Universitario Virgen de la Arrixaca

Investigators

  • Principal Investigator: Juan José Hernández Morante, PhD, Universidad Católica San Antonio de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2015

Primary Completion (ACTUAL)

December 21, 2016

Study Completion (ACTUAL)

February 23, 2017

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

November 25, 2018

First Posted (ACTUAL)

November 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 25, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMAFI14/12-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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