Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety

This randomized, two-period crossover study will include one screening/baseline visit (visit
1) and two 24-h treatment periods (treatment period 1: visits 2 and 3 and treatment period 2:
visits 4 and 5). A minimum 7-d washout will occur between the treatment periods.

Inclusion Criteria:

1. Subject is a male or female, 18-74 years of age, inclusive.

2. Subject has a BMI of ≥27.0-39.99 kg/m2 at visit 1.

3. Subject has a waist circumference ≥40 in for men and ≥35 in for women at visit 1.

4. Subject has a rating of 7 to 10 on the Vein Access Scale at visit 1 (Appendix 2).

5. Subject is willing to maintain a stable body weight and follow his/her habitual diet
and physical activity patterns throughout the trial, except for the substitution of
the study foods.

6. Subject is willing to consume the study foods provided throughout the duration of the
study.

7. Subject has no plans to change smoking habits or other nicotine use during the study
period and is willing to refrain from nicotine use for 1 h prior to and during all
test visits.

8. Subject is willing to refrain from alcohol and vigorous physical activity 24 hours
prior to test days (visits 2, 3, 4 and 5).

9. Subject is judged by the Investigator to be in general good health on the basis of
medical history.

10. Subject 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 and is willing to complete study procedures.

Exclusion Criteria:

1. Subject has a fasting capillary glucose of ≥126 mg/dL and/or a HbA1C ≥6.5 % based on
the capillary blood draw at visit 1.

2. Subject has a history or presence of atherosclerotic cardiovascular disease, chronic
inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis),
or clinically important endocrine (including type 1 or type 2 diabetes mellitus),
pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic,
dermatologic, neurologic, psychiatric, or biliary disorders.

3. Subject has a history of cancer in the prior 5 years, except for non-melanoma skin
cancer.

4. Subject has experienced a change in body weight of ±4.5 kg (10 lbs) over the 3 months
prior to visit 1.

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

6. Subject has uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP

- 100 mm Hg) at visit 1.

7. Subject has unstable use of any antihypertensive medication within 4 weeks prior to
visit 1. Unstable use is defined as initiation or dose alteration.

8. Subject has used any of the following medications within 4 weeks of visit 1:

1. With the exception of the stable use of statins (defined as no initiation or dose
alteration within 4 weeks of visit 1) any medications intended to alter the lipid
profile, including but not limited to: bile acid sequestrants, cholesterol
absorption inhibitor, fibrates, niacin (drug form), omega-3-ethyl ester drugs,
and/or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.

2. Medications known to significantly influence carbohydrate metabolism, including,
but not limited to, adrenergic receptor blockers, diuretics, and/or hypoglycemic
medications.

3. Weight-loss drugs (including over-the-counter medications) or weight loss
programs.

4. Systemic corticosteroid drugs.

9. Subject has used any of the following foods or dietary supplements within 2 weeks of
visit 1:

1. Food/supplements known to influence lipid metabolism, including, but not limited
to, omega-3 fatty acid supplements (e.g., flaxseed, fish or algal oils) or
fortified foods, sterol/stanol products; dietary supplements (red rice yeast
supplements; garlic supplements; soy isoflavone supplements; niacin or its
analogues at doses >400 mg/d (or others at the discretion of the Investigator).

2. Irregular or inconsistent use of Metamucil® or other viscous fiber-containing
supplements (consistent, daily use up to 1 tsp of a viscous-fiber supplement is
acceptable).

10. Subject has used antibiotics within 5 days of any clinic visit: For those with an
active infection and/or using antibiotics, subjects must wait at least 5 d after the
infection resolves or antibiotic use is complete. The test period will be extended for
study completion in these cases.

11. 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.

12. Subject has extreme dietary habits (e.g. very low CHO diet, vegan, etc.).

13. Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa,
or binge eating) diagnosed by a health professional.

14. Subject is a habitual breakfast skipper (defined as skipping breakfast ≥4 times per
week).

15. Subject has a current or recent history (past 12 months), or strong potential, for
drug or alcohol abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12
oz beer, 5 oz wine, or 1 ½ oz distilled spirits).

16. Subject has been exposed to any non-registered drug product within 30 days of visit 1.

17. Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent or comply with the study protocol, or which might
confound the interpretation of the study results or put the person at undue risk.