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Completed

NCT Number: NCT03120429

Effects of Moderate Consumption of Lean Fish on Weight Loss

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NovinDiet Clinic

Tehran, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fish group

Behavioral

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

Other names: FG

Control Group

Behavioral

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

Other names: CG

Primary outcomes

  1. weight loss

    Time frame: 24 Weeks

    kg

Secondary outcomes

  1. waist circumference

    Time frame: 24 Weeks

    cm

  2. fasting plasma glucose

    Time frame: 24 Weeks

    mmol/l

  3. serum insulin level

    Time frame: 24 Weeks

    mU/l

  4. insulin resistance (HOMA-IR)

    Time frame: 24 Weeks

    score

  5. glycosylated hemoglobin (HbA1c)

    Time frame: 24 Weeks

    percentage (%)

  6. lipid profiles

    Time frame: 24 Weeks

    mmol/l

  7. liver enzymes (SGOT, SGPT)

    Time frame: 24 Weeks

    U/l

Sponsors and collaborators

Lead sponsor

Novindiet Clinic

Other

Collaborators

  • Tehran University of Medical Sciences
  • University of Nottingham

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2017
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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