ObesityNCT05422391
The Acute Effects of Caloric Restriction on Anthropometrics, Metabolism, and Cardiovascular Health in Overweight Adults
A study testing 3 day caloric restriction/metabolic reset in people with Obesity and Overweight, run by Skidmore College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Intermittent Fasting
- What is being tested?
- 3 day caloric restriction/metabolic reset
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 17 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- 3 day caloric restriction/metabolic reset
- Keywords
- intermittent fasting, caloric restriction
- Medical subject headings
- Obesity, Overweight, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 day caloric restriction/metabolic resetDietary supplement
Participants will consume ~500 kcal/day, using commercially available products (Plexus(r)), for 3 days, measuring physiological relevant parameters pre-and post-intervention.
| Study group | Role | What they receive |
|---|---|---|
| Pre- post-dietary intervention | Other | Single arm pre-post dietary intervention (caloric restriction) Receives: Dietary Supplement: 3 day caloric restriction/metabolic reset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Change in total body weight
Measured: (days 0 and 4)
Secondary outcomes (18)
Change in total body water
Assessed via bioelectric impedance analysis (BIA)
Measured: (days 0 and 4)
Change in body fat (%)
Assessed via bioelectric impedance analysis (BIA)
Measured: (days 0 and 4)
Change in lean mass (kg)
Assessed via bioelectric impedance analysis (BIA)
Measured: (days 0 and 4)
Change in waist circumference
Changes in waist circumference (cm) using Gulick tape measure
Measured: (days 0 and 4)
Change in hip circumference
Changes in hip circumference (cm) using Gulick tape measure
Measured: (days 0 and 4)
Changes in waist to hip ratio
Changes in waist:hip ratio derived from waist and hip circumferences
Measured: (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).
Measured: (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).
Measured: (days 0 and 4)
Change peripheral blood pressure
Changes in peripheral blood pressure assessed using oscillometric cuff technique on the brachial artery (Sphygmocor Xcel).
Measured: (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).
Measured: (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).
Measured: (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).
Measured: (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)
Measured: (days 0 and 4)
Changes in blood glucose regulation
Changes in fasting blood glucose and insulin using standard techniques.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: 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.
Measured: Days 0 through 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start7 Jun 2022
- Primary completion7 Sep 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will utilize a pre-post interventional design to assess the acute effects of a 3 day caloric restriction protocol.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skidmore College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen J. Ives, Skidmore College
- Investigators
- Stephen Ives, Ph.D., Principal investigator, Skidmore College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422391
- Sponsor's protocol ID
- 2204-1028
- Status last verified
- Dec 2022
- First submitted
- 17 May 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests for data may be reviewed on a case-by-case basis, after publication of initial findings.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05422391
- Acronym / sponsor ID
- 2204-1028
- Conditions
- Obesity, Overweight, Intermittent Fasting
- Keywords
- intermittent fasting, caloric restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Skidmore CollegeUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will utilize a pre-post interventional design to assess the acute effects of a 3 day caloric restriction protocol.
| Arm | Type | Receives |
|---|---|---|
| Pre- post-dietary intervention | Other | Dietary Supplement: 3 day caloric restriction/metabolic resetSingle arm pre-post dietary intervention (caloric restriction) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 day caloric restriction/metabolic resetParticipants will consume ~500 kcal/day, using commercially available products (Plexus(r)), for 3 days, measuring physiological relevant parameters pre-and post-intervention. | Dietary supplement | Pre- post-dietary intervention |
Primary outcome
Change in body weight
Time frame: (days 0 and 4)
Change in total body weight
18 secondary outcomes
Change in total body water
Time frame: (days 0 and 4)
Change in body fat (%)
Time frame: (days 0 and 4)
Change in lean mass (kg)
Time frame: (days 0 and 4)
Change in waist circumference
Time frame: (days 0 and 4)
Change in hip circumference
Time frame: (days 0 and 4)
Changes in waist to hip ratio
Time frame: (days 0 and 4)
Change in resting metabolic rate
Time frame: (days 0 and 4)
Change in substrate utilization
Time frame: (days 0 and 4)
Change peripheral blood pressure
Time frame: (days 0 and 4)
Change in central blood pressure
Time frame: (days 0 and 4)
Change in augmentation index
Time frame: (days 0 and 4)
Change in heart rate variability
Time frame: (days 0 and 4)
Changes in blood lipid profile
Time frame: (days 0 and 4)
Changes in blood glucose regulation
Time frame: (days 0 and 4)
Changes in blood markers of inflammation
Time frame: (days 0 and 4)
Changes in circulating regulators of metabolism
Time frame: (days 0 and 4)
Changes in perceptual indicators
Time frame: Days 0 through 4
Changes in sleep health
Time frame: Days 0 through 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: No. Requests for data may be reviewed on a case-by-case basis, after publication of initial findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Ives, Ph.D. principal investigator
Skidmore College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 day caloric restriction/metabolic reset in people with Obesity and Overweight, run by Skidmore College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: (days 0 and 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.