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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.

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.

Condition or disease Intervention/treatment Phase
Body Weight Changes 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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: 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
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : January 23, 2018
Actual Study Completion Date : March 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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
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

Placebo Comparator: Placebo
Multivitamin tablet administered daily for 52 days
Dietary Supplement: Multivitamin and mineral supplement
Multivitamin and multimineral supplement




Primary Outcome Measures :
  1. Body weight [ Time Frame: 52 days ]

Secondary Outcome Measures :
  1. hs-CRP [ Time Frame: 52 days ]
    hs-C-reactive protein

  2. IL-6 [ Time Frame: 52 days ]
    Interleukin-6

  3. IL-8 [ Time Frame: 52 days ]
    Interleukin-8

  4. IL-12 [ Time Frame: 52 days ]
    Interleukin-12

  5. TNF-a [ Time Frame: 52 days ]
    Tumor necrosis factor alpha

  6. IGF-1 [ Time Frame: 52 days ]
    Insulin-like growth factor 1

  7. IGFBP-1 [ Time Frame: 52 days ]
    Insulin-like growth factor binding protein 1

  8. Total Cholesterol [ Time Frame: 52 days ]
  9. LDL-c [ Time Frame: 52 days ]
    LDL Cholesterol

  10. HDL-c [ Time Frame: 52 days ]
    HDL Cholesterol

  11. Glucose [ Time Frame: 52 days ]
  12. Triglycerides [ Time Frame: 52 days ]
  13. Insulin [ Time Frame: 52 days ]
  14. Vitamin D, 25-Hydroxy [ Time Frame: 52 days ]
  15. Percent body fat [ Time Frame: 52 days ]
  16. Waist circumference [ Time Frame: 52 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372109


Locations
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United States, Florida
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States, 33308
Sponsors and Collaborators
Supplement Formulators, Inc.
Investigators
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Principal Investigator: Steven Joyal, M.D. LIfe Extension

Additional Information:
Publications of Results:
Other Publications:
Bitler C, Matt K, Irving M, et al. Olive extract supplement decreases pain and improves daily activities in adults with osteoarthritis and decreases plasma homocysteine in those with rheumatoid arthritis. Nutrition Research. 27(8):470-77.2007
Chen HH, Chen YK, Chang HC, et al. Immunomodulatory Effects of Xylooligosaccharides. Food Science and Technology Research. 18(2):195-9. 2012.
Coles, L.S., and Harris, S.B. Co Q-10 and lifespan extension, in: Advances in Anti-Aging Medicine, Vol 1, by R. Klatz, Mary Ann Liebert, Inc., Larchmont, New York, 1996
Mace, A.E. (1964), Sample Size Determination, New York: Reinhold Publishing Corporation
Mishra R, Joshi D. Jiao Gu Lan (Gynostemma pentaphyllum): The Chinese Rasayan-Current Research Scenario. International Journal of Research in Pharmaceutical and Biomedical Sciences. 2(4): 1483-1502, 2011.
Razmovski-Naumovski V, Hsun-Wei Huang T, Tran V, et al. Chemistry and pharmacology of Gynostemma pentaphyllum. Phytochemistry Reviews 4:197-219, 2005
Renny RM, Gopakumar G, Mohanan R, et al. Clove bud polyphenols (Clovinol®) reduces hangover and helps faster clearance of acetaldehyde by maintaining endogenous antioxidants and reducing inflammation: A randomized, double-blind, placebo-controlled crossover study. Under Review - Pharmacology Biochemistry & Behavior. 2016.
Wu X, Xiaofeng X, Shen J, Perricone NV, Preuss HG. Enhanced weight loss from a dietary supplement containing standardized Phaseolus vulgaris extract in overweight men and women. Methods (San Diego, Calif.). 12(13):15-22. 2010.
Xiao L, Ning J, Xu G. Application of Xylo-oligosaccharide in modifying human intestinal function. African Journal of Microbiology Research. (9):2116-9, 2012.

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Responsible Party: Supplement Formulators, Inc.
ClinicalTrials.gov Identifier: NCT03372109     History of Changes
Other Study ID Numbers: CL092
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Turmeric extract
Body Weight
Weight Gain
Body Weight Changes
Signs and Symptoms
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents