Obesity & OverweightPNODNCT07850531
Precision Nutrition for Obesity and Prediabetes Prevention in Under-supported Communities
A study testing Precision Nutrition Intervention and Standard Nutrition Counseling in people with Obesity & Overweight and Prediabetes, run by Prairie View A&M University at 1 site in United States.
Trial summary
This randomized controlled trial will evaluate the effectiveness of a culturally sensitive precision nutrition intervention for improving obesity- and diabetes-related outcomes among African American and Hispanic/Latino adults who are overweight, obese, or have prediabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight, Prediabetes
- What is being tested?
- Precision Nutrition Intervention and Standard Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years
- African American or Hispanic/Latino adults
- Residents of Texas
- Body mass index (BMI) ≥ 25 kg/m² and/or fasting blood glucose levels of 100-125 mg/dL
- Hemoglobin A1C (HbA1C) between 5.7% and 6.4%
- Daily access to a cell phone and the internet
- Able to participate in moderate-to-vigorous physical activity
- Able and willing to provide informed consent
Who cannot join
- Do not meet the inclusion criteria
- Following a prescribed diet for any reason, including weight loss, within the previous 3 months
- Diagnosed diabetes mellitus
- Cardiovascular disease
- Eating disorders
- Lung disease
Show all 11Show fewer
- Liver disease
- Thyroid disease
- Crohn's disease
- Pregnant
- Lactating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
integrated Nutrition Intervention for Community and Health Enhancement Laboratory (iNICHE Lab)
Prairie View, Texas, 77446
Janet Antwi, B.Pharm, M.S, Ph.D, RPh, RD,, 9362612536, jaantwi@pvamu.edu
Janet Antwi, B.Pharm, M.S, Ph.D, RPh, RD,
About this study
Official title: Building Capacity in Precision Nutrition to Address Obesity and Diabetes in Underserved Communities
This randomized controlled trial will evaluate the effectiveness of a culturally sensitive precision nutrition intervention for improving obesity- and diabetes-related outcomes among African American and Hispanic/Latino adults who are overweight, obese, or have prediabetes. Participants will be randomized to either a precision nutrition intervention group or a control group receiving standard nutrition counseling and educational materials. The intervention incorporates individualized dietary recommendations based on participant characteristics, including dietary habits, physical activity, socioeconomic factors, psychosocial factors, phenotype, and genotype. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks and will include body weight, diet quality, fasting blood glucose, hemoglobin A1C, body composition, physical activity, blood pressure, and metabolic biomarkers. Feasibility, acceptability, and sustainability of the intervention will also be evaluated.
Read the detailed description
Obesity and prediabetes are major public health concerns and disproportionately affect under-supported populations, including African American and Hispanic/Latino communities. Traditional nutrition interventions often use a one-size-fits-all approach and may not adequately account for individual variability in biological, behavioral, and environmental factors that influence health outcomes. Precision nutrition is an emerging approach that tailors nutrition recommendations to individual characteristics such as dietary intake, physical activity, health status, genotype, phenotype, psychosocial influences, and environmental exposures. Advances in nutrition science, artificial intelligence, and machine learning have created opportunities to integrate these factors and deliver more personalized dietary and lifestyle recommendations. The purpose of this study is to determine whether a culturally sensitive precision nutrition intervention can improve obesity and type 2 diabetes risk factors among African American and Hispanic/Latino adults living in Texas. The study will recruit adults aged 18 to 65 years with overweight, obesity, and/or prediabetes. Participants will be randomized to either an intervention group or a control group. The intervention group will receive tailored nutrition counseling, individualized meal planning, physical activity guidance, behavior-change education, and access to a mobile-health platform to support healthy lifestyle modification. The intervention will incorporate motivational interviewing techniques and social support resources. The control group will receive standard nutrition counseling and educational materials. Data collection will occur at baseline, 6 weeks, and 12 weeks. Measures will include sociodemographic information, dietary intake, food security, anthropometric and body composition assessments, physical activity, blood pressure, fasting blood glucose, hemoglobin A1C, lipid profile, genetic markers, gut microbiome measures, inflammatory markers, and cognitive assessments. Qualitative interviews and focus group discussions will be used to explore participant experiences and intervention acceptability. Primary outcomes include changes in body weight, diet quality, and fasting blood glucose. Secondary outcomes include changes in hemoglobin A1C, body composition, blood pressure, lipid profile, physical activity levels, feasibility, acceptability, compliance, and sustainability of intervention effects. Findings from this study will provide preliminary evidence regarding the effectiveness and feasibility of precision nutrition approaches for obesity and diabetes prevention in under-supported populations.
