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OpenTrials
Completed

NCT Number: NCT03755674

CHRONOtype-adjusted DIET on Weight Loss

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CHRONOTYPE-ADJUSTED DIET

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. BMI loss

    Time frame: 12 weeks

    BMI decrease from baseline

  2. Anthropometrical and other clinical parameters

    Time frame: 12 weeks

    Improvement of anthropometrical and other clinical parameters during the treatment

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Collaborators

  • Hospital Universitario Virgen de la Arrixaca

Registry information

Official study title

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

Acronym: CHRONO-DIET

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 28, 2018
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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