Gene and Diet InteractionNCT03577639
Diet Quality and Genetic Association With Body Mass Index: Results From Three Observational Studies
An observational study of Gene and Diet Interaction, run by Harvard School of Public Health (HSPH).
Trial summary
Background In the most recent genome-wide association study (GWAS), of the 97 body mass index (BMI)-associated single nucleotide polymorphisms (SNPs) identified, more than half of the SNPs were highly enriched for expression in the central nervous system (CNS), which is the key site of central appetite regulation 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gene and Diet Interaction
- How many people
- 11,700 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1976to 12 Dec 1990
- 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: * 5,730 women in the NHS and 3,434 men in the HPFS who were sampled as controls * 21,740 women in the WHGS
Who may be able to join
- Participants with genetic data
Who cannot join
- Participants with a history of diabetes, cardiovascular disease, and cancer
About this study
Background In the most recent genome-wide association study (GWAS), of the 97 body mass index (BMI)-associated single nucleotide polymorphisms (SNPs) identified, more than half of the SNPs were highly enriched for expression in the central nervous system (CNS), which is the key site of central appetite regulation 1. Significant interaction between consumption of sugar-sweetened beverages and genetic score in relation to BMI has been found 2. However, it is not known whether diet quality could modify the genetic association with BMI. Moreover, identification of subgroup of established SNPs whose association with BMI could be most significantly modified by diet will provide evidence to individualized obesity prevention.
Hypotheses
Read more
- SNPs enriched in the CNS (CNS SNPs) were more likely to be associated with food and nutrient intakes featured in alternative healthy eating index (AHEI) in comparison to SNPs enriched in other tissues (non-CNS SNPs).
- Higher diet quality was related with less pronounced association between genetic score and BMI, particularly the score of CNS SNPs.
Study Population
- 5,730 women in the Nurses Health Study (NHS) and 3,434 men in the Health Professional Follow-up Study (HPFS) who were sampled as controls
- 21,740 women in the Women's Genome Health Study (WGHS) Exposure
- Dietary quality will be measured by AHEI-2010, alternate Mediterranean diet (AMED), and the Dietary Approaches to Stop Hypertension (DASH) diet scores. Diet was measured repeatedly in the NHS (1984, 1986, 1990, 1994) and the HPFS (1986, 1990, 1994), and was measured at baseline in the WGHS.
- Based on the most recent GWAS 1, we will classify the 97 BMI-associated SNPs into CNS SNP (54 SNPs) and non-CNS SNP (43 SNPs). Total, CNS, and non-CNS SNP scores will be calculated.
Outcome BMI measured after diet assessment with 2-year lag in the NHS and the HPFS and 3-year lag in the WGHS Statistical analysis
- The associations of individual SNP with AHEI components at baseline will be examined using linear regression and the results will be presented in Heatmap.
- The interactions between diet quality scores and genetic scores in relation to BMI will be examined using generalized linear model in the NHS and the HPFS and using linear regression in the WGHS. The genetic scores will include total SNP score, CNS SNP score, and non-CNS SNP score.
- Two-way stratification analysis will be conducted: the association of diet quality score with BMI will be stratified by genetic score; the association of genetic score with BMI will be stratified by diet quality score.
- The interactions between AHEI components and genetic scores in relation to BMI will be examined using generalized linear model in the NHS and the HPFS and using linear regression in the WGHS.
- Conditions
- Gene and Diet Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: 1984-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Jan 1976
- Primary completion12 Dec 1986
- Study completion12 Dec 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gene and Diet InteractionStudies 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
- 11,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Ding, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577639
- Sponsor's protocol ID
- 384957
- Status last verified
- Apr 2021
- First submitted
- 13 Jun 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ding M, Ellervik C, Huang T, Jensen MK, Curhan GC, Pasquale LR, Kang JH, Wiggs JL, Hunter DJ, Willett WC, Rimm EB, Kraft P, Chasman DI, Qi L, Hu FB, Qi Q. Diet quality and genetic association with body mass index: results from 3 observational studies. Am J Clin Nutr. 2018 Dec 1;108(6):1291-1300. doi: 10.1093/ajcn/nqy203.
