Effects of Moderate Consumption of Lean Fish on Weight Loss

October 24, 2019 updated by: Novindiet Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

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: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fish group
subjects will have 3 x 150 g lean fish/ week at main meal
Behavioral: Fish group
Fish group will have hypoenergetic diet in which subjects will have 3 x 150 g lean fish/ week at main meal
Other Names:
  • FG
EXPERIMENTAL: Control group
subjects will have no seafood.
Behavioral: Control group
Control group will have hypo-energetic diet in which subjects have no seafood.
Other Names:
  • CG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: 24 Weeks
kg
24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
waist circumference
Time Frame: 24 Weeks
cm
24 Weeks
fasting plasma glucose
Time Frame: 24 Weeks
mmol/l
24 Weeks
serum insulin level
Time Frame: 24 Weeks
mU/l
24 Weeks
insulin resistance (HOMA-IR)
Time Frame: 24 Weeks
score
24 Weeks
glycosylated hemoglobin (HbA1c)
Time Frame: 24 Weeks
percentage (%)
24 Weeks
lipid profiles
Time Frame: 24 Weeks
mmol/l
24 Weeks
liver enzymes (SGOT, SGPT)
Time Frame: 24 Weeks
U/l
24 Weeks

Collaborators and Investigators

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

Sponsor

Novindiet Clinic

Collaborators

Tehran University of Medical Sciences
University of Nottingham

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)

June 25, 2017

Primary Completion (ACTUAL)

January 22, 2019

Study Completion (ACTUAL)

October 13, 2019

Study Registration Dates

First Submitted

April 15, 2017

First Submitted That Met QC Criteria

April 15, 2017

First Posted (ACTUAL)

April 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ND-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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