ObesityNCT03120429
Effects of Moderate Consumption of Lean Fish on Weight Loss
A study testing Fish group in people with Obesity and Overweight, run by Novindiet Clinic at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Fish group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- 25 Jun 2017to 13 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Obesity, Overweight
- Being tested
- Fish group, Control group
- Keywords
- lean fish, weight loss, Diet
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish groupBehavioural
Also called FG
Fish group will have hypoenergetic diet in which subjects will have 3 x 150 g lean fish/ week at main meal
Control groupBehavioural
Also called CG
Control group will have hypo-energetic diet in which subjects have no seafood.
| Study group | Role | What they receive |
|---|---|---|
| Fish group | Experimental | subjects will have 3 x 150 g lean fish/ week at main meal Receives: Behavioral: Fish group |
| Control group | Experimental | subjects will have no seafood. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
kg
Measured: 24 Weeks
Secondary outcomes (7)
waist circumference
cm
Measured: 24 Weeks
fasting plasma glucose
mmol/l
Measured: 24 Weeks
serum insulin level
mU/l
Measured: 24 Weeks
insulin resistance (HOMA-IR)
score
Measured: 24 Weeks
glycosylated hemoglobin (HbA1c)
percentage (%)
Measured: 24 Weeks
lipid profiles
mmol/l
Measured: 24 Weeks
liver enzymes (SGOT, SGPT)
U/l
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start25 Jun 2017
- Primary completion22 Jan 2019
- Study completion13 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novindiet Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Tehran University of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120429
- Sponsor's protocol ID
- ND-203
- Status last verified
- Oct 2019
- First submitted
- 15 Apr 2017
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03120429
- Acronym / sponsor ID
- ND-203
- Conditions
- Obesity, Overweight
- Keywords
- lean fish, weight loss, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Novindiet ClinicUniversity, hospital or other
- Collaborators
- University of Nottingham, Tehran University of Medical Sciences
- Study start
- 25 Jun 2017 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 13 Oct 2019 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish group | Experimental | Behavioral: Fish groupsubjects will have 3 x 150 g lean fish/ week at main meal |
| Control group | Experimental | Behavioral: Control groupsubjects will have no seafood. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish groupAlso: FGFish group will have hypoenergetic diet in which subjects will have 3 x 150 g lean fish/ week at main meal | Behavioural | Fish group |
| Control groupAlso: CGControl group will have hypo-energetic diet in which subjects have no seafood. | Behavioural | Control group |
Primary outcome
weight loss
Time frame: 24 Weeks
kg
7 secondary outcomes
waist circumference
Time frame: 24 Weeks
fasting plasma glucose
Time frame: 24 Weeks
serum insulin level
Time frame: 24 Weeks
insulin resistance (HOMA-IR)
Time frame: 24 Weeks
glycosylated hemoglobin (HbA1c)
Time frame: 24 Weeks
lipid profiles
Time frame: 24 Weeks
liver enzymes (SGOT, SGPT)
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish group in people with Obesity and Overweight, run by Novindiet Clinic at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.