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Trial record 14 of 79 for:    Supplement | Turmeric

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

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ClinicalTrials.gov Identifier: NCT03372109
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Supplement Formulators, Inc.

Tracking Information
First Submitted Date  ICMJE December 7, 2017
First Posted Date  ICMJE December 13, 2017
Last Update Posted Date April 17, 2018
Actual Study Start Date  ICMJE November 14, 2017
Actual Primary Completion Date January 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
Body weight [ Time Frame: 52 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03372109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • hs-CRP [ Time Frame: 52 days ]
    hs-C-reactive protein
  • IL-6 [ Time Frame: 52 days ]
    Interleukin-6
  • IL-8 [ Time Frame: 52 days ]
    Interleukin-8
  • IL-12 [ Time Frame: 52 days ]
    Interleukin-12
  • TNF-a [ Time Frame: 52 days ]
    Tumor necrosis factor alpha
  • IGF-1 [ Time Frame: 52 days ]
    Insulin-like growth factor 1
  • IGFBP-1 [ Time Frame: 52 days ]
    Insulin-like growth factor binding protein 1
  • Total Cholesterol [ Time Frame: 52 days ]
  • LDL-c [ Time Frame: 52 days ]
    LDL Cholesterol
  • HDL-c [ Time Frame: 52 days ]
    HDL Cholesterol
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain
Official Title  ICMJE 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
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Body Weight Changes
Intervention  ICMJE
  • Dietary Supplement: Meal replacement shake
    Meal replacement shake taken two days per week during the modified fasting periods
  • Dietary Supplement: Multivitamin and mineral capsules
    Multivitamin/mineral supplement
  • 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
  • Dietary Supplement: Prebiotic Chewable tablet
    Prebiotic Fiber 1,400 mg/tablet
  • Dietary Supplement: Clove Extract and Maqui Berry extract capsule
    Clove extract 250mg and maqui berry extract 200mg/capsule
  • Dietary Supplement: .Whole Food Blend capsule
    Whole food blend 1000mg/3 capsules
  • Dietary Supplement: Turmeric extract capsule
    Turmeric 25:1 extract 400mg/capsule
  • Dietary Supplement: European White Kidney Bean capsule
    White kidney bean extract 100mg/capsule
  • Dietary Supplement: Saffron extract capsule
    Saffron extract 88.25mg/capsule
  • Dietary Supplement: Ubiquinol with Fulvic acid complex softgel
    Ubiquinol 100mg and Fulvic Acid complex 100mg/softgel
  • Dietary Supplement: Calcium with Hesperidin and gynostemma extract tablet
    Calcium 130mg. hesperidin 500mg and gynostemma extract 450mg/ tablet
  • Dietary Supplement: Multivitamin and mineral supplement
    Multivitamin and multimineral supplement
Study Arms  ICMJE
  • Active Comparator: Modified Fasting Arm
    Dietary Supplements administered daily for 52 days with a meal replacement shake administered two days per week for the study duration
    Interventions:
    • 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
  • Placebo Comparator: Placebo
    Multivitamin tablet administered daily for 52 days
    Intervention: Dietary Supplement: Multivitamin and mineral supplement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2017)
23
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 22, 2018
Actual Primary Completion Date January 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03372109
Other Study ID Numbers  ICMJE CL092
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Supplement Formulators, Inc.
Study Sponsor  ICMJE Supplement Formulators, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven Joyal, M.D. LIfe Extension
PRS Account Supplement Formulators, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP