ObesityISOThriveNCT02501356
Effects of ISOThrive on Bodyweight, Body Composition, Hunger/Satiety and Cardiac Risk Measures in Overweight Adults
A study testing ISOThrive Supplement in people with Obesity, run by Griffin Hospital at 1 site in United States.
Trial summary
To compare the effects of daily intake of the ISOThrive supplement vs. a placebo on the primary outcome measure of body weight and secondary outcome measures (hunger/satiety, health-related measures and self-reported quality of life) in a group of overweight but otherwise healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- ISOThrive Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Nov 2015
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI of 25 and over and weight not > 350lb
- Age between 18 and 75
- Non-smokers
- Able to read and write in English
Who cannot join
- Pregnant and/or lactating women
- Evidence or history of substance or alcohol abuse (include if over 5years)
- History of major depression, bipolar disorder or schizophrenia, any type of obsessive-compulsive disorder
- Current history of migraine headaches (include if controlled with medication)
- Current use of any prescription or non-prescription weight loss products
- Tobacco use
Show all 19Show fewer
- Active eating disorder including anorexia nervosa and bulimia
- Known sensitivity or allergy to any of the ingredients in the product
- Symptomatic coronary artery disease or congestive heart failure
- History of a stroke in the past year
- Symptomatic arrhythmia
- Uncontrolled hypertension (i.e. systolic pressure >180 mmHg and or diastolic > 110 mmHg)
- History of a seizure in the past 5 years
- Any cancer in the past 5 years other than non-melanoma skin cancer or in-situ cervical cancer
- Active or history of inflammatory bowel disease
- Current use of TNF-alpha inhibitor medications
- Current use of COX-2 inhibitor medications
- Current use of JAK inhibitor medications
- History of weight loss procedures including bariatric surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-Griffin Prevention Research Center
Derby, Connecticut, 06418
About this study
To compare the effects of daily intake of the ISOThrive supplement vs. a placebo on the primary outcome measure of body weight and secondary outcome measures (hunger/satiety, health-related measures and self-reported quality of life) in a group of overweight but otherwise healthy adults.
Read the detailed description
Hypothesis
The investigator's hypothesize that daily intake for a 3-month period of the ISOThrive supplement vs. a placebo will demonstrate beneficial effects on the primary outcome measure of body weight and secondary outcome measures (hunger/satiety, health-related measures and self-reported quality of life) in a group of overweight adults.
Specific Aims
- To determine the effects of the ISOThrive supplement on body weight in overweight adults encouraged to reduce calories and exercise regularly, but on an unrestricted diet and without specific exercise instruction. Specifically, to demonstrate a clinically meaningful reduction in body weight in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement.
- To determine the effects of the ISOThrive supplement on hunger/satiety, body composition, waist circumference, blood pressure, blood glucose levels, blood lipid levels, inflammatory and satiety serum markers and self-reported quality of life in overweight adults encouraged to reduce calories and exercise regularly, but on an unrestricted diet and without specific exercise instruction. Specifically, to demonstrate an improvement in hunger/satiety and a clinically meaningful improvement in other measures in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement.
- To demonstrate the safety of the ISOThrive supplement in terms of its impact on blood, liver and kidney function in overweight adults. Specifically, to demonstrate the lack of a negative impact on blood, liver and kidney function tests in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement.
- To determine the effects of the ISOThrive supplement on Gut health. Specifically, to demonstrate improvement in Gut health as measured by abdominal bloating, abdominal gas, and abdominal pain/discomfort at the end of 3 months of daily consumption of the ISOThrive supplement.
- Conditions
- Obesity
- Being tested
- ISOThrive Supplement, Placebo Supplement
- Keywords
- prebiotic, dietary supplement
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISOThrive SupplementDietary supplement
Consumption of ISOThrive supplements for 3 months
Placebo SupplementDietary supplement
Consumption of Placebo supplement (Magnesium stearate or methylcellulose) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| ISOThrive supplement 1 | Active comparator | Participants assigned to the ISOThrive supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period. Receives: Dietary Supplement: ISOThrive Supplement |
| ISOThrive supplement 2 | Active comparator | Participants assigned to the ISOThrive supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period. Receives: Dietary Supplement: ISOThrive Supplement |
| Placebo supplement | Placebo comparator | Participants assigned to the placebo supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period. Receives: Dietary Supplement: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body weight will be measured at the beginning and at the end of the study using a calibrated digital scale.
Measured: Up to 12 weeks
Secondary outcomes (19)
Hunger/satiety
will be assessed at the beginning and at the end of the study using a Visual Analog Scale (VAS) that will ask participants a series of questions to be completed at 2 time points: mid-morning between breakfast and lunch, and late evening between dinner and bed time. The VAS questions require participants to rate on a scale the strength of specific sensations they are feeling (i.e., hunger, thirst, amount of food they could eat "right now", nausea, and fullness) by placing a vertical mark on the scale in response to each question.
Measured: Up to 12 weeks
Satiety indicators
will be assessed at the beginning and end of the study with biological markers using Glucagon-like peptide-1 (GLP-1), PYY and ghrelin.
Measured: Up to 12 weeks
Dietary intake data
Dietary intake will be assessed at the beginning and at the end of the study. Each participant will complete three 24-hour dietary recalls (two for weekdays, and one for a weekend day) using an online Automated Self-Administered 24-Hour Recall (ASA24) (available from the National Cancer Institute at http://riskfactor.cancer.gov/tools/instruments/asa24/). This data will be used to provide a representational measure of intake of kilocalories and macronutrients (protein, fat, and carbohydrates).
Measured: Up to 12 weeks
Body mass index (BMI)
will be measured at the beginning and at the end of the study . BMI will be calculated as weight (kg) divided by height in meters (m) squared. Height will be measured by using a calibrated stadiometer.
Measured: Up to 12 weeks
Body composition
will be measured using bioelectrical impedance analysis, which uses the resistance of electrical flow through the body to estimate body fat. The Tanita SC-240 Body Composition Analyzer will be used to measure body composition. The SC-240 Body Composition Analyzer measures weight and calculates body fat percentage and total body water percentage in addition to BMI. Measures will be taken at baseline, 6 weeks and at the end of the 3-month intervention period.
Measured: Up to 12 weeks
Leptin
Leptin levels will be used as a biomarker to monitor the amount of body fat. Leptin level will be assessed at the beginning and at the end of the study . Leptin is a hormone secreted exclusively by adipose cells in response to an increase in body fat mass, and is an important component in the regulation of long-term hunger and food intake. Leptin serves as the brain's indicator of the body's total energy stores. When leptin levels rise in the bloodstream they bind to receptors in arcuate nucleus (ARC). Leptin suppress the release of neuropeptide Y (NPY), which in turn prevents the release of appetite enhancing hypocretin (orexins) from the lateral hypothalamus. This decreases appetite and food intake, promoting weight loss. It also stimulates the expression of cocaine- and amphetamine-regulated transcript (CART).
Measured: Up to 12 weeks
Waist circumference
will be measured at the beginning and end of the study using guidelines of the National Obesity Expert Panel Report.
Measured: Up to 12 weeks
Blood pressure
will be measured by using a Dinamap Monitor Pro 100 (GE Healthcare, Piscataway, NJ) after sitting for 5 minutes. Both systolic and diastolic pressures will be calculated as the mean value of 2 readings 5 minutes apart for each participant at every time point of assessment. Blood pressure will be assessed at baseline, 6 weeks, and at the end of 3 months
Measured: Up to 12 weeks
Homeostasis model assessment of insulin resistance (HOMA-IR)
will be measured in a fasting state at baseline and 12 weeks. Homeostasis model assessment of insulin resistance (HOMA-IR) values will be calculated from fasting serum glucose and serum insulin levels to gauge the degree of insulin resistance.
Measured: 12 weeks
Blood Lipid levels
Total cholesterol (Tchol), triglycerides (TRIG), and high-density lipoprotein (HDL) will be obtained by direct measurements. Very-low-density lipoprotein (VLDL) and low-density-lipoprotein (LDL) are obtained by calculation: VLDL = TRIG/5; and LDL = Tchol - (VLDL + HDL). The HDL:Tchol ratio will be used to evaluate the impact of the supplement on lipid panel. The lipid profile will be assessed at baseline and at the end of 3 months.
