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

NCT ID: NCT05422391

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-07
• Study Completion Date: 2022-11-17

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.

Detailed Description

According to the US Centers for Disease Control, more than 42% of adults are classified as obese, and approximately 74% of US adults are classified as overweight (body mass index of 25.0 to < 30 kg/m2) or obese (>30 kg/m2) (Ow/Ob). The costs on human health are profound, increasing the risk of heart disease, stroke, type 2 diabetes, and certain cancers, and ultimately increasing morbidity associated with these chronic diseases. Obesity and the negative sequelae inflict staggering economic costs, estimated at $147 billion, and that was in 2008. Therefore, understanding and developing interventions that can help address Ow/Ob can reduce the risk of chronic disease, reduce healthcare costs, and likely improve quality of life.

One such intervention has been through altering diet and/or physical activity. However, prior systematic review and meta-analysis suggests that when comparing diet alone vs. exercise alone, dietary interventions result in ~3-fold greater weight loss (11 vs 3 Δkg). While the additional benefits of exercise are not be discounted, engaging dietary approaches can be a highly effective way to promote weight loss. Caloric restriction (CR) has long been touted as an effective method of inducing weight loss, although there are also issues with adherence and maintenance with such an approach. This study is seeking to understand the acute metabolic changes with engaging in a 3-day caloric restriction, which would typically be part of an intermittent fasting dietary regimen.

Specific Aim 1. Document the efficacy of the 3 day IF/CR on inducing short term weight loss, the nature of the weight loss changes (body composition), changes in anthropometrics (waist and hip circumference), changes in resting metabolic rate and changes in metabolic flexibility (relative utilization of fats versus carbohydrates).

Specific Aim 2. Explore the physiological responses to the 3 day IF/CR with the Plexus 3 day reset program through analysis of blood plasma for levels of insulin, glucose, lipid profile (total cholesterol, high- and low-density cholesterol (HDL/LDL)), pro- and anti-inflammatory mediators (Tumor Necrosis Factor-alpha, TNFa and Cortisol, respectively), ketones, thyroid stimulating hormone (TSH), and hormones related to hunger and satiety and thus energy intake (protein YY (PYY), neuropeptide Y (NPY), Ghrelin, and Leptin).

Specific Aim 3. Ascertain any possible changes in clinically relevant parameters such as heart rate, heart rate variability (HRV), blood pressure (central and peripheral), and vascular stiffness (augmentation index, AIx).

Hypothesis: The investigators hypothesize that the nutritional intervention will induce weight loss, changes in anthropometrics/body composition (i.e. decreased body water), resting metabolic rate, and alterations in metabolic flexibility. These measures will be explained, at least, in part, by alterations in specific blood biomarkers. The investigators also hypothesize that the 3 day IF/CR will result in improved indicators of cardiovascular health.

Conditions

Obesity; Overweight; Intermittent Fasting

Keywords

intermittent fasting; caloric restriction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Pre- post-dietary intervention

Single arm pre-post dietary intervention (caloric restriction)

Group Type: OTHER

3 day caloric restriction/metabolic reset

Intervention Type: 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.

Interventions

3 day caloric restriction/metabolic reset

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Skidmore College

OTHER

Sponsor Role: lead

Responsible Party

Stephen J. Ives

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Ives, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Skidmore College

Locations

Skidmore College

Saratoga Springs, New York, United States

Countries

United States

Other Identifiers

2204-1028

Identifier Type: -

Identifier Source: org_study_id