Dietary ChangeNCT07244458
Dietary Peanuts and Nutrition-Related Outcomes
A study testing Peanuts and Dual-energy X-ray absorptiometry (DEXA) scans in people with Dietary Change and Obesity & Overweight, run by Ian J. Neeland, MD at 1 site in United States.
Trial summary
This study will look at how eating peanuts every day might affect participants weight, how healthy their diet is, and how they feel when eating. Investigators want to see if adding peanuts to meals for 12 weeks helps participants feel fuller, have more energy, and improve body composition. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Change, Obesity & Overweight, Food Acceptance
- What is being tested?
- Peanuts and Dual-energy X-ray absorptiometry (DEXA) scans
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with a BMI ≥30 kg/m2 or with a BMI ≥27 kg/m2 with at least one weight-related comorbidity who have been using semaglutide or tirzepatide for a clinical indication or at least 6 months
Who cannot join
- No use or contraindication to use of a GLP-1 RA
- Known allergy to nuts
- Pregnant or breastfeeding
- Incarcerated
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, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Clevland, Ohio, 44106
Ian Neeland, MD, 216-844-5965, Ian.Neeland@UHhospitals.org
Abigail Raffner, PhD, RD, LD, 216-368-0756, Abigail.Raffner@UHhospitals.org
About this study
Official title: Dietary Peanut Intake and Nutrition-Related Outcomes in Individuals Using GLP-1 Receptor Agonists: A Randomized Controlled Trial
This study will look at how eating peanuts every day might affect participants weight, how healthy their diet is, and how they feel when eating. Investigators want to see if adding peanuts to meals for 12 weeks helps participants feel fuller, have more energy, and improve body composition. The study will include adults who have been taking GLP-1 medicines like semaglutide or tirzepatide for at least three months. Investigators also want to see if eating peanuts improves overall diet quality and health markers like tiredness and certain levels in blood.
- Conditions
- Dietary Change, Obesity & Overweight, Food Acceptance
- Being tested
- Peanuts, Dual-energy X-ray absorptiometry (DEXA) scans
- Keywords
- Dietary quality, Eating enjoyment, Satiety, Weight-related outcomes
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeanutsDietary supplement
Participants will eat 2 ounces, or about 53 grams, of dry-roasted, lightly salted peanuts each day along with their regular diet
Dual-energy X-ray absorptiometry (DEXA) scansProcedure or surgery
DEXA scans will be used to measure body fat
| Study group | Role | What they receive |
|---|---|---|
| Peanut Group | Experimental | Participants in this group will eat 2 ounces, or 53 grams of dry-roasted, lightly salted (low sodium) each day along with their regular diet. Receives: Dietary Supplement: Peanuts; Procedure: Dual-energy X-ray absorptiometry (DEXA) scans |
| No Peanut Group | Active comparator | Participants in this group will continue eating regular diet without peanuts. Receives: Procedure: Dual-energy X-ray absorptiometry (DEXA) scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS)
Participants will rate their perceived hunger, fullness, and desire to eat on a 100-mm scale, with endpoints ranging from "not at all" to "extremely" for each category.
Measured: Baseline, End of study (12 weeks)
Change in fatigue as measured by the Fatigue Severity VAS-F Survey
Each item is presented on a 100-mm scale, with endpoints labeled to reflect the extremes of the sensation being measured (e.g., "Not at all tired" to "Extremely tired"). Participants will complete the VAS-F at consistent times of the day to minimize variability. Scores will be recorded both before and after meals to capture potential fluctuations in energy levels.
Measured: Baseline, End of study (12 weeks)
Change in mood/well-being as measured by the Mental clarity, energy levels, and motivation VAS.
Each item is presented on a 100-mm scale, with endpoints labeled to reflect the extremes of being measured ranging from, for example, "not at all" to "extremely".
Measured: Baseline, End of study (12 weeks)
Change in dietary quality as measured by Healthy Eating Index (HEI)
HEI scores measure how well a diet aligns with the Dietary Guidelines for Americans. The scores range from 0 to 100, with higher scores indicating foods align with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
Measured: Baseline, End of study (12 weeks)
Change in food enjoyment as measured by the Food Pleasure Scale (FPS)
The FPS is a validated 21-item tool designed to measure multiple dimensions of food-related enjoyment, including sensory characteristics (appearance, odor, taste, texture), expectations and desires (memories, habits, expectations, choices, needs), and other relevant factors. The importance of each item in relation to general pleasurable experiences of food is rated on a 5-point ordinal scale ranging from 1 ("Not important at all") to 5 ("Extremely important").
Measured: Baseline, End of study (12 weeks)
Change in fasting glucose as measured by medical record review
Measured: Baseline, End of study (12 weeks)
Change in HbA1c as measured by medical record review
Measured: Baseline, End of study (12 weeks)
Change in total cholesterol as measured by medical record review
Measured: Baseline, End of study (12 weeks)
Change in LDL-C as measured by medical record review
Measured: Baseline, End of study (12 weeks)
Change in HDL-C as measured by medical record review
Measured: Baseline, End of study (12 weeks)
Change in triglycerides as measured by medical record review
Measured: Baseline, End of study (12 weeks)
Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ)
The IPAQ short form consists of 7 questions designed to assess physical activity levels over the past 7 days in adults. The score is calculated using published guidelines and ranges from 0 to infinity and measures physical activity in median median MET-minutes/week. This is a continuous measure and is calculated as: Total MET-min/week = (Walk METs*min*days) + (Moderate activity METs*min*days) + Vigorous activity METs*min*days).
Measured: Baseline, End of study (12 weeks)
Secondary outcomes (6)
Change in body weight as measured by medical record review
Measured: Baseline, End of study (12 weeks)
Change in waist circumference as measured by medical record review
Measured: Baseline, End of study (12 weeks)
Change in hip circumference as measured by medical record review
Measured: Baseline, End of study (12 weeks)
Change in fat mass as measured by DEXA scan
Measured: Baseline, End of study (12 weeks)
Change in lean body mass as measured by DEXA scan
Measured: Baseline, End of study (12 weeks)
Change in overall body fat percentage as measured by DEXA scan
Measured: Baseline, End of study (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ChangeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ian J. Neeland, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ian J. Neeland, MD, University Hospitals Cleveland Medical Center
- Investigators
- Ian Neeland, MD, Principal investigator, University Hospitals Cleveland Medical CenterAbigail Raffner, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244458
- Sponsor's protocol ID
- STUDY20250426
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Peanut Intake and Nutrition-Related Outcomes in Individuals Using GLP-1 Receptor Agonists: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07244458
- Acronym / sponsor ID
- STUDY20250426
- Conditions
- Dietary Change, Obesity & Overweight, Food Acceptance
- Keywords
- Dietary quality, Eating enjoyment, Satiety, Weight-related outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ian J. Neeland, MDUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Nov 2025 (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 study will look at how eating peanuts every day might affect participants weight, how healthy their diet is, and how they feel when eating. Investigators want to see if adding peanuts to meals for 12 weeks helps participants feel fuller, have more energy, and improve body composition. The study will include adults who have been taking GLP-1 medicines like semaglutide or tirzepatide for at least three months. Investigators also want to see if eating peanuts improves overall diet quality and health markers like tiredness and certain levels in blood.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut Group | Experimental | Dietary Supplement: Peanuts, Procedure: Dual-energy X-ray absorptiometry (DEXA) scansParticipants in this group will eat 2 ounces, or 53 grams of dry-roasted, lightly salted (low sodium) each day along with their regular diet. |
| No Peanut Group | Active comparator | Procedure: Dual-energy X-ray absorptiometry (DEXA) scansParticipants in this group will continue eating regular diet without peanuts. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with a BMI ≥30 kg/m2 or with a BMI ≥27 kg/m2 with at least one weight-related comorbidity who have been using semaglutide or tirzepatide for a clinical indication or at least 6 months
Key exclusion criteria (4 listed)
- No use or contraindication to use of a GLP-1 RA
- Known allergy to nuts
- Pregnant or breastfeeding
- Incarcerated
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 |
|---|---|---|
| PeanutsParticipants will eat 2 ounces, or about 53 grams, of dry-roasted, lightly salted peanuts each day along with their regular diet | Dietary supplement | Peanut Group |
| Dual-energy X-ray absorptiometry (DEXA) scansDEXA scans will be used to measure body fat | Procedure or surgery | No Peanut Group, Peanut Group |
Primary outcome
Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS)
Time frame: Baseline, End of study (12 weeks)
Participants will rate their perceived hunger, fullness, and desire to eat on a 100-mm scale, with endpoints ranging from "not at all" to "extremely" for each category.
Change in fatigue as measured by the Fatigue Severity VAS-F Survey
Time frame: Baseline, End of study (12 weeks)
Each item is presented on a 100-mm scale, with endpoints labeled to reflect the extremes of the sensation being measured (e.g., "Not at all tired" to "Extremely tired"). Participants will complete the VAS-F at consistent times of the day to minimize variability. Scores will be recorded both before and after meals to capture potential fluctuations in energy levels.
Change in mood/well-being as measured by the Mental clarity, energy levels, and motivation VAS.
Time frame: Baseline, End of study (12 weeks)
Each item is presented on a 100-mm scale, with endpoints labeled to reflect the extremes of being measured ranging from, for example, "not at all" to "extremely".
Change in dietary quality as measured by Healthy Eating Index (HEI)
Time frame: Baseline, End of study (12 weeks)
HEI scores measure how well a diet aligns with the Dietary Guidelines for Americans. The scores range from 0 to 100, with higher scores indicating foods align with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
Change in food enjoyment as measured by the Food Pleasure Scale (FPS)
Time frame: Baseline, End of study (12 weeks)
The FPS is a validated 21-item tool designed to measure multiple dimensions of food-related enjoyment, including sensory characteristics (appearance, odor, taste, texture), expectations and desires (memories, habits, expectations, choices, needs), and other relevant factors. The importance of each item in relation to general pleasurable experiences of food is rated on a 5-point ordinal scale ranging from 1 ("Not important at all") to 5 ("Extremely important").
Change in fasting glucose as measured by medical record review
Time frame: Baseline, End of study (12 weeks)
Change in HbA1c as measured by medical record review
Time frame: Baseline, End of study (12 weeks)
Change in total cholesterol as measured by medical record review
Time frame: Baseline, End of study (12 weeks)
Change in LDL-C as measured by medical record review
Time frame: Baseline, End of study (12 weeks)
Change in HDL-C as measured by medical record review
Time frame: Baseline, End of study (12 weeks)
Change in triglycerides as measured by medical record review
Time frame: Baseline, End of study (12 weeks)
Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, End of study (12 weeks)
The IPAQ short form consists of 7 questions designed to assess physical activity levels over the past 7 days in adults. The score is calculated using published guidelines and ranges from 0 to infinity and measures physical activity in median median MET-minutes/week. This is a continuous measure and is calculated as: Total MET-min/week = (Walk METs*min*days) + (Moderate activity METs*min*days) + Vigorous activity METs*min*days).
6 secondary outcomes
Change in body weight as measured by medical record review
Time frame: Baseline, End of study (12 weeks)
Change in waist circumference as measured by medical record review
Time frame: Baseline, End of study (12 weeks)
Change in hip circumference as measured by medical record review
Time frame: Baseline, End of study (12 weeks)
Change in fat mass as measured by DEXA scan
Time frame: Baseline, End of study (12 weeks)
Change in lean body mass as measured by DEXA scan
Time frame: Baseline, End of study (12 weeks)
Change in overall body fat percentage as measured by DEXA scan
Time frame: Baseline, End of study (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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Ian Neeland, MD principal investigator
University Hospitals Cleveland Medical Center
Abigail Raffner, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanuts and Dual-energy X-ray absorptiometry (DEXA) scans in people with Dietary Change and Obesity & Overweight, run by Ian J. Neeland, MD 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Apr 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 Ian Neeland, MD (216-844-5965, Ian.Neeland@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS) (time frame: Baseline, End of study (12 weeks)). The study lists 12 primary outcomes in all. 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 23 Apr 2026.