Effects of Moderate Consumption of Lean Fish on Weight Loss
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jun 2017
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedStudy Start
First participant enrolled
June 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2019
CompletedOctober 25, 2019
October 1, 2019
1.6 years
April 15, 2017
October 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight loss
kg
24 Weeks
Secondary Outcomes (7)
waist circumference
24 Weeks
fasting plasma glucose
24 Weeks
serum insulin level
24 Weeks
insulin resistance (HOMA-IR)
24 Weeks
glycosylated hemoglobin (HbA1c)
24 Weeks
- +2 more secondary outcomes
Study Arms (2)
Fish group
EXPERIMENTALsubjects will have 3 x 150 g lean fish/ week at main meal
Control group
EXPERIMENTALsubjects will have no seafood.
Interventions
Fish group will have hypoenergetic diet in which subjects will have 3 x 150 g lean fish/ week at main meal
Control group will have hypo-energetic diet in which subjects have no seafood.
Eligibility Criteria
You may qualify if:
- female
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novindiet Cliniclead
- University of Nottinghamcollaborator
- Tehran University of Medical Sciencescollaborator
Study Sites (1)
NovinDiet Clinic
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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 25, 2017
Primary Completion
January 22, 2019
Study Completion
October 13, 2019
Last Updated
October 25, 2019
Record last verified: 2019-10