- Conditions
- Obesity & Overweight, Prediabetes
- Being tested
- Precision Nutrition Intervention, Standard Nutrition Counseling
- Keywords
- Precision Nutrition, Personalized Nutrition, Weight Loss, Diabetes Prevention, Nutrition Counseling, Physical Activity, Culturally Sensitive Intervention, African American Adults, Hispanic/Latino Adults, Prediabetes, Obesity
- Medical subject headings
- Obesity, Overweight, Prediabetic State, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Nutrition InterventionBehavioural
A personalized precision nutrition program tailored to participants' dietary habits, physical activity, socioeconomic characteristics, psychosocial factors, phenotype, and genotype. The intervention includes nutrition counseling, physical activity guidance, behavioral education, mobile-health support, and social support activities.
Standard Nutrition CounselingBehavioural
Also called Standard Nutrition Counseling Control
Standard nutrition counseling and educational materials are delivered in accordance with usual nutrition education practices.
| Study group | Role | What they receive |
|---|---|---|
| Precision Nutrition Intervention | Experimental | Participants will receive a culturally sensitive precision nutrition intervention including individualized nutrition counseling, personalized meal planning, physical activity guidance, health behavior lessons, mobile-health support, motivational interviewing, and social support resources. Receives: Behavioral: Precision Nutrition Intervention |
| Standard Nutrition Counseling Control | Active comparator | Participants will receive standard nutrition counseling and dietary education materials without individualized precision nutrition recommendations. Receives: Behavioral: Standard Nutrition Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change in measured body weight, expressed in kilograms (kg), from baseline following participation in the precision nutrition intervention or standard nutrition counseling control condition.
Measured: Baseline, 6 weeks, and 12 weeks
Change in Healthy Eating Index (HEI)-2020 Total Score
Change in Healthy Eating Index (HEI)-2020 total score derived from participants' dietary intake data collected using 24-hour dietary recalls. HEI-2020 scores range from 0 to 100, with higher scores indicating better diet quality and greater adherence to the Dietary Guidelines for Americans.
Measured: Baseline, 6 weeks, and 12 weeks
Change in Fasting Blood Glucose
Change in fasting blood glucose concentration, expressed in milligrams per deciliter (mg/dL), from baseline following participation in the precision nutrition intervention or standard nutrition counseling control condition.
Measured: Baseline, 6 weeks, and 12 weeks
Secondary outcomes (14)
Change in Hemoglobin A1C (HbA1C)
Change in haemoglobin A1C concentration, expressed as a percentage of total haemoglobin (%), as a measure of long-term glycemic control.
Measured: Baseline, 6 weeks, and 12 weeks
Change in Body Fat Percentage
Change in body fat percentage (%) measured using body composition assessment methods.
Measured: Baseline, 6 weeks, and 12 weeks
Change in Skeletal Muscle Mass
Change in skeletal muscle mass, expressed in kilograms (kg), measured using body composition assessment methods. Change in skeletal muscle mass, expressed in kilograms (kg), measured using body composition assessment methods.
Measured: Baseline, 6 weeks, and 12 weeks
Change in Waist Circumference
Change in waist circumference, expressed in centimeters (cm), measured using standardized anthropometric procedures.
Measured: Baseline, 6 weeks, and 12 weeks
Change in Body Mass Index (BMI)
Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²).
Measured: Baseline, 6 weeks, and 12 weeks
Change in Average Daily Step Count
Change in average daily step count measured using a pedometer.
Measured: Baseline, 6 weeks, and 12 weeks
Change in Energy Expenditure
Change in activity-related energy expenditure, expressed in kilocalories per day (kcal/day), measured using a pedometer or activity-monitoring device.
Measured: Baseline, 6 weeks, and 12 weeks
Change in Blood Pressure
Change in Change in systolic and diastolic blood pressure measurements, expressed in millimeters of mercury (mmHg), measured using standardized procedures.
