Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain
NCT ID: NCT03372109
Last Updated: 2018-04-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
23 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-11-14
Study Completion Date
2018-03-22
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.
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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.
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.
Conditions
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Body Weight Changes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
SINGLE
Participants
Study Groups
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Modified Fasting Arm
Dietary Supplements administered daily for 52 days with a meal replacement shake administered two days per week for the study duration
Group Type
ACTIVE_COMPARATOR
Meal replacement shake
Intervention Type
DIETARY_SUPPLEMENT
Meal replacement shake taken two days per week during the modified fasting periods
Multivitamin and mineral capsules
Intervention Type
DIETARY_SUPPLEMENT
Multivitamin/mineral supplement
Fish oil with sesame lignans and olive extract softgel
Intervention Type
DIETARY_SUPPLEMENT
Wild Fish Oil Concentrate 2000mg, Olive Extract 300mg, Sesame seed lignan extract 10mg/2 softgels
Prebiotic Chewable tablet
Intervention Type
DIETARY_SUPPLEMENT
Prebiotic Fiber 1,400 mg/tablet
Clove Extract and Maqui Berry extract capsule
Intervention Type
DIETARY_SUPPLEMENT
Clove extract 250mg and maqui berry extract 200mg/capsule
.Whole Food Blend capsule
Intervention Type
DIETARY_SUPPLEMENT
Whole food blend 1000mg/3 capsules
Turmeric extract capsule
Intervention Type
DIETARY_SUPPLEMENT
Turmeric 25:1 extract 400mg/capsule
European White Kidney Bean capsule
Intervention Type
DIETARY_SUPPLEMENT
White kidney bean extract 100mg/capsule
Saffron extract capsule
Intervention Type
DIETARY_SUPPLEMENT
Saffron extract 88.25mg/capsule
Ubiquinol with Fulvic acid complex softgel
Intervention Type
DIETARY_SUPPLEMENT
Ubiquinol 100mg and Fulvic Acid complex 100mg/softgel
Calcium with Hesperidin and gynostemma extract tablet
Intervention Type
DIETARY_SUPPLEMENT
Calcium 130mg. hesperidin 500mg and gynostemma extract 450mg/ tablet
Placebo
Multivitamin tablet administered daily for 52 days
Group Type
PLACEBO_COMPARATOR
Multivitamin and mineral supplement
Intervention Type
DIETARY_SUPPLEMENT
Multivitamin and multimineral supplement
Interventions
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Meal replacement shake
Meal replacement shake taken two days per week during the modified fasting periods
Intervention Type
DIETARY_SUPPLEMENT
Multivitamin and mineral capsules
Multivitamin/mineral supplement
Intervention Type
DIETARY_SUPPLEMENT
Fish oil with sesame lignans and olive extract softgel
Wild Fish Oil Concentrate 2000mg, Olive Extract 300mg, Sesame seed lignan extract 10mg/2 softgels
Intervention Type
DIETARY_SUPPLEMENT
Prebiotic Chewable tablet
Prebiotic Fiber 1,400 mg/tablet
Intervention Type
DIETARY_SUPPLEMENT
Clove Extract and Maqui Berry extract capsule
Clove extract 250mg and maqui berry extract 200mg/capsule
Intervention Type
DIETARY_SUPPLEMENT
.Whole Food Blend capsule
Whole food blend 1000mg/3 capsules
Intervention Type
DIETARY_SUPPLEMENT
Turmeric extract capsule
Turmeric 25:1 extract 400mg/capsule
Intervention Type
DIETARY_SUPPLEMENT
European White Kidney Bean capsule
White kidney bean extract 100mg/capsule
Intervention Type
DIETARY_SUPPLEMENT
Saffron extract capsule
Saffron extract 88.25mg/capsule
Intervention Type
DIETARY_SUPPLEMENT
Ubiquinol with Fulvic acid complex softgel
Ubiquinol 100mg and Fulvic Acid complex 100mg/softgel
Intervention Type
DIETARY_SUPPLEMENT
Calcium with Hesperidin and gynostemma extract tablet
Calcium 130mg. hesperidin 500mg and gynostemma extract 450mg/ tablet
Intervention Type
DIETARY_SUPPLEMENT
Multivitamin and mineral supplement
Multivitamin and multimineral supplement
Intervention Type
DIETARY_SUPPLEMENT
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
* 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
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.
* 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.
Minimum Eligible Age
21 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Supplement Formulators, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Steven Joyal, M.D.
Role: PRINCIPAL_INVESTIGATOR
LIfe Extension
Locations
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Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States
Site Status
Countries
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United States
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RESULT
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Reference Type
DERIVED
Related Links
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http://aibmr.com/gras-affirmation-and-the-development-of-functional-foods/
AIBMR.GRAS Self-determination Inventory Database. Coenzyme Q10.
https://medlineplus.gov/druginfo/meds/a607065.html
Omega-3 Fatty Acids
http://www.lifeextension.com/Vitamins-Supplements/item02114/Two-Per-Day-Capsules
Two-Per-Day capsules
Other Identifiers
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CL092
Identifier Type: -
Identifier Source: org_study_id
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