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

NCT05422391 | Completed

• 1 other identifier: 2204-1028
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Overweight; Intermittent Fasting

Keywords

intermittent fasting; caloric restriction

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Change in total body weight

  (days 0 and 4)

Secondary Outcomes (18)

• Change in total body water

  (days 0 and 4)

• Change in body fat (%)

  (days 0 and 4)

• Change in lean mass (kg)

  (days 0 and 4)

• Change in waist circumference

  (days 0 and 4)

• Change in hip circumference

  (days 0 and 4)

Study Arms (1)

Pre- post-dietary intervention

OTHER

Single arm pre-post dietary intervention (caloric restriction)

Dietary Supplement: 3 day caloric restriction/metabolic reset

Interventions

3 day caloric restriction/metabolic reset DIETARY_SUPPLEMENT

Participants will consume \~500 kcal/day, using commercially available products (Plexus(r)), for 3 days, measuring physiological relevant parameters pre-and post-intervention.

Pre- post-dietary intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight or obese (body mass index, BMI \> 27.5 kg/m2)
• Weight stable (± 4.4 lb) for \> 6 months prior
• 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.

Sponsors & Collaborators

• Skidmore College: lead

Study Sites (1)

Skidmore College

Saratoga Springs, New York, 12866, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Intermittent Fasting

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Stephen Ives, Ph.D.

  Skidmore College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study will utilize a pre-post interventional design to assess the acute effects of a 3 day caloric restriction protocol.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 16, 2022
• Study Start: June 7, 2022
• Primary Completion: September 7, 2022
• Study Completion: November 17, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)