Body WeightNCT04107155
Study to Evaluate the Effects of a Weight Management Program on Body Weight
A study testing Weight Management Formulation and Handout with Suggestions for Healthy Eating and Overall Health in people with Body Weight, run by Supplement Formulators, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to assess the safety and effectiveness of the Weight Management Program on body weight Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- What is being tested?
- Weight Management Formulation and Handout with Suggestions for Healthy Eating and Overall Health
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2019to 20 Dec 2019
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ambulatory, male or female, 21 - 70 years of age (volunteers between the ages of 71 and 75 inclusive will be permitted on a case-by-case basis at the discretion of the principal investigator).
- A body mass index (BMI) of 25-34.9
- Generally healthy and having no significant difficulty with digestion or absorption of food
- Has been generally weight stable for the past six months (±6 lbs.)
- Willing and able to give written informed consent
- Clearly understands the procedures and study requirements
Show all 9Show fewer
- Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
- Able to communicate, including reading, in English
- Have not taken any nutritional supplements that may contain any of the components of the study product for a minimum of 14 days prior to baseline screening
Who cannot join
- Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug or any product containing cannabidiol (CBD) or tetrahydrocannabinol (THC) in the past 30 days
- Donation of blood within 30 days prior to screening/baseline
- Inability to provide a venous blood sample
- Participation in another study within 30 days prior to baseline/screening
- Being pregnant or planning on becoming pregnant during study participation; or breast feeding
- History of allergy or sensitivity to any component of the study products including saffron, dicalcium phosphate, gynostemma extract, hesperidin, microcrystalline cellulose, stearic acid, croscarmellose sodium, hydroxypropyl cellulose, vegetable cellulose, hypromellose, glycerin, silica, silicon dioxide, vegetable stearate, magnesium stearate or acacia gum
Show all 34Show fewer
- Currently taking a medication or dietary supplement specifically for weight loss and unwilling to washout (i.e. stop taking) for 14 days prior to baseline
- Currently participating in a weight loss program and unwilling to discontinue participation prior to baseline
- Having been diagnosed, received medical treatment or taking medication daily for the following medical condition(s):
- Eating disorder (including anorexia nervosa, bulimia nervosa, binge eating disorder or avoidant or restrictive food intake disorder)
- Psychiatric disorder
- Presence of active or recurring clinically significant conditions as follows:
- Diabetes mellitus or other endocrine disease
- Eating disorder
- Acute or chronic inflammatory disease or autoimmune disease
- Cardiovascular disease including heart and blood vessel disease, arrhythmia, heart attack, stroke or heart valve problem
- Gastrointestinal disease including gallbladder problems, gallstones or biliary tract obstruction
- Thyroid disease (unless on a stable dose of medication for 3 months prior to screening and unlikely to change medication or dose during the study)
- Hypertension (unless on a stable dose of medication for 3 months prior to screening and unlikely to change medication or dose during the study)
- Neurologic condition/disease
- Cancer (unless skin cancer other than melanoma which has been treated > 3 years prior to Baseline/screening)
- Liver, pancreatic or kidney disease
- Pulmonary disease
- Blood coagulation disorder or other hematologic disease
- Other condition or medication use that would preclude participation in the study in the judgment of the investigator/sub-investigator (Sub-I)
- Currently taking any medications or treatment for a psychiatric disorder (bipolar disorder, manic disorder, schizophrenia, apathetic (inherited) disorder), that include antidepressant drugs, including the selective serotonin reuptake inhibitors (SSRIS), tricyclic and atypical antidepressants; benzodiazepines; central nervous system (CNS) depressants, dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs); pentazocine, phenothiazines and tramadol. These may preclude participation in the study dependent on the judgment of the investigator/sub investigator.
- Currently taking or having taken within the 30 days prior to screening/baseline any hormone replacement therapy (including dehydroepiandrosterone (DHEA), estrogen, progesterone, or testosterone; except those utilized as a method of birth control and which have been taken for > 3 months, with no anticipated change for the duration of the study)
- Having had a surgical procedure or having an internal medical device which, in the judgment of the PI/Sub-I, would preclude participation in the study
- Having abnormal screening laboratory test values including bilirubin > 2.5 x upper limit of normal (ULN), aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 x ULN, serum creatinine > 1.5 mg/dL, blood glucose < 85 mg/dL or > 110 mg/dL, thyroid- stimulating hormone (TSH) level < 0.450 or > 4.500 milliunits per liter (mU/L) or other lab test result(s) that would preclude study participation in the judgement of the PI/Sub-I
- Having blood pressure readings at Baseline/screening > 140 systolic or > 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the PI/Sub-I
- Currently consumes more than 7 standard alcoholic drinks per week for women and 14 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
- Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos
- History of known or suspected substance abuse (e.g. alcohol, opiates, benzodiazepines or amphetamines).
- Having any other circumstance that precludes study participation in the judgment of the PI/Sub-I, including use of other nutritional supplements, which will be evaluated on a case-by-case basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, 33308
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Weight Management Program on Body Weight in Individuals Who Are Overweight and Otherwise Healthy
The purpose of the study is to assess the safety and effectiveness of the Weight Management Program on body weight
Read the detailed description
This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a Weight Management program on body weight. Each subject will receive a specific dose of the study product (A) to be taken twice daily with breakfast and dinner and a specific dose of the study product (B) to be taken 15 minutes before lunch daily for a total of 60 days. Each subject based upon the randomization will also receive a handout with suggestions for healthy eating and overall health.
Participants receive questionnaires, assessments, blood tests, vital signs and a body composition analysis.
The primary objective is the assessment of the change in body weight in response to the Weight Management program relative to baseline compared with placebo
The secondary objective is the assessment of the change in waist circumference, parameters from the body composition analysis, appetite, the levels of blood lipids and C-reactive protein in response to the Weight Management program relative to baseline compared with placebo
- Conditions
- Body Weight
- Being tested
- Weight Management Formulation, Placebo, Handout with Suggestions for Healthy Eating and Overall Health
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Management FormulationDietary supplement
Saffron extract and Gynostemma extract with hesperidin
PlaceboDietary supplement
Placebo
Handout with Suggestions for Healthy Eating and Overall HealthOther
Suggestions for Healthy Eating and Overall Health
Handout with Suggestions for Healthy Eating and Overall HealthOther
Suggestions for Healthy Eating and Overall Health
| Study group | Role | What they receive |
|---|---|---|
| Weight Management Program | Experimental | Dietary Supplement: Saffron extract and Gynostemma extract with hesperidin and a handout with suggestions for healthy eating and overall health Receives: Dietary Supplement: Weight Management Formulation; Other: Handout with Suggestions for Healthy Eating and Overall Health |
| Placebo | Placebo comparator | Placebo and handout with suggestions for healthy eating and overall health Receives: Dietary Supplement: Placebo; Other: Handout with Suggestions for Healthy Eating and Overall Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the mean change in Body Weight from baseline
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
Measured: 60 days
Secondary outcomes (17)
Assessment of the mean change in Waist Circumference from baseline
Mean change from baseline to Day 60 in inches
Measured: 60 days
Assessment of the mean change in Appetite from baseline
Mean change in the scores on a simplified nutritional appetite questionnaire from baseline. to Day 60. A numerical scale of 1-5 is used with the sum of the individual items totaling the score. A