Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program

NCT03120260 | Completed DMC

• 1 other identifier: ND-201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to evaluate the effect of sleep duration on weight loss of obese and overweight adult when they are in a weight loss plan (NovinDiet Protocol). The investigators aim is to compare the effects of short term sleep duration with normal sleep duration with respect to body weight (and abdominal adiposity).

Conditions

Obesity; Overweight

Keywords

Caloric Restriction; weight loss; sleep

Outcome Measures

Primary Outcomes (1)

• weight loss

  kg

  12 Weeks

Secondary Outcomes (5)

• Body mass index reduction

  12 Weeks

• Fasting plasma glucose level

  12 Weeks

• lipid profiles

  12 Weeks

• Insulin resistance (HOMA)

  12 Weeks

• liver enzymes (SGOT, SGPT)

  12 Weeks

Study Arms (2)

Short Sleep

EXPERIMENTAL

Diet+ have 5 hour sleep at night (SS)

Other: Diet

Normal Sleep

EXPERIMENTAL

Diet+ have 7-8 hour sleep at night (NS)

Other: Diet

Interventions

Diet OTHER

Intervention 'Diet+ short sleep versus normal sleep

Normal Sleep; Short Sleep

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be female
• Must have \< 7 hour sleep per night
• Must be 18-45 years of age.
• Must have Body mass index (BMI) between 27-35 kg/ m².
• Must be able to have moderate exercise.
• Must be interested to have weight loss.

You may not qualify if:

• Participating in a research project involving weight loss or physical activity in the previous six months.
• Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
• Taking medication that could affect metabolism or change body weight.
• Report heart problems, chest pain, and cancer within the last five years.
• Smoking
• Menopause
• Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Sponsors & Collaborators

• Novindiet Clinic: lead
• University of Nottingham: collaborator
• Tehran University of Medical Sciences: collaborator

Study Sites (1)

NovinDiet Clinic

Tehran, Iran

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Interventions

Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2017
• First Posted: April 19, 2017
• Study Start: June 15, 2017
• Primary Completion: October 2, 2017
• Study Completion: November 27, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

IR (1)