Effects of Moderate Consumption of Lean Fish on Weight Loss

Obesity Clinical Trial

Official title:

Effects of Moderate Consumption Lean Fish on Weight Loss of Overweight and Obese Women During a Weight Loss Program, a 24 Week Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120429
• Other study ID #: ND-203
• Status: Completed
• Phase: N/A
• Start date: June 25, 2017
• Est. completion date: October 13, 2019

Study information

• Verified date: October 2019
• Source: Novindiet Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the aim of present study is to compare the specific effects moderate consumption of lean fish on weight loss of healthy obese and overweight female adults, while participants follow energy-restricted diets also to investigate the effects of this intervention on carbohydrate and lipid profiles, as cardiometabolic risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 13, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• female

• 18-45 years of age.

• Body mass index (BMI) between 27.5-35 kg/m²

• Must be able to have moderate exercise.

• Must be interested to lose weight

Exclusion Criteria:

• Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.

• Taking medications that could affect metabolism or change body weight.

• Report heart problems, chest pain, and cancer within the last five years.

• Use of supplements containing n-3 fatty acids, calcium or vitamin-D during the last 3 months.

• Consumption of fish and sea foods regularly

• Smoking

• Menopause

• Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Fish group
Fish group will have hypoenergetic diet in which subjects will have 3 x 150 g lean fish/ week at main meal
• Control group
Control group will have hypo-energetic diet in which subjects have no seafood.

Locations

Country	Name	City	State
Iran, Islamic Republic of	NovinDiet Clinic	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Novindiet Clinic	Tehran University of Medical Sciences, University of Nottingham

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	kg	24 Weeks
Secondary	waist circumference	cm	24 Weeks
Secondary	fasting plasma glucose	mmol/l	24 Weeks
Secondary	serum insulin level	mU/l	24 Weeks
Secondary	insulin resistance (HOMA-IR)	score	24 Weeks
Secondary	glycosylated hemoglobin (HbA1c)	percentage (%)	24 Weeks
Secondary	lipid profiles	mmol/l	24 Weeks
Secondary	liver enzymes (SGOT, SGPT)	U/l	24 Weeks