ObesityNCT03348566
Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Changes
An observational study of Obesity, run by Harvard School of Public Health (HSPH).
Trial summary
the investigators tested whether genetic variants near FADS cluster, which were recently identified to be signatures of adaptation to fish- and n-3 PUFAs-rich diet, interacted with these dietary factors on long-term change of body mass index (BMI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- What is being tested?
- fish
- How many people
- 22,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 1 Mar 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Nurses' Health Study began in 1976, when 121,700 female registered nurses aged 30-55 y were recruited to complete a baseline questionnaire. the investigators included 11,323 women of European ancestry. Informed consent was obtained from all participants. The Health Professionals Follow-up Study The HPFS was initiated in 1986, and was composed of 51,529 male aged 40-75 y at baseline. This study included 6,833 men whose genotype data were available. Informed consent was obtained from all participants. The Women's Health Initiative (WHI) is a large, multiethnic, 40-center study that focuses on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. 6,254 Caucasians women with European ancestry were included. The design of Singapore Chinese Health Study (SCHS): Between 1993 and 1998, 63,257 Chinese between 45 and 74 in Singapore were enrolled. 5,264 subjects with genotyping data were included in this analysis.
Who may be able to join
- 11,323 women of European ancestry.
- Informed consent was obtained from all participants. The DNA extraction methods, quality control measures,
- SNPs genotyping and imputation data are available .
- Both cases and controls with genotyping data are available based on GWASs
Who cannot join
- participants without genetic data
About this study
Official title: Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Change
the investigators tested whether genetic variants near FADS cluster, which were recently identified to be signatures of adaptation to fish- and n-3 PUFAs-rich diet, interacted with these dietary factors on long-term change of body mass index (BMI).
- Conditions
- Obesity
- Being tested
- fish
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fishOther
fish intkae
What is being measured
The primary outcome is the main question the study is designed to answer.
weight changes
long term weight changes: this study measured body weight at baseline (1990) and follow up body weight in 2000. The long term body weight was defined as changes from baseline to follow up endpoint
Measured: 6-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start1 Feb 2015
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348566
- Sponsor's protocol ID
- NHS25487541
- Status last verified
- Dec 2023
- First submitted
- 26 Oct 2017
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data belongs to HSPH
Publications
Heianza Y, Qi L. Gene-Diet Interaction and Precision Nutrition in Obesity. Int J Mol Sci. 2017 Apr 7;18(4):787. doi: 10.3390/ijms18040787.
PubMed 28387720Qi Q, Chu AY, Kang JH, Huang J, Rose LM, Jensen MK, Liang L, Curhan GC, Pasquale LR, Wiggs JL, De Vivo I, Chan AT, Choi HK, Tamimi RM, Ridker PM, Hunter DJ, Willett WC, Rimm EB, Chasman DI, Hu FB, Qi L. Fried food consumption, genetic risk, and body mass index: gene-diet interaction analysis in three US cohort studies. BMJ. 2014 Mar 19;348:g1610. doi: 10.1136/bmj.g1610.
PubMed 24646652
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Change
- ClinicalTrials.gov ID
- NCT03348566
- Acronym / sponsor ID
- NHS25487541
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,000 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 21 Nov 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 investigators tested whether genetic variants near FADS cluster, which were recently identified to be signatures of adaptation to fish- and n-3 PUFAs-rich diet, interacted with these dietary factors on long-term change of body mass index (BMI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Nurses' Health Study began in 1976, when 121,700 female registered nurses aged 30-55 y were recruited to complete a baseline questionnaire. the investigators included 11,323 women of European ancestry. Informed consent was obtained from all participants. The Health Professionals Follow-up Study The HPFS was initiated in 1986, and was composed of 51,529 male aged 40-75 y at baseline. This study included 6,833 men whose genotype data were available. Informed consent was obtained from all participants. The Women's Health Initiative (WHI) is a large, multiethnic, 40-center study that focuses on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. 6,254 Caucasians women with European ancestry were included. The design of Singapore Chinese Health Study (SCHS): Between 1993 and 1998, 63,257 Chinese between 45 and 74 in Singapore were enrolled. 5,264 subjects with genotyping data were included in this analysis.
Key inclusion criteria (4 listed)
- 11,323 women of European ancestry.
- Informed consent was obtained from all participants. The DNA extraction methods, quality control measures,
- SNPs genotyping and imputation data are available .
- Both cases and controls with genotyping data are available based on GWASs
Key exclusion criteria (1 listed)
- participants without genetic data
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 |
|---|---|---|
| fishfish intkae | Other | – |
Primary outcome
weight changes
Time frame: 6-10 years
long term weight changes: this study measured body weight at baseline (1990) and follow up body weight in 2000. The long term body weight was defined as changes from baseline to follow up endpoint
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 19 Dec 2023.
- Background: PubMed 28387720Heianza Y, Qi L. Gene-Diet Interaction and Precision Nutrition in Obesity. Int J Mol Sci. 2017 Apr 7;18(4):787. doi: 10.3390/ijms18040787.
- Background: PubMed 24646652Qi Q, Chu AY, Kang JH, Huang J, Rose LM, Jensen MK, Liang L, Curhan GC, Pasquale LR, Wiggs JL, De Vivo I, Chan AT, Choi HK, Tamimi RM, Ridker PM, Hunter DJ, Willett WC, Rimm EB, Chasman DI, Hu FB, Qi L. Fried food consumption, genetic risk, and body mass index: gene-diet interaction analysis in three US cohort studies. BMJ. 2014 Mar 19;348:g1610. doi: 10.1136/bmj.g1610.
- Individual participant dataSharing planned: No. The data belongs to HSPH
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Harvard School of Public Health (HSPH).
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 4 inclusion and 1 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 changes (time frame: 6-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03348566, which also lists 2 linked publications.
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 19 Dec 2023.