Measured: Baseline, 6 weeks, and 12 weeks
Change in Lipid Profile
Change in total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride concentrations, expressed in milligrams per deciliter (mg/dL).
Measured: Baseline, 6 weeks, and 12 weeks
Program Compliance
Percentage of prescribed nutrition counseling activities, dietary recommendations, and physical activity recommendations completed by participants during the intervention period.
Measured: Throughout study completion (up to 12 weeks)
Participant Recruitment Rate
Percentage of eligible individuals who enroll in the study among all individuals screened for participation.
Measured: Throughout study completion (up to 12 weeks)
Participant Retention Rate
Percentage of enrolled participants who complete all study assessments through the end of the intervention period.
Measured: Throughout study completion (up to 12 weeks)
Participant Satisfaction Questionnaire Score
Participant satisfaction with the intervention measured using a study-specific satisfaction questionnaire. The level of satisfaction will be scored on a likert scale.
Measured: Throughout study completion (up to 12 weeks)
Program Favorability Questionnaire Score
Participant perceptions of the intervention measured using a study-specific program favorability questionnaire. Scores will be on a likert scale that reflects perceptions of the intervention.
Measured: Throughout study completion (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies 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
- Model description
- Participants will be randomized to either a precision nutrition intervention group or a control group receiving standard nutrition counseling and educational materials. Both groups will be followed concurrently throughout the study, and outcomes will be compared between groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prairie View A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Janet Antwi, Prairie View A&M University
- Investigators
- Janet Antwi, B.Pharm, M.S, Ph.D, RPh, RD,, Principal investigator, Prairie View A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850531
- Sponsor's protocol ID
- 2022-027
- Acronym
- PNOD
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications, including demographic, dietary, anthropometric, physical activity, metabolic, and survey data collected during the study.
Publications
de Toro-Martin J, Arsenault BJ, Despres JP, Vohl MC. Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. Nutrients. 2017 Aug 22;9(8):913. doi: 10.3390/nu9080913.
PubMed 28829397Jinnette R, Narita A, Manning B, McNaughton SA, Mathers JC, Livingstone KM. Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. Adv Nutr. 2021 Jun 1;12(3):657-669. doi: 10.1093/advances/nmaa144.
PubMed 33313795Livingstone KM, Ramos-Lopez O, Perusse L, Kato H, Ordovas JM, Martinez JA. Precision nutrition: A review of current approaches and future endeavors. Trends in Food Science and Technology. 2022.
Ordovas JM, Ferguson LR, Tai ES, Mathers JC. Personalised nutrition and health. BMJ. 2018 Jun 13;361:bmj.k2173. doi: 10.1136/bmj.k2173.
PubMed 29898881Celis-Morales C, Livingstone KM, Marsaux CF, Macready AL, Fallaize R, O'Donovan CB, Woolhead C, Forster H, Walsh MC, Navas-Carretero S, San-Cristobal R, Tsirigoti L, Lambrinou CP, Mavrogianni C, Moschonis G, Kolossa S, Hallmann J, Godlewska M, Surwillo A, Traczyk I, Drevon CA, Bouwman J, van Ommen B, Grimaldi K, Parnell LD, Matthews JN, Manios Y, Daniel H, Martinez JA, Lovegrove JA, Gibney ER, Brennan L, Saris WH, Gibney M, Mathers JC; Food4Me Study. Effect of personalized nutrition on health-related behaviour change: evidence from the Food4Me European randomized controlled trial. Int J Epidemiol. 2017 Apr 1;46(2):578-588. doi: 10.1093/ije/dyw186.
PubMed 27524815
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity in Precision Nutrition to Address Obesity and Diabetes in Underserved Communities
- ClinicalTrials.gov ID
- NCT07850531
- Acronym / sponsor ID
- PNOD / 2022-027
- Conditions
- Obesity & Overweight, Prediabetes
- Keywords
- Precision Nutrition, Personalized Nutrition, Weight Loss, Diabetes Prevention, Nutrition Counseling, Physical Activity, Culturally Sensitive Intervention, African American Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Prairie View A&M UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 30 Sep 2026 (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.
