Trials / Completed
CompletedNCT03372109
Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Supplement Formulators, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-11-14
- Primary completion
- 2018-01-23
- Completion
- 2018-03-22
- First posted
- 2017-12-13
- Last updated
- 2018-04-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03372109. Inclusion in this directory is not an endorsement.