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Effects of Moderate Consumption of Lean Fish on Weight Loss

Primary Purpose

Obesity, Overweight

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Fish group

Control group

About this trial

This is an interventional treatment trial for Obesity focused on measuring lean fish, weight loss, Diet

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

NovinDiet Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Fish group

Control group

Arm Description

subjects will have 3 x 150 g lean fish/ week at main meal

subjects will have no seafood.

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

waist circumference

fasting plasma glucose

mmol/l

serum insulin level

mU/l

insulin resistance (HOMA-IR)

score

glycosylated hemoglobin (HbA1c)

percentage (%)

lipid profiles

mmol/l

liver enzymes (SGOT, SGPT)

U/l

Full Information

NCT ID

NCT03120429

First Posted

April 15, 2017

Last Updated

October 24, 2019

Sponsor

Novindiet Clinic

Collaborators

University of Nottingham, Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03120429

Brief Title

Effects of Moderate Consumption of Lean Fish on Weight Loss

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 25, 2017 (Actual)

Primary Completion Date

January 22, 2019 (Actual)

Study Completion Date

October 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novindiet Clinic

Collaborators

University of Nottingham, Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight

Keywords

lean fish, weight loss, Diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fish group

Arm Type

Experimental

Arm Description

subjects will have 3 x 150 g lean fish/ week at main meal

Arm Title

Control group

Arm Type

Experimental

Arm Description

subjects will have no seafood.

Intervention Type

Behavioral

Intervention Name(s)

Fish group

Other Intervention Name(s)

Intervention Description

Fish group will have hypoenergetic diet in which subjects will have 3 x 150 g lean fish/ week at main meal

Intervention Type

Behavioral

Intervention Name(s)

Control group

Other Intervention Name(s)

Intervention Description

Control group will have hypo-energetic diet in which subjects have no seafood.

Primary Outcome Measure Information:

Title

weight loss

Description

Time Frame

24 Weeks

Secondary Outcome Measure Information:

Title

waist circumference

Description

Time Frame

24 Weeks

Title

fasting plasma glucose

Description

mmol/l

Time Frame

24 Weeks

Title

serum insulin level

Description

mU/l

Time Frame

24 Weeks

Title

insulin resistance (HOMA-IR)

Description

score

Time Frame

24 Weeks

Title

glycosylated hemoglobin (HbA1c)

Description

percentage (%)

Time Frame

24 Weeks

Title

lipid profiles

Description

mmol/l

Time Frame

24 Weeks

Title

liver enzymes (SGOT, SGPT)

Description

U/l

Time Frame

24 Weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

NovinDiet Clinic

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Effects of Moderate Consumption of Lean Fish on Weight Loss

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