This randomized controlled trial will evaluate the effectiveness of a culturally sensitive precision nutrition intervention for improving obesity- and diabetes-related outcomes among African American and Hispanic/Latino adults who are overweight, obese, or have prediabetes. Participants will be randomized to either a precision nutrition intervention group or a control group receiving standard nutrition counseling and educational materials. The intervention incorporates individualized dietary recommendations based on participant characteristics, including dietary habits, physical activity, socioeconomic factors, psychosocial factors, phenotype, and genotype. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks and will include body weight, diet quality, fasting blood glucose, hemoglobin A1C, body composition, physical activity, blood pressure, and metabolic biomarkers. Feasibility, acceptability, and sustainability of the intervention will also be evaluated.
Detailed description
Obesity and prediabetes are major public health concerns and disproportionately affect under-supported populations, including African American and Hispanic/Latino communities. Traditional nutrition interventions often use a one-size-fits-all approach and may not adequately account for individual variability in biological, behavioral, and environmental factors that influence health outcomes. Precision nutrition is an emerging approach that tailors nutrition recommendations to individual characteristics such as dietary intake, physical activity, health status, genotype, phenotype, psychosocial influences, and environmental exposures. Advances in nutrition science, artificial intelligence, and machine learning have created opportunities to integrate these factors and deliver more personalized dietary and lifestyle recommendations. The purpose of this study is to determine whether a culturally sensitive precision nutrition intervention can improve obesity and type 2 diabetes risk factors among African American and Hispanic/Latino adults living in Texas. The study will recruit adults aged 18 to 65 years with overweight, obesity, and/or prediabetes. Participants will be randomized to either an intervention group or a control group. The intervention group will receive tailored nutrition counseling, individualized meal planning, physical activity guidance, behavior-change education, and access to a mobile-health platform to support healthy lifestyle modification. The intervention will incorporate motivational interviewing techniques and social support resources. The control group will receive standard nutrition counseling and educational materials. Data collection will occur at baseline, 6 weeks, and 12 weeks. Measures will include sociodemographic information, dietary intake, food security, anthropometric and body composition assessments, physical activity, blood pressure, fasting blood glucose, hemoglobin A1C, lipid profile, genetic markers, gut microbiome measures, inflammatory markers, and cognitive assessments. Qualitative interviews and focus group discussions will be used to explore participant experiences and intervention acceptability. Primary outcomes include changes in body weight, diet quality, and fasting blood glucose. Secondary outcomes include changes in hemoglobin A1C, body composition, blood pressure, lipid profile, physical activity levels, feasibility, acceptability, compliance, and sustainability of intervention effects. Findings from this study will provide preliminary evidence regarding the effectiveness and feasibility of precision nutrition approaches for obesity and diabetes prevention in under-supported populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either a precision nutrition intervention group or a control group receiving standard nutrition counseling and educational materials. Both groups will be followed concurrently throughout the study, and outcomes will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Precision Nutrition Intervention | Experimental | Behavioral: Precision Nutrition InterventionParticipants will receive a culturally sensitive precision nutrition intervention including individualized nutrition counseling, personalized meal planning, physical activity guidance, health behavior lessons, mobile-health support, motivational interviewing, and social support resources. |
| Standard Nutrition Counseling Control | Active comparator | Behavioral: Standard Nutrition CounselingParticipants will receive standard nutrition counseling and dietary education materials without individualized precision nutrition recommendations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 to 65 years
- African American or Hispanic/Latino adults
- Residents of Texas
- Body mass index (BMI) ≥ 25 kg/m² and/or fasting blood glucose levels of 100-125 mg/dL
- Hemoglobin A1C (HbA1C) between 5.7% and 6.4%
Key exclusion criteria (11 listed)
- Do not meet the inclusion criteria
- Following a prescribed diet for any reason, including weight loss, within the previous 3 months
- Diagnosed diabetes mellitus
- Cardiovascular disease
- Eating disorders
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 |
|---|---|---|
| Precision Nutrition InterventionA personalized precision nutrition program tailored to participants' dietary habits, physical activity, socioeconomic characteristics, psychosocial factors, phenotype, and genotype. The intervention includes nutrition counseling, physical activity guidance, behavioral education, mobile-health support, and social support activities. | Behavioural | Precision Nutrition Intervention |
| Standard Nutrition CounselingAlso: Standard Nutrition Counseling ControlStandard nutrition counseling and educational materials are delivered in accordance with usual nutrition education practices. | Behavioural | Standard Nutrition Counseling Control |
Primary outcome
Change in Body Weight
Time frame: Baseline, 6 weeks, and 12 weeks
Change in measured body weight, expressed in kilograms (kg), from baseline following participation in the precision nutrition intervention or standard nutrition counseling control condition.