Measured: Up to 12 weeks
Abdominal symptoms
We will assess abdominal bloating, abdominal gas, and abdominal pain/discomfort at 6 weeks and at the end of 3 months. Abdominal symptoms will be assessed using a side effects survey.
Measured: 12 weeks
Change in Quality of life
will be assessed using the SF-12 (http://www.sf-36.org/tools/sf12.shtml). The SF-12v2 Health Survey uses 12 questions to assess 8 domains of health and well-being (general health, physical function, physical role, bodily pain, mental health, emotional role, vitality, and social function) within the past 4 weeks. The SF-12v2 is a practical, reliable, and valid measure of physical and mental health and takes only 2 to 3 minutes to complete. This tool will be administered at baseline and at the end of 3 months.
Measured: Up to 12 weeks
Liver function
will be assessed at baseline and at the end of 3 months via a comprehensive metabolic panel to explore the safety of the ISOThrive supplement. Liver function will be evaluated based on levels of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, and bilirubin.
Measured: Up to 12 weeks
Kidney function
Kidney function will be evaluated using blood urea nitrogen and creatinine.
Measured: Up to 12 weeks
Urine
Urine samples will be collected from participants at baseline and at the end of 3 months. Urinalysis will be used to detect substances or cellular material in the urine associated with different metabolic and kidney disorders.
Measured: Up to 12 weeks
Complete blood count
will be performed to assess the different components of blood.
Measured: Up to 12 weeks
Stool
The stool analysis will be done with samples taken for a subset of 40 subjects. DNA extraction (i.e. purification of DNA from sample), LH-PCR Fingerprinting (i.e to amplify a single copy or a few copies of a piece of DNA across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence), and Multitag Pyrosequencing (i.e. determining the order of nucleotides in DNA based on the "sequencing by synthesis" principle) will be done with the collected stool at one week before the start of the intervention (i.e. one week before taking product), the day before the start of the intervention, and at the end of 3 months.
Measured: Up to 12 weeks
Inflammatory biomarkers
High sensitivity C-reactive protein, TNF, IL6, IL10 and Interferon gamma will be used to monitor inflammation in our study participants. These biomarkers will be assessed at baseline and at the end of 3 months.
Measured: Up to 12 weeks
Physical activity
Physical activity will be assessed at baseline and at the end of 3 months. PA will be assessed by the International Physical Activity Questionnaire (IPAQ).31 The IPAQ is a valid and reliable tool to assess physical activity in adults. It is a more comprehensive tool containing information on weekly activities in household and yard-work activities, occupational activity, transport, leisure time physical activity and sedentary behavior.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Griffin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ISOThrive Inc.
- Responsible party
- Sponsor
- Investigators
- David L. Katz, MD, MPH, Principal investigator, Yale-Griffin Prevention Research CenterValentine Y. Njike, MD,MPH, Principal investigator, Yale-Griffin Prevention Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501356
- Sponsor's protocol ID
- 2014-09
- Acronym
- ISOThrive
- Status last verified
- Mar 2020
- First submitted
- 22 Apr 2015
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ISOThrive on Bodyweight, Body Composition, Hunger/Satiety and Cardiac Risk Measures in Overweight Adults
- ClinicalTrials.gov ID
- NCT02501356
- Acronym / sponsor ID
- ISOThrive / 2014-09
- Conditions
- Obesity
- Keywords
- prebiotic, dietary supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Collaborators
- ISOThrive Inc.
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Jul 2015 (estimated)
- 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.
To compare the effects of daily intake of the ISOThrive supplement vs. a placebo on the primary outcome measure of body weight and secondary outcome measures (hunger/satiety, health-related measures and self-reported quality of life) in a group of overweight but otherwise healthy adults.
Detailed description
Hypothesis
The investigator's hypothesize that daily intake for a 3-month period of the ISOThrive supplement vs. a placebo will demonstrate beneficial effects on the primary outcome measure of body weight and secondary outcome measures (hunger/satiety, health-related measures and self-reported quality of life) in a group of overweight adults.
