Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain
Completed · Not applicable · Has a placebo group
Conditions studied: Body Weight Changes
In brief
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.
Key facts
- Study ID
- NCT03372109
- Run by
- Supplement Formulators, Inc.
- People needed
- 23
- Starts
- 2017-11-14
- Expected to finish
- 2018-03-22
- Last updated by the study team
- 2018-04-17
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
Where it is running
- Life Extension Clinical Research, Inc. — Fort Lauderdale, Florida, United States
Full record on ClinicalTrials.gov
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