An interventional study of 3 day caloric restriction/metabolic reset in Obesity, Overweight and Intermittent Fasting, sponsored by Skidmore College. Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-13.
Sponsored by Skidmore College · Not applicable, Interventional, and Basic science
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 15 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Skidmore College is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm pre-post dietary intervention (caloric restriction)
Dietary Supplement: 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.
Change in body weight
Change in total body weight
Time frame: (days 0 and 4)
Change in total body water
Assessed via bioelectric impedance analysis (BIA)
Time frame: (days 0 and 4)
Change in body fat (%)
Assessed via bioelectric impedance analysis (BIA)
Time frame: (days 0 and 4)
Change in lean mass (kg)
Assessed via bioelectric impedance analysis (BIA)
Time frame: (days 0 and 4)
Change in waist circumference
Changes in waist circumference (cm) using Gulick tape measure
Time frame: (days 0 and 4)
Change in hip circumference
Changes in hip circumference (cm) using Gulick tape measure
Time frame: (days 0 and 4)
Changes in waist to hip ratio
Changes in waist:hip ratio derived from waist and hip circumferences
Time frame: (days 0 and 4)
Change in resting metabolic rate
Change in resting metabolic rate assessed using the ventilated hood technique and indirect calorimetry (TrueOne2400, Parvomedics).
Time frame: (days 0 and 4)
Change in substrate utilization
Change in resting-fasted substrate utilization (Fat vs. Carbohydrate) using the ventilated hood technique and indirect calorimetry (TrueOne2400, Parvomedics).
Time frame: (days 0 and 4)
Change peripheral blood pressure
Changes in peripheral blood pressure assessed using oscillometric cuff technique on the brachial artery (Sphygmocor Xcel).
Time frame: (days 0 and 4)
Change in central blood pressure
Change in estimated central blood pressure, assessed using oscillometric cuff technique and generalized transfer function (Sphygmocor Xcel).
Time frame: (days 0 and 4)
Change in augmentation index
Changes in augmentation index (a marker of vascular stiffness) will be assessed using oscillometric cuff technique and generalized transfer function (Sphygmocor Xcel).
Time frame: (days 0 and 4)
Change in heart rate variability
Changes in time-domain based heart rate variability will be assessed using standard ECG with subsequent automated analysis with artifact correction (H7 PolarUSA and Elite HRV).
Time frame: (days 0 and 4)
Changes in blood lipid profile
Changes in blood lipids (total Cholesterol, TC; low density lipoprotein LDL Cholesterol; high density lipoprotein, HDL Cholesterol; and TC:HDL ratio) will be assessed using standard techniques (Cholestech System)
Time frame: (days 0 and 4)
Changes in blood glucose regulation
Changes in fasting blood glucose and insulin using standard techniques.
Time frame: (days 0 and 4)
Changes in blood markers of inflammation
Changes in blood inflammatory markers (Tumor Necrosis Factor alpha (TNFa) and Cortisol) using standard techniques.
Time frame: (days 0 and 4)
Changes in circulating regulators of metabolism
Changes in blood levels of the metabolically active hormones (thyroid stimulating hormone (TSH), protein yy (PYY), neuropeptide y (NPY), Ghrelin, and Leptin) using standard biochemical techniques.
Time frame: (days 0 and 4)
Changes in perceptual indicators
Changes in self-reported sensations of hunger, fullness, satiety, and gastrointestinal discomfort will be assessed using visual analog scales (VAS). The VAS is 100 mm line ranging from 0 to 100, where a participant who marks 0 indicates "none" (not hungry at all or no gastrointestinal distress) vs. marking at 100 would indicate the maximal response ("severely hungry" or "severe gastrointestinal distress"). The hunger, fullness, and satiety ratings are not necessarily worse or better type outcomes, but simply descriptive. The magnitude is quantified by measuring the distance the participant marks on the 100mm line. In the case of gastrointestinal distress, scores over 51, or large increases in GID would be considered a less favorable outcome and the higher the score the worse the outcome on this specific item.
Time frame: Days 0 through 4
Changes in sleep health
Changes in sleep quantity and quality will be assessed using the consensus sleep diary, core form. This form records times for going to sleep, falling asleep, waking during the night, waking in the morning. There is only one likert type item which ask participants to subjectively rate the quality of sleep from very poor to very good, and reports of poor or very poor sleep would be considered worse outcomes, particularly those with changes in response to the dietary outcome.
Time frame: Days 0 through 4
Plan to share: No — Requests for data may be reviewed on a case-by-case basis, after publication of initial findings.
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Sep 2022, 3 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 3 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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