Clinical trial Recruiting at 3 sites Interventional Ages 18 to 69

30-30-30 weight loss plan tested online with protein, fiber, and exercise

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

Run by Midwest Center for Metabolic and Cardiovascular Research · NCT07789769 · Data updated 2026-11-12

This online weight loss program tests whether the 30-30-30 plan helps people lose weight better than an online program alone for adults aged 18 to 69 with BMI 27–45.

More Overweight , Obesity trials

Quick facts

Study typeInterventional
Ages18 Years to 69 Years
SexAll
Enrollment110 (estimated)
SponsorMidwest Center for Metabolic and Cardiovascular Research
Academic / other
Locations3 sites (Addison, Illinois and 2 other locations)
StatusRecruiting
StartedSeptember 23, 2026
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedOctober 5, 2026
Trial IDNCT07789769 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–69 with BMI 27–45 kg/m2 who want to lose weight, speak English, own a Bluetooth smartphone, and can commit to a 6-month online program with virtual meetings.

Probably not a fit

Individuals who do not respond to the program or who face barriers to online engagement may not experience additional benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two online weight loss programs: the 30-30-30 plan (emphasizing protein, dietary fiber, and exercise goals) plus standard online content versus a standard online program alone. Eligible participants are adults 18–69 with obesity or overweight and a BMI between 27 and 45 kg/m2, who have an energy need of at least 1800 kcal/day and access to a compatible smartphone and internet. Participants will follow the assigned program for 6 months, engage in virtual meetings, and work toward prescribed diet and exercise targets. The trial will measure weight loss and health-related markers to determine whether the enhanced plan provides additional benefit. Lead sponsor is the Midwest Center for Metabolic and Cardiovascular Research, with collaboration from the National Cattlemen's Beef Association, and sites in Illinois and Indiana.

Why it matters

Potential benefit: If successful, participants may achieve greater weight loss and improvements in health markers through the enhanced online program.

How similar studies have gone: Other online weight loss programs with behavioral and dietary components have shown weight loss benefits; this plan adds a specific 30-30-30 structure, which is being tested here for additional gains.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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).
* 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.

Where it's running

  • Biofortis Clinical Research
    Addison, Illinois, United States
    Recruiting
  • Illinois Institute of Technology
    Chicago, Illinois, United States
    Recruiting
  • Indiana University
    Bloomington, Indiana, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.