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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Weight Changes
- Sponsor
- Supplement Formulators, Inc.
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Body weight
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Body weight
Time Frame: 52 days
Secondary Outcomes
- hs-CRP(52 days)
- IL-6(52 days)
- IL-8(52 days)
- IL-12(52 days)
- TNF-a(52 days)
- IGF-1(52 days)
- IGFBP-1(52 days)
- Total Cholesterol(52 days)
- LDL-c(52 days)
- HDL-c(52 days)
- Glucose(52 days)
- Triglycerides(52 days)
- Insulin(52 days)
- Vitamin D, 25-Hydroxy(52 days)
- Percent body fat(52 days)
- Waist circumference(52 days)