Clinical trial NCT05422391: The Acute Effects of Caloric Restriction on Anthropometrics, Metabolism, and Cardiovascular Health in Overweight Adults
Official title: Evaluating the Short-Term Effects of 3 Days of Caloric Restriction/Intermittent Fasting Using the Plexus(R) Program on Anthropometrics, Metabolism, Markers of Cardiovascular Health in Overweight/Obese Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Intermittent Fasting
Keywords: intermittent fasting
caloric restriction
Lead sponsor: Skidmore College
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will utilize a pre-post interventional design to assess the acute effects of a 3 day caloric restriction protocol.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in body weight
timeFrame: (days 0 and 4)
Secondary outcomes:
measure: Change in total body water
timeFrame: (days 0 and 4)
measure: Change in body fat (%)
timeFrame: (days 0 and 4)
measure: Change in lean mass (kg)
timeFrame: (days 0 and 4)
measure: Change in waist circumference
timeFrame: (days 0 and 4)
measure: Change in hip circumference
timeFrame: (days 0 and 4)
measure: Changes in waist to hip ratio
timeFrame: (days 0 and 4)
measure: Change in resting metabolic rate
timeFrame: (days 0 and 4)
measure: Change in substrate utilization
timeFrame: (days 0 and 4)
measure: Change peripheral blood pressure
timeFrame: (days 0 and 4)
measure: Change in central blood pressure
timeFrame: (days 0 and 4)
measure: Change in augmentation index
timeFrame: (days 0 and 4)
measure: Change in heart rate variability
timeFrame: (days 0 and 4)
measure: Changes in blood lipid profile
timeFrame: (days 0 and 4)
measure: Changes in blood glucose regulation
timeFrame: (days 0 and 4)
measure: Changes in blood markers of inflammation
timeFrame: (days 0 and 4)
measure: Changes in circulating regulators of metabolism
timeFrame: (days 0 and 4)
measure: Changes in perceptual indicators
timeFrame: Days 0 through 4
measure: Changes in sleep health
timeFrame: Days 0 through 4
Other outcomes:
Locations:
city: Saratoga Springs
country: United States
facility: Skidmore College
state: New York
Study officials:
affiliation: Skidmore College
name: Stephen Ives, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: