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

April 16, 2018 updated by: Supplement Formulators, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Life Extension Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 52 days
52 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supplement Formulators, Inc.

Investigators

  • Principal Investigator: Steven Joyal, M.D., Life Extension

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Actual)

January 23, 2018

Study Completion (Actual)

March 22, 2018

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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