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Overweight , ObesityNCT07789769

A Trial to Examine the Effects of a Weight Loss Program Emphasizing Protein, Dietary Fiber, and Exercise (30-30-30 Plan)

A study testing 30-30-30 PFE Intervention and Standard in people with Overweight , Obesity, run by Midwest Center for Metabolic and Cardiovascular Research at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to learn whether following an online weight loss program with specific dietary and exercise goals (the 30-30-30 plan) can help improve weight loss and other markers of health when compared to an online weight loss program on its own. Read more about this study

Who is it for?
Ages 18 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Overweight , Obesity
What is being tested?
30-30-30 PFE Intervention and Standard
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
3 sitesUnited States
Study dates
23 Sep 2026to May 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 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Individual is a male or female and 18 to 69 years of age, inclusive.
  • Individual has a self-reported desire to lose weight.
  • Individual has a body mass index (BMI) ≥27.0 and ≤45.0 kg/m2.
  • Individual has calculated energy needs of ≥1800 kcal/d per the Mifflin-St Jeor Equation, with an adjustment for energy expended in physical activity.
  • Individual must be fluent in speaking, reading, and writing in English.
  • Individual owns a Bluetooth-compatible smartphone capable of downloading a fitness tracking app, with a camera, and has reliable Wi-Fi connectivity at home.
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  • Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening assessments.
  • Individual is willing and able to undergo the scheduled study procedures, including participating in an interactive, online weight loss program for 6 months, attending virtual meetings, and striving to fulfill dietary and exercise goals.
  • Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Who cannot join

  • Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
  • Individual is unwilling or unable to make dietary changes or increase physical activity.
  • Individual is unable to walk ¼ mile unaided without stopping.
  • Individual has a health condition (e.g., chronic pain, orthopedic limitations, heart problems) that would make weight loss or unsupervised exercise unsafe or infeasible. If an individual responds "yes" to any of the questions on the Physical Activity Readiness Questionnaire (PAR-Q) during visit 1, it is up to the Investigator's discretion to determine if unsupervised exercise is safe.
  • Individual habitually consumes >9 g fiber per 1000 kcal per day based on their responses on the fiber intake questionnaire.
  • Individual habitually engages in ≥210 minutes per week of moderate-intensity or higher physical activity based on their responses on the Stanford 7-Day Physical Activity Recall (Appendix 3).
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  • Individual regularly consumes (≥3 times per week) protein supplements, including collagen, within 30 days of visit 1.
  • Individual has a fasting blood glucose ≥126 mg/dL at screening or known type 1 or type 2 diabetes mellitus or use of any hypoglycemic medication (e.g., insulin, sodium glucose cotransporter-2 inhibitors, alpha glucosidase inhibitors, biguanides, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, meglitinides, sulfonylureas, glucagon-like peptide-1 (GLP-1) receptor agonists, and GLP-1/glucose-dependent insulinotropic polypeptide inhibitors), except for metformin, within 30 days of visit 1.
  • Individual has self-reported or clinically diagnosed bipolar disorder, psychosis, or severe depression.
  • Individual has been hospitalized for a psychiatric disorder during the past 12 months.
  • Individual has lost ≥5% of their body weight in the previous 6 months.
  • Individual has participated in a structured weight loss program (e.g., commercial program) within 30 days prior to visit 1.
  • Individual has a cardiac defibrillator or pacemaker.
  • Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important gastrointestinal (e.g., inflammatory bowel disease, Crohn's disease, colitis, irritable bowel syndrome, celiac disease), cardiac (e.g., angina, bypass surgery, or myocardial infarction within previous 6 months), renal, hepatic, endocrine (e.g., Cushing's disease), pulmonary, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
  • Daily use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
  • Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-day washout prior to visit 2 (week 0) and the participant must be willing to refrain from use during the study.
  • Individual has uncontrolled hypertension (systolic blood pressure ≥160 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥100 mm Hg) at screening.
  • Individual has untreated thyroid disease or unstable use (initiation or change in dose) of thyroid hormone replacement medications within 6 months of visit 1.
  • Use of any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications, etc.) within 30 days of visit 1. A stable dose of selective serotonin reuptake inhibitors ≥6 months is allowed.
  • Unstable use of any supplement known to affect energy metabolism within 30 days of visit 2.
  • Individual has a history of cancer in the prior 5 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
  • Individual has extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian).
  • Individual has a history of metabolic/bariatric surgery or plans to have any type of surgery during the study.
  • Individual has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) either diagnosed by a health professional or self-reported.
  • Individual has a history of any major trauma or major surgical event within 2 months of visit 1.
  • Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 5 days prior to any visit (washout is permitted for re-scheduling of the clinic visit).
  • Individual has an allergy, sensitivity, or intolerance to any components of the study foods.
  • Individual is a female who is pregnant, planning to become pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  • Individual has been exposed to any non-registered drug product within 30 days prior to visit 1.
  • Individual is a participant in another research study.
  • Individual has a current or recent history (within 12 months prior to screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 ounces (oz.) beer, 5 oz. wine, or 1.5 oz. hard liquor).
  • Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or puts the person at undue risk.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Caryn G Adams, MPH contact

6304696600

cwolfe@mbclinicalresearch.com

United States3 sites, 3 recruiting

  • Biofortis Clinical Research

    Addison, Illinois, 60101

    Gina Castiglione-Berg, 6306172000, gina.castiglione-berg@msxn.com

    Aditi Shah, MD

    Recruiting

  • Indiana University

    Bloomington, Indiana, 47405

    Karen Sprague, 812-855-7643, kaspragu@iu.edu

    Nana Gletsu-Miller, PhD

    Recruiting

  • Illinois Institute of Technology

    Chicago, Illinois, 60616

    Chelsea Preiss, MS, 3125675308, cpreiss@illlinoistech.edu

    Indika Edirisinghe, PhD

    Recruiting

Other trials in United States

About this study

Official title: A Randomized, Controlled Trial to Examine the Effects of an Online Weight Loss Program Emphasizing Protein, Dietary Fiber, and Exercise (30-30-30 Plan) on Body Weight, Body Composition, and Other Cardiometabolic Risk Factors

The purpose of this study is to learn whether following an online weight loss program with specific dietary and exercise goals (the 30-30-30 plan) can help improve weight loss and other markers of health when compared to an online weight loss program on its own.

Being tested
30-30-30 PFE Intervention, Standard
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 30-30-30 PFE InterventionBehavioural

    Interactive, online weight loss program adapted from the Rx Weight Loss (Rx WL) program with additional goals to consume ≥30 g protein/meal (P) + ≥30 g fiber/day (F) + ≥30 minutes of daily exercise (E).

  • StandardBehavioural

    Standard interactive, online weight loss program adapted from the Rx WL program.

Study groups in NCT07789769
Study groupRoleWhat they receive
StandardActive comparatorStandard interactive, online weight loss program adapted from the Rx Weight Loss (WL) program.
Receives: Behavioral: Standard
30-30-30 PFE interventionExperimentalInteractive, online weight loss program adapted from the Rx Weight Loss (Rx WL) program with additional goals to consume ≥30 g protein/meal (P) + ≥30 g fiber/day (F) + ≥30 minutes of daily exercise (E) (30-30-30 PFE intervention).
Receives: Behavioral: 30-30-30 PFE Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Weight

    Percentage change in body weight

    Measured: From week 0 to week 24

Secondary outcomes (18)

  1. Body Weight

    Percentage change in body weight

    Measured: From week 0 to week 8

  2. Body Weight

    Percentage change in body weight

    Measured: From week 0 to week 16

  3. Waist Circumference

    Percentage change in waist circumference

    Measured: From week 0 to week 8

  4. Waist Circumference

    Percentage change in waist circumference

    Measured: From week 0 to week 16

  5. Waist Circumference

    Percentage change in waist circumference

    Measured: From week 0 to week 24

  6. Body composition

    Percentage change in body composition (fat mass, fat-free mass, percent body fat)

    Measured: From week 0 to week 24

  7. Fasting levels of lipoprotein lipids

    Percentage change in fasting levels of lipoprotein lipids (total cholesterol, low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], non-HDL-C, triglycerides)

    Measured: From week 0 to week 8

  8. Fasting levels of lipoprotein lipids

    Percentage change in fasting levels of lipoprotein lipids (total cholesterol, LDL-C, HDL-C, non-HDL-C, triglycerides)

    Measured: From week 0 to week 16

  9. Fasting levels of lipoprotein lipids

    Percentage change in fasting levels of lipoprotein lipids (total cholesterol, LDL-C, HDL-C, non-HDL-C, triglycerides)

    Measured: From week 0 to week 24

  10. Fasting markers of glycemia

    Percentage change in fasting markers of glycemia (blood glucose, insulin, homeostasis model assessment of insulin resistance [HOMA-IR], homeostasis model assessment of beta-cell function [HOMA-B])

    Measured: From week 0 to week 8

  11. Fasting markers of glycemia

    Percentage change in fasting markers of glycemia (blood glucose, insulin, HOMA-IR, HOMA-B)

    Measured: From week 0 to week 16

  12. Fasting markers of glycemia

    Percentage change in fasting markers of glycemia (blood glucose, insulin, HOMA-IR, HOMA-B)

    Measured: From week 0 to week 24

  13. Composite measure of biomarkers of inflammation

    Percentage change in composite measure of biomarkers of inflammation (high-sensitivity C-reactive protein [hs-CRP], interleukin [IL]-6, IL-10, fibrinogen, and tumor necrosis factor-alpha [TNF-alpha])

    Measured: From week 0 to week 8

  14. Composite measure of biomarkers of inflammation

    Percentage change in composite measure of biomarkers of inflammation (hs-CRP, IL-6, IL-10, fibrinogen, and TNF-alpha)

    Measured: From week 0 to week 16

  15. Composite measure of biomarkers of inflammation

    Percentage change in composite measure of biomarkers of inflammation (hs-CRP, IL-6, IL-10, fibrinogen, and TNF-alpha)

    Measured: From week 0 to week 24

  16. Seated, resting systolic and diastolic blood pressures

    Percentage change in seated, resting systolic and diastolic blood pressures.

    Measured: From week 0 to week 8

  17. Seated, resting systolic and diastolic blood pressures

    Percentage change in seated, resting systolic and diastolic blood pressures.

    Measured: From week 0 to week 16

  18. Seated, resting systolic and diastolic blood pressures

    Percentage change in seated, resting systolic and diastolic blood pressures.

    Measured: From week 0 to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start23 Sep 2026
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07789769
Sponsor's protocol ID
MB-2520
Status last verified
Sep 2026
First submitted
24 Aug 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 30-30-30 PFE Intervention and Standard in people with Overweight , Obesity, run by Midwest Center for Metabolic and Cardiovascular Research at 3 sites 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 9 inclusion and 32 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 Caryn G Adams, MPH (6304696600, cwolfe@mbclinicalresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight (time frame: From week 0 to week 24). 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 NCT07789769.

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 5 Oct 2026.

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