Change in Healthy Eating Index (HEI)-2020 Total Score
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Healthy Eating Index (HEI)-2020 total score derived from participants' dietary intake data collected using 24-hour dietary recalls. HEI-2020 scores range from 0 to 100, with higher scores indicating better diet quality and greater adherence to the Dietary Guidelines for Americans.
Change in Fasting Blood Glucose
Time frame: Baseline, 6 weeks, and 12 weeks
Change in fasting blood glucose concentration, expressed in milligrams per deciliter (mg/dL), from baseline following participation in the precision nutrition intervention or standard nutrition counseling control condition.
14 secondary outcomes
Change in Hemoglobin A1C (HbA1C)
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Body Fat Percentage
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Skeletal Muscle Mass
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Waist Circumference
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Body Mass Index (BMI)
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Average Daily Step Count
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Energy Expenditure
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Blood Pressure
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Lipid Profile
Time frame: Baseline, 6 weeks, and 12 weeks
Program Compliance
Time frame: Throughout study completion (up to 12 weeks)
Participant Recruitment Rate
Time frame: Throughout study completion (up to 12 weeks)
Participant Retention Rate
Time frame: Throughout study completion (up to 12 weeks)
Participant Satisfaction Questionnaire Score
Time frame: Throughout study completion (up to 12 weeks)
Program Favorability Questionnaire Score
Time frame: Throughout study completion (up to 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 28829397de Toro-Martin J, Arsenault BJ, Despres JP, Vohl MC. Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. Nutrients. 2017 Aug 22;9(8):913. doi: 10.3390/nu9080913.
- Background: PubMed 33313795Jinnette R, Narita A, Manning B, McNaughton SA, Mathers JC, Livingstone KM. Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. Adv Nutr. 2021 Jun 1;12(3):657-669. doi: 10.1093/advances/nmaa144.
- BackgroundLivingstone KM, Ramos-Lopez O, Perusse L, Kato H, Ordovas JM, Martinez JA. Precision nutrition: A review of current approaches and future endeavors. Trends in Food Science and Technology. 2022.
- Background: PubMed 29898881Ordovas JM, Ferguson LR, Tai ES, Mathers JC. Personalised nutrition and health. BMJ. 2018 Jun 13;361:bmj.k2173. doi: 10.1136/bmj.k2173.
- Background: PubMed 27524815Celis-Morales C, Livingstone KM, Marsaux CF, Macready AL, Fallaize R, O'Donovan CB, Woolhead C, Forster H, Walsh MC, Navas-Carretero S, San-Cristobal R, Tsirigoti L, Lambrinou CP, Mavrogianni C, Moschonis G, Kolossa S, Hallmann J, Godlewska M, Surwillo A, Traczyk I, Drevon CA, Bouwman J, van Ommen B, Grimaldi K, Parnell LD, Matthews JN, Manios Y, Daniel H, Martinez JA, Lovegrove JA, Gibney ER, Brennan L, Saris WH, Gibney M, Mathers JC; Food4Me Study. Effect of personalized nutrition on health-related behaviour change: evidence from the Food4Me European randomized controlled trial. Int J Epidemiol. 2017 Apr 1;46(2):578-588. doi: 10.1093/ije/dyw186.
- Prairie View A\&M UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications, including demographic, dietary, anthropometric, physical activity, metabolic, and survey data collected during the study.
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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.
Janet Antwi, B.Pharm, M.S, Ph.D, RPh, RD, principal investigator
Prairie View A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Nutrition Intervention and Standard Nutrition Counseling in people with Obesity & Overweight and Prediabetes, run by Prairie View A&M University at 1 site in United States.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 30 Sep 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Antwi, B.Pharm, M.S, Ph.D, RPh, RD, (9362612536, jaantwi@pvamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline, 6 weeks, and 12 weeks). The study lists 3 primary outcomes in all. 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 NCT07850531, which also lists 5 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 30 Sep 2026.