PubMed 30351367
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Quality and Genetic Association With Body Mass Index: Results From Three Observational Studies
- ClinicalTrials.gov ID
- NCT03577639
- Acronym / sponsor ID
- 384957
- Conditions
- Gene and Diet Interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,700 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- 1 Jan 1976 (actual)
- Primary completion
- 12 Dec 1986 (actual)
- Study completion
- 12 Dec 1990 (actual)
- First posted
- 5 Jul 2018 (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.
Background In the most recent genome-wide association study (GWAS), of the 97 body mass index (BMI)-associated single nucleotide polymorphisms (SNPs) identified, more than half of the SNPs were highly enriched for expression in the central nervous system (CNS), which is the key site of central appetite regulation 1. Significant interaction between consumption of sugar-sweetened beverages and genetic score in relation to BMI has been found 2. However, it is not known whether diet quality could modify the genetic association with BMI. Moreover, identification of subgroup of established SNPs whose association with BMI could be most significantly modified by diet will provide evidence to individualized obesity prevention.
Hypotheses
- SNPs enriched in the CNS (CNS SNPs) were more likely to be associated with food and nutrient intakes featured in alternative healthy eating index (AHEI) in comparison to SNPs enriched in other tissues (non-CNS SNPs).
- Higher diet quality was related with less pronounced association between genetic score and BMI, particularly the score of CNS SNPs.
Study Population
- 5,730 women in the Nurses Health Study (NHS) and 3,434 men in the Health Professional Follow-up Study (HPFS) who were sampled as controls
- 21,740 women in the Women's Genome Health Study (WGHS) Exposure
- Dietary quality will be measured by AHEI-2010, alternate Mediterranean diet (AMED), and the Dietary Approaches to Stop Hypertension (DASH) diet scores. Diet was measured repeatedly in the NHS (1984, 1986, 1990, 1994) and the HPFS (1986, 1990, 1994), and was measured at baseline in the WGHS.
- Based on the most recent GWAS 1, we will classify the 97 BMI-associated SNPs into CNS SNP (54 SNPs) and non-CNS SNP (43 SNPs). Total, CNS, and non-CNS SNP scores will be calculated.
Outcome BMI measured after diet assessment with 2-year lag in the NHS and the HPFS and 3-year lag in the WGHS Statistical analysis
- The associations of individual SNP with AHEI components at baseline will be examined using linear regression and the results will be presented in Heatmap.
- The interactions between diet quality scores and genetic scores in relation to BMI will be examined using generalized linear model in the NHS and the HPFS and using linear regression in the WGHS. The genetic scores will include total SNP score, CNS SNP score, and non-CNS SNP score.
- Two-way stratification analysis will be conducted: the association of diet quality score with BMI will be stratified by genetic score; the association of genetic score with BMI will be stratified by diet quality score.
- The interactions between AHEI components and genetic scores in relation to BMI will be examined using generalized linear model in the NHS and the HPFS and using linear regression in the WGHS.
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
- * 5,730 women in the NHS and 3,434 men in the HPFS who were sampled as controls * 21,740 women in the WHGS
Key inclusion criteria (1 listed)
- Participants with genetic data
Key exclusion criteria (1 listed)
- Participants with a history of diabetes, cardiovascular disease, and cancer
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 |
|---|---|---|
| Other | – |
Primary outcome
Body mass index
Time frame: 1984-2010
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 29 Apr 2021.
- Derived from this study: PubMed 30351367Ding M, Ellervik C, Huang T, Jensen MK, Curhan GC, Pasquale LR, Kang JH, Wiggs JL, Hunter DJ, Willett WC, Rimm EB, Kraft P, Chasman DI, Qi L, Hu FB, Qi Q. Diet quality and genetic association with body mass index: results from 3 observational studies. Am J Clin Nutr. 2018 Dec 1;108(6):1291-1300. doi: 10.1093/ajcn/nqy203.
- Individual participant dataSharing planned: Undecided
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 Gene and Diet Interaction, 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 1 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 29 Apr 2021. 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?
Body mass index (time frame: 1984-2010). 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 NCT03577639, which also lists 1 linked publication.
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 29 Apr 2021.