The Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat Loss
The Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat Loss
The objective of this study is to investigate the effect of a high protein, high fiber
 dietary supplement on weight and fat loss in healthy overweight adults. Half of participants
 will receive a high protein, high fiber supplement twice a day for 12 weeks, and half of the
 subjects will receive a placebo (that contains the same amount of calories as the supplement)
 twice a day for 12 weeks.
Inclusion Criteria:

 1. Male or female of 25-50 years of age

 2. If female, the subject is not of child bearing potential, which is defined as females
 who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are
 post-menopausal (natural or surgically with > 1 year since last menstruation) OR

 Females of childbearing potential must agree to use a medically approved method of
 birth control and have a negative urine pregnancy test result at screening. Acceptable
 methods of birth control include:

 -  Hormonal contraceptives including oral contraceptives, hormone birth control
 patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable
 contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) for
 at least 3 months

 -  Double-barrier method

 -  Non-hormonal IUDs

 -  Hormonal IUD methods must be a stable dose for at least 3 months

 -  Vasectomy of partner

 -  Non-heterosexual lifestyle

 3. A BMI between 27.0 - <35.0 kg/m2 (inclusive). Subjects must meet exactly the inclusion
 BMI at screening, or be screen failed. Subjects who meet the BMI requirement at
 screening and present at run-in with a BMI of <27.0 or >35 kg/m2 will be counselled.

 4. Subjects that have had a stable weight for the past 6 months. A stable weight is
 defined as not having gained or lost more than 5 kg of body weight throughout the past
 6 months (cycling of weight, for example, continuously up and down anything less than
 5 kg is considered stable)

 5. Agreement to comply with dietary recommendations from nutritionist throughout the
 duration of the study that include a 500 kcal energy deficit from their predicted
 total energy requirements

 6. Agrees to fully comply with all study procedures

 7. Has given voluntary written and informed consent to participate in the study

 8. Determined to be healthy as per laboratory parameters and physical examination

 Exclusion Criteria:

 1. Females who are pregnant, breastfeeding or planning to become pregnant during the
 course of the study

 2. Subjects who are smokers (tobacco, e-cigarettes) or have been a smoker within the past
 1 year from screening

 3. Individuals who carry an epi-pen, or those with a diagnosed allergy or who believe
 that they have an allergy to milk or milk products, crustacean shellfish, tree nuts,
 or peanuts

 4. Individuals with a severe allergy to egg, fish, wheat or soy ingredients as the
 product is manufactured in a facility that contains these ingredients

 5. The use of prescription, over-the-counter health products, or natural health
 products/dietary supplements being taken for weight loss, cholesterol levels, or blood
 pressure within 4 weeks of screening

 6. Subjects with a history of eating disorders

 7. Current participation or participation within the last 3 months in any weight loss
 program or diet (for example Weight Watchers, Jenny Craig, DASH diet, Atkins,
 Mediterranean etc.)

 8. Medical history of thyroid disorders except for subjects diagnosed with hypothyroid
 and have been on stable medication for at least the last 3 months prior to enrollment.
 All subject with medical history of hyperthyroid are excluded

 9. Medical history of hypercholesterolipidemia

 10. Use of cholesterol lowering prescription drugs within the last 6 months

 11. Fasting TGs ≥ 200 mg/dL (2.26 mmol/L) or a fasting total cholesterol ≥ 240 mg/dL
 (6.216 mmol/L)

 12. Fasting glucose ≥ 126 mg/dL

 13. Hypertension defined as untreated systolic blood pressure >160 mmHg, diastolic blood
 pressure >100 mmHg, or the use of prescription high blood pressure/hypertension
 medications within the last 6 months

 14. Type I or Type II diabetes or use of diabetes medication in a preventative setting.

 15. History of gastrointestinal dysfunction or surgery that may influence digestion or
 absorption

 16. Chronic inflammation or structural abnormality, including history of, of the digestive
 tract (inflammatory bowel disease, celiac disease, chronic diarrhea, chronic
 constipation, duodenal or gastric ulcer, gastric retention or obstruction,
 Gastroesophageal reflux disease (GERD), or symptomatic cholelithiasis)

 17. Subjects who have a history of colorectal cancer, bowel resection, rectocele, or
 colostomy

 18. Immunocompromised individuals such as subjects that have undergone organ
 transplantation, those with rheumatoid arthritis, or subjects diagnosed with human
 immunodeficiency virus (HIV)

 19. Unstable medical conditions that in the opinion of the Qualified Investigator preclude
 the subject from participating in the study

 20. Anti-anxiety and anti-psychotic medications will be assessed by the MD on a case by
 case basis

 21. Alcohol use > 2 standard alcoholic drinks per day

 22. Alcohol or drug abuse within the last 6 months

 23. Use of medicinal marijuana

 24. Cancer, except skin cancers completely excised with no chemotherapy or radiation with
 a follow up that is negative

 25. Subjects with metal fixation plates or screws from a previous surgery

 26. Clinically significant abnormal laboratory results at screening

 27. Participation in a clinical research trial within 30 days prior to randomization

 28. Allergy or sensitivity to study supplement ingredients

 29. Individuals who are cognitively impaired and/or who are unable to give informed
 consent

 30. Any other condition which in the Investigator's opinion may adversely affect the
 subject's ability to complete the study or its measures or which may pose significant
 risk to the subject

 31. Unwilling or unable to comply with study timeline and procedures

 32. Individuals who do not like the taste of chocolate or shake type drinks