The Effects of the GOLO for Life® Plan With Release Supplement on Glycemic Control and Weight in Overweight and Obese Adults With Prediabetes or Type 2 Diabetes

Inclusion Criteria:

1. Males and females between the age of 18-75 years, inclusive, at screening

2. BMI ≥25 kg/m2

3. Females not of child-bearing potential, defined as those who have undergone asterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tuballigation, complete endometrial ablation) or have been post-menopausal for at least 1year prior to screening Or, Individuals of child-bearing potential must have a negative baseline urine pregnancytest and agree to use a medically approved method of birth control for the durationof the study. All hormonal birth control must have been in use for a minimum ofthree months prior to enrollment. Acceptable methods of birth control include:

• Hormonal contraceptives including oral contraceptives, hormone birth controlpatch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectablecontraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)

• Double-barrier method

• Intrauterine devices

• Non-heterosexual lifestyle or agrees to use contraception if planning onchanging to heterosexual partner(s)

• Vasectomy of partner at least 6 months prior to screening

• Abstinence and agrees to use contraception if planning on becoming sexuallyactive

4. Prediabetes or Type 2 Diabetes with HbA1c ≥6.0% to <9% with stability of disease andno change in diabetic medication in the past three months, if applicable.

5. Self-reported stable body weight in the three months prior to baseline, as assessedby the QI

6. Motivated and ability to comply with G4LP guidelines as assessed by aSelf-Motivation Questionnaire at screening (see Appendix 16.3)

7. Agrees to maintain current lifestyle habits as much as possible throughout the studydepending on ability to maintain the following: medications, supplements (unlessexcluded), and sleep

8. Willingness and ability to complete questionnaires, records, and diaries associatedwith the study, adhere to dietary and exercise guidelines, and to complete allclinic visits

9. Provided voluntary, written, informed consent to participate in the study

Exclusion Criteria:

1. Individuals who are pregnant, breast feeding, or planning to become pregnant duringthe study

2. Allergy, sensitivity, or intolerance to the investigational product ingredients

3. Type 1 diabetes

4. Type 2 diabetes if on insulin treatment

5. Gastric bypass surgery or other surgeries to induce weight loss

6. Current participation or participation within the last three months in any weightloss or diet programs

7. Current or history of eating disorders, as assessed by the QI

8. Obesity-induced by metabolic or endocrinologic disorders (ex. acromegaly,hypothalamic obesity), as assessed by the QI

9. Current or history of significant diseases of the gastrointestinal tract, asassessed by the QI

10. Chronic inflammatory diseases, as assessed by the QI

11. History of gout and have had a flare up within 12 months, as assessed by the QI

12. Current unstable diagnosis with kidney and/or liver diseases as assessed by the QIon a case-by-case basis, with the exception of history of kidney stones inparticipants who are symptom free for 6 months

13. Self-reported confirmation of current or pre-existing thyroid condition. Treatmenton a stable dose of medication for at least 3 months will be considered by the QI

14. Major surgery in the past 3 months or individuals who have planned surgery duringthe course of the study. Participants with minor surgery will be considered on acase-by-case basis by the QI

15. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy orradiation with a follow up that is negative. Volunteers with cancer in fullremission for more than five years after diagnosis are acceptable

16. Current use of any prescribed or over-the counter medications and/or supplementsthat may affect glycemic control, body weight, or metabolism, as assessed by the QI

17. Regular use of tobacco products within 6 months of baseline and during the studyperiod, as assessed by the QI

18. Chronic inhalation and edible use of cannabinoid products (>1 time/month).Occasional users must agree to wash out and abstain during the study period

19. Alcohol intake average of >2 standard drinks per day

20. Alcohol or drug abuse within the last 12 months

21. Clinically significant abnormal laboratory results at screening, as assessed by theQI

22. Blood donation 30 days prior to baseline, during the study, or a planned donationwithin 30 days of the last study visit

23. Participation in other clinical research studies 30 days prior to baseline, asassessed by the QI

24. Individuals who are unable to give informed consent

25. Any other condition or lifestyle factor, that, in the opinion of the QI, mayadversely affect the participant's ability to complete the study or its measures orpose significant risk to the participant