The Acute Effects of Caloric Restriction on Anthropometrics, Metabolism, and Cardiovascular Health in Overweight Adults

Completed · Not applicable

Conditions studied: Obesity, Overweight, Intermittent Fasting

In brief

The purpose of this study is to document the efficacy of a 3 day intermittent fasting/caloric restriction (IF/CR) using the Plexus® 3 day reset program on body weight as well as regulatory parameters of metabolism and metabolic flexibility. This study will provide data on the acute efficacy regarding the program but also identify the potential underlying physiological mechanisms through which the dietary intervention may elicit improvements, and the participant experience of the program. Collectively, this will provide a window into the possible adaptations with a longer-term dietary intervention.

Key facts

Study ID

NCT05422391

Run by

Skidmore College

People needed

15

Starts

2022-06-07

Expected to finish

2022-11-17

Last updated by the study team

2022-12-13

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Overweight or obese (body mass index, BMI > 27.5 kg/m2)
• Weight stable (± 4.4 lb) for > 6 months prior
• 25 to 65 years of age
• Participants will be expected to be otherwise relatively healthy without uncontrolled chronic disease (e.g. cardiovascular, metabolic, or pulmonary) and 2 or fewer positive risk factors for cardiovascular disease (CVD) (e.g. high blood pressure, high cholesterol, etc) as described by the American College of Sports Medicine (ACSM)/American Heart Association (AHA) Criteria.
• Cleared by Physician

You may not qualify if…

• Subjects who present with more than 2 CVD risk factors (AHA/ACSM criteria) or have uncontrolled/overt cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus)
• Not cleared by their physician.
• Recent blood donation (<8 weeks)
• Those who have cancer or are being treated for cancer.
• Women who are currently pregnant, breastfeeding, attempting to conceive, or amenorrheic (not associated with menopause).
• Anyone who presents with food allergies to coconuts, dairy, soy, stevia, or nuts will also be excluded.
• Those with eating disorders should not partake in this study.

Where it is running

• Skidmore College — Saratoga Springs, New York, United States

Full record on ClinicalTrials.gov

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