Status
Conditions
Treatments
About
The objective of this study is to assess whether intake of baked and then chilled potatoes over a 24-h period, compared to intake of isocaloric, carbohydrate (CHO)-matched foods low in fiber and resistant starch (RS), will increase insulin sensitivity, breath hydrogen and satiety, and decrease hunger and free fatty acid (FFA) levels in overweight or obese men and women at risk for metabolic syndrome and diabetes mellitus.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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.
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.
Subject has a history of cancer in the prior 5 years, except for non-melanoma skin cancer.
Subject has experienced a change in body weight of ±4.5 kg (10 lbs) over the 3 months prior to visit 1.
Subject has a known allergy, sensitivity, or intolerance to any ingredients in the study foods.
Subject has uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP
Subject has unstable use of any antihypertensive medication within 4 weeks prior to visit 1. Unstable use is defined as initiation or dose alteration.
Subject has used any of the following medications within 4 weeks of visit 1:
Subject has used any of the following foods or dietary supplements within 2 weeks of visit 1:
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.
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.
Subject has extreme dietary habits (e.g. very low CHO diet, vegan, etc.).
Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
Subject is a habitual breakfast skipper (defined as skipping breakfast ≥4 times per week).
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).
Subject has been exposed to any non-registered drug product within 30 days of visit 1.
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.
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal