Clinical trial: Study to Evaluate Effects of a Weight Loss Program in Different Formats on Healthy Adults (NCT03017443)

Eligibility criteria:
Inclusion Criteria:

          1. Subject is male or female, 18-70 years of age, inclusive.

          2. Subject has a body mass index (BMI) of 25.00 to 44.99 kg/m2, inclusive, at visits 1
             and 2 (weeks -1 and 0).

          3. Subject has no plans to change smoking habits during the study period.

          4. Subject is willing to follow study program instructions, including avoidance of all
             non-study-related food and beverages.

          5. Subject is willing and able to comply with the visit schedule [i.e., no visit window
             will be allowed between visits 2 and 3 (week 0 and 1) and visits 3 and 4 (weeks 1 and
             2)].

          6. Subject agrees to follow the physical activity recommendations as outlined in each
             plan.

          7. If a premenopausal female, subject has a history of regular menstrual cycles that
             range in length from 21 to 35 d, where applicable.

          8. Judged to be in good health on the basis of medical history and screening laboratory
             assessments.

          9. Subject understands the study procedures and signs forms providing informed consent to
             participate in the study and authorization for release of relevant protected health
             information to the study Investigators.

        Exclusion Criteria:

          1. Subject has an abnormal laboratory test result of clinical significance at visit 1
             (week -1), at the discretion of the Investigator. One re-test will be allowed on a
             separate day prior to visit 2 (week 0) for subjects with abnormal laboratory test
             results.

          2. Subject has had a weight loss or gain ≥10 lb (4.5 kg) in the 6 months prior to visit 1
             (week -1).

          3. Subject has used weight loss medications within 6 months of visit 1 (week -1) or
             weight loss supplements or programs, other than those provided, intended to alter body
             weight within 4 weeks of visit 1 (week -1) or during the course of the study (Appendix
             1).

          4. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian),
             in the opinion of the Investigator.

          5. Subject has a known allergy, sensitivity, or intolerance to the study foods or any
             ingredients of the study menu provided.

          6. Subject has diagnosed diabetes mellitus (type 1 or type 2) or fasting glucose ≥126
             mg/dL at the screening visit (visit 1, week -1).

          7. Subject has used thyroid hormones, except stable-dose replacement therapy for ≥2
             months prior to visit 1 (week -1; Appendix 1).

          8. Subject has used dietary supplements that, in the judgment of the Investigator, are
             likely to markedly affect appetite. The washout period will be 2 weeks prior to visit
             1 (week -1; Appendix 1).

          9. Subject has used medications or supplements that may influence carbohydrate
             metabolism, including but not limited to hypoglycemic medications and systemic
             (intravenous, intramuscular, or oral) or ≥1500 µg/d topical (inhaled, intranasal, or
             dermal) corticosteroids within 4 weeks of visit 1 (week -1) and throughout the study
             (Appendix 1).

         10. Subject has a history or presence of clinically important cardiac, renal, hepatic,
             endocrine, pulmonary, biliary, pancreatic, or neurologic disorders.

         11. Subject has an active gastrointestinal disorder such as peptic ulcer disease or
             malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases
             are acceptable).

         12. Subject has an active infection or signs/symptoms of an infection. The baseline visit
             (visit 2, week 0) will be re-scheduled to allow subject to be symptom-free of any type
             of systemic infection for at least 5 days.

         13. Subject has a history of gastrointestinal surgery for weight reducing purposes.

         14. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic
             blood pressure ≥100 mm Hg as defined by the blood pressure measured at visit 1 (week
             -1). One re-test will be allowed on a separate day prior to visit 2 (week 0) for
             subjects whose blood pressure exceeds either of these cut points at visit 1.

         15. Subject has a history or presence of cancer in the prior 2 years, except for
             non-melanoma skin cancer.

         16. Subject is a female who is pregnant, planning to be 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. The method of
             contraception must be recorded in the source document.

         17. Subject is a premenopausal female using a form of hormonal contraception that does not
             result in a normal menstrual cycle, including a regular menses period.

         18. Subject has a recent history of (within 12 months of visit 1, week -1) or strong
             potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week
             (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).

         19. Exposure to any non-registered drug product within 30 d prior to the screening visit
             (visit 1).

         20. Individual has a condition the Investigator believes would interfere with his or her
             ability to provide informed consent, comply with the study protocol, or which might
             confound the interpretation of the study results or put the person at undue risk.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? 0