Specific Aims
- To determine the effects of the ISOThrive supplement on body weight in overweight adults encouraged to reduce calories and exercise regularly, but on an unrestricted diet and without specific exercise instruction. Specifically, to demonstrate a clinically meaningful reduction in body weight in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement.
- To determine the effects of the ISOThrive supplement on hunger/satiety, body composition, waist circumference, blood pressure, blood glucose levels, blood lipid levels, inflammatory and satiety serum markers and self-reported quality of life in overweight adults encouraged to reduce calories and exercise regularly, but on an unrestricted diet and without specific exercise instruction. Specifically, to demonstrate an improvement in hunger/satiety and a clinically meaningful improvement in other measures in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement.
- To demonstrate the safety of the ISOThrive supplement in terms of its impact on blood, liver and kidney function in overweight adults. Specifically, to demonstrate the lack of a negative impact on blood, liver and kidney function tests in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement.
- To determine the effects of the ISOThrive supplement on Gut health. Specifically, to demonstrate improvement in Gut health as measured by abdominal bloating, abdominal gas, and abdominal pain/discomfort at the end of 3 months of daily consumption of the ISOThrive supplement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ISOThrive supplement 1 | Active comparator | Dietary Supplement: ISOThrive SupplementParticipants assigned to the ISOThrive supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period. |
| ISOThrive supplement 2 | Active comparator | Dietary Supplement: ISOThrive SupplementParticipants assigned to the ISOThrive supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period. |
| Placebo supplement | Placebo comparator | Dietary Supplement: Placebo SupplementParticipants assigned to the placebo supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI of 25 and over and weight not > 350lb
- Age between 18 and 75
- Non-smokers
- Able to read and write in English
Key exclusion criteria (19 listed)
- Pregnant and/or lactating women
- Evidence or history of substance or alcohol abuse (include if over 5years)
- History of major depression, bipolar disorder or schizophrenia, any type of obsessive-compulsive disorder
- Current history of migraine headaches (include if controlled with medication)
- Current use of any prescription or non-prescription weight loss products
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 |
|---|---|---|
| ISOThrive SupplementConsumption of ISOThrive supplements for 3 months | Dietary supplement | ISOThrive supplement 1, ISOThrive supplement 2 |
| Placebo SupplementConsumption of Placebo supplement (Magnesium stearate or methylcellulose) for 3 months | Dietary supplement | Placebo supplement |
Primary outcome
Body Weight
Time frame: Up to 12 weeks
Body weight will be measured at the beginning and at the end of the study using a calibrated digital scale.
19 secondary outcomes
Hunger/satiety
Time frame: Up to 12 weeks
Satiety indicators
Time frame: Up to 12 weeks
Dietary intake data
Time frame: Up to 12 weeks
Body mass index (BMI)
Time frame: Up to 12 weeks
Body composition
Time frame: Up to 12 weeks
Leptin
Time frame: Up to 12 weeks
Waist circumference
Time frame: Up to 12 weeks
Blood pressure
Time frame: Up to 12 weeks
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: 12 weeks
Blood Lipid levels
Time frame: Up to 12 weeks
Abdominal symptoms
Time frame: 12 weeks
Change in Quality of life
Time frame: Up to 12 weeks
Liver function
Time frame: Up to 12 weeks
Kidney function
Time frame: Up to 12 weeks
Urine
Time frame: Up to 12 weeks
Complete blood count
Time frame: Up to 12 weeks
Stool
Time frame: Up to 12 weeks
Inflammatory biomarkers
Time frame: Up to 12 weeks
Physical activity
Time frame: Up to 12 weeks
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 26 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
David L. Katz, MD, MPH principal investigator
Yale-Griffin Prevention Research Center
Valentine Y. Njike, MD,MPH principal investigator
Yale-Griffin Prevention Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISOThrive Supplement in people with Obesity, run by Griffin Hospital 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 4 inclusion and 19 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 26 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Body Weight (time frame: Up to 12 weeks). 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 26 Mar 2020.