The purpose of this study is to assess the effects of repeated periods of modified fasting in support of healthy weight management and prevention of weight gain over the winter holiday period (mid-November to early January) in comparison to regular diet and activity.
This study is a randomized, placebo-controlled trial in which subjects assigned to the modified fasting cohort will undergo consecutive weekly cycles of modified fasting for two consecutive days. The primary objective is to assess the effects of repeated periods of modified fasting on body weight. The secondary objectives include assessment of the effects of modified fasting on percent body fat, waist circumference and fasting levels of hs-CRP (hs-C-reactive protein), IL-6 (Interleukin-6), IL-8 (interleukin-8), IL-12 (interleukin-12), TNF-a (tumor necrosis factor-alpha), IGF-1 (insulin-like growth factor 1), IGFBP-1 (insulin-like growth factor-binding protein 1) , Total Cholesterol, LDL cholesterol, HDL cholesterol, Glucose, Triglyceride, Insulin, Vitamin-D, 25-Hydroxy, Participants will undergo assessments of blood tests, vital signs, BMI, body weight, waist circumference and percent body fat.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
23
Meal replacement shake taken two days per week during the modified fasting periods
Multivitamin/mineral supplement
Wild Fish Oil Concentrate 2000mg, Olive Extract 300mg, Sesame seed lignan extract 10mg/2 softgels
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States
Body weight
Time frame: 52 days
hs-CRP
hs-C-reactive protein
Time frame: 52 days
IL-6
Interleukin-6
Time frame: 52 days
IL-8
Interleukin-8
Time frame: 52 days
IL-12
Interleukin-12
Time frame: 52 days
TNF-a
Tumor necrosis factor alpha
Time frame: 52 days
IGF-1
Insulin-like growth factor 1
Time frame: 52 days
IGFBP-1
Insulin-like growth factor binding protein 1
Time frame: 52 days
Total Cholesterol
Time frame: 52 days
LDL-c
LDL Cholesterol
Time frame: 52 days
HDL-c
HDL Cholesterol
Time frame: 52 days
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Prebiotic Fiber 1,400 mg/tablet
Clove extract 250mg and maqui berry extract 200mg/capsule
Whole food blend 1000mg/3 capsules
Turmeric 25:1 extract 400mg/capsule
White kidney bean extract 100mg/capsule
Saffron extract 88.25mg/capsule
Ubiquinol 100mg and Fulvic Acid complex 100mg/softgel
Calcium 130mg. hesperidin 500mg and gynostemma extract 450mg/ tablet
Multivitamin and multimineral supplement
Glucose
Time frame: 52 days
Triglycerides
Time frame: 52 days
Insulin
Time frame: 52 days
Vitamin D, 25-Hydroxy
Time frame: 52 days
Percent body fat
Time frame: 52 days
Waist circumference
Time frame: 52 days