Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial to Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain in Overweight But Generally Healthy Adults Over the Winter Holiday Period

Conditions
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Body Weight Changes

Intervention / Treatment
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* Dietary Supplement: Meal replacement shake
* Dietary Supplement: Multivitamin and mineral capsules
* Dietary Supplement: Fish oil with sesame lignans and olive extract softgel
* Dietary Supplement: Prebiotic Chewable tablet
* Dietary Supplement: Clove Extract and Maqui Berry extract capsule
* Dietary Supplement: .Whole Food Blend capsule
* Dietary Supplement: Turmeric extract capsule
* Dietary Supplement: European White Kidney Bean capsule
* Dietary Supplement: Saffron extract capsule
* Dietary Supplement: Ubiquinol with Fulvic acid complex softgel
* Dietary Supplement: Calcium with Hesperidin and gynostemma extract tablet
* Dietary Supplement: Multivitamin and mineral supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory, male or female, 21-65 years of age A body mass index (BMI) of 23-34.9 Generally healthy and having no significant difficulty with digestion of food Has been generally weight stable for the past six months Willing to discontinue use of any (non-study) multivitamin or Vitamin D supplements during the study Willing and able to give written informed consent Clearly understands the procedures and study requirements Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol Able to communicate, including reading, in English Primary Exclusion Criteria: Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug in the past 30 days History of allergy or sensitivity to any component of the study products including milk, soy and almonds Donation of blood with 30 days prior to screening/baseline Inability to provide a venous blood sample Participation in another study within 30 days prior to baseline/screening Being pregnant or planning on becoming pregnant during study participation; or breast feeding Having been diagnosed, received medical treatment or taking medication daily for the following medical condition(s): Diabetes mellitus Eating disorder Acute or chronic inflammatory disease or autoimmune disease Cardiovascular disease Gastrointestinal disease including gallbladder problems, gallstones or biliary tract obstruction Thyroid disease (unless on a stable dose of medication for 3 months prior to screening and unlikely to change medication or dose during the study) Hypertension (unless on a stable dose of medication for 3 months prior to screening and unlikely to change medication or dose during the study) Psychiatric disorder Neurologic condition/disease Cancer (unless skin cancer other than melanoma which has been treated > 3 years prior to Baseline/screening) Active or chronic liver, pancreatic and kidney disease Blood coagulation disorder Other condition or medication use that would preclude participation in the study in the judgment of the investigator/sub-investigator (Sub-I) Currently taking or having taken within the 30 days prior to screening/baseline any hormone replacement therapy (including DHEA (dehydroepiandrosterone), estrogen, progesterone, or testosterone; except those utilized as a method of birth control and which have been taken for > 3 months, with no anticipated change for the duration of the study) Currently taking any of the nutritional supplements used in the study and unwilling to discontinue use at least 14 days prior to screening. Currently taking a medication or nutritional supplement specifically for weight loss and unwilling to discontinue use 14 days prior to the first dosing of study supplements Currently participating in a weight loss program and unwilling to discontinue participation prior to enrollment into the study Currently taking an anti-coagulant, anti-platelet medication or a glucose lowering medication Having had a surgical procedure or having an internal medical device which, in the judgment of the PI/Sub-I, would preclude participation in the study Having abnormal screening laboratory test values including bilirubin > 2.5 x ULN (upper limit of normal), AST/SGOT(aspartate aminotransferase/serum glutamin oxaloacetic transaminase) and ALT/SGPT (alanine aminotransferase/serum glutamic pyruvic transaminase) > 2.5 x ULN, serum creatinine > 1.5 mg/dL, blood glucose < 85 mg/dL or > 125 mg/dL, and TSH(thyroid stimulating hormone) > 4.12 µIU/mL, or other lab test result(s) that would preclude study participation in the judgement of the PI/Sub-I Having blood pressure readings at Baseline/screening > 140 systolic or > 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the PI/Sub-I Currently consumes more than 7 standard alcoholic drinks per week for women and 14 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor) Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos Having any other circumstance that precludes study participation in the judgment of the PI/Sub-I including use of other nutritional supplements which will be evaluated on a case-by-case basis.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified Fasting Arm<br>Dietary Supplements administered daily for 52 days with a meal replacement shake administered two days per week for the study duration | Dietary Supplement: Meal replacement shake<br>* Meal replacement shake taken two days per week during the modified fasting periods<br>Dietary Supplement: Multivitamin and mineral capsules<br>* Multivitamin/mineral supplement<br>Dietary Supplement: Fish oil with sesame lignans and olive extract softgel<br>* Wild Fish Oil Concentrate 2000mg, Olive Extract 300mg, Sesame seed lignan extract 10mg/2 softgels<br>Dietary Supplement: Prebiotic Chewable tablet<br>* Prebiotic Fiber 1,400 mg/tablet<br>Dietary Supplement: Clove Extract and Maqui Berry extract capsule<br>* Clove extract 250mg and maqui berry extract 200mg/capsule<br>Dietary Supplement: .Whole Food Blend capsule<br>* Whole food blend 1000mg/3 capsules<br>Dietary Supplement: Turmeric extract capsule<br>* Turmeric 25:1 extract 400mg/capsule<br>Dietary Supplement: European White Kidney Bean capsule<br>* White kidney bean extract 100mg/capsule<br>Dietary Supplement: Saffron extract capsule<br>* Saffron extract 88.25mg/capsule<br>Dietary Supplement: Ubiquinol with Fulvic acid complex softgel<br>* Ubiquinol 100mg and Fulvic Acid complex 100mg/softgel<br>Dietary Supplement: Calcium with Hesperidin and gynostemma extract tablet<br>* Calcium 130mg. hesperidin 500mg and gynostemma extract 450mg/ tablet<br>|
| Placebo Comparator: Placebo<br>Multivitamin tablet administered daily for 52 days | Dietary Supplement: Multivitamin and mineral supplement<br>* Multivitamin and multimineral supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 52 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hs-CRP | hs-C-reactive protein | 52 days | 
| IL-6 | Interleukin-6 | 52 days | 
| IL-8 | Interleukin-8 | 52 days | 
| IL-12 | Interleukin-12 | 52 days | 
| TNF-a | Tumor necrosis factor alpha | 52 days | 
| IGF-1 | Insulin-like growth factor 1 | 52 days | 
| IGFBP-1 | Insulin-like growth factor binding protein 1 | 52 days | 
| Total Cholesterol |  | 52 days | 
| LDL-c | LDL Cholesterol | 52 days | 
| HDL-c | HDL Cholesterol | 52 days | 
| Glucose |  | 52 days | 
| Triglycerides |  | 52 days | 
| Insulin |  | 52 days | 
| Vitamin D, 25-Hydroxy |  | 52 days | 
| Percent body fat |  | 52 days | 
| Waist circumference |  | 52 days |