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CompletedNCT03120429Updated Oct 25, 2019

Effects of Moderate Consumption of Lean Fish on Weight Loss

An interventional study of Fish group and Control group in Obesity and Overweight, sponsored by Novindiet Clinic. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-25.

Sponsored by Novindiet Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight

Keywords

  • lean fish
  • weight loss
  • Diet
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's enrollment of 120 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Novindiet Clinic is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Fish group

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

    Behavioral: Fish group

  • Experimental
    Control group

    subjects will have no seafood.

    Behavioral: Control group

Interventions

  • BehavioralFish group

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

    Also known as: FG

  • BehavioralControl group

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

    Also known as: CG

06

What researchers measure

Primary outcomes

  1. weight loss

    kg

    Time frame: 24 Weeks

Secondary outcomes

  1. waist circumference

    cm

    Time frame: 24 Weeks

  2. fasting plasma glucose

    mmol/l

    Time frame: 24 Weeks

  3. serum insulin level

    mU/l

    Time frame: 24 Weeks

  4. insulin resistance (HOMA-IR)

    score

    Time frame: 24 Weeks

  5. glycosylated hemoglobin (HbA1c)

    percentage (%)

    Time frame: 24 Weeks

  6. lipid profiles

    mmol/l

    Time frame: 24 Weeks

  7. liver enzymes (SGOT, SGPT)

    U/l

    Time frame: 24 Weeks

07

Study locations

1 site
  • NovinDiet Clinic
    Tehran, Iran, Islamic Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03120429
Lead sponsor
Novindiet Clinic
Collaborators
University of Nottingham, Tehran University of Medical Sciences
Responsible party
Sponsor
First posted
Apr 19, 2017
Start date
Jun 25, 2017
Primary completion
Jan 22, 2019
Completion
Oct 13, 2019
Last update
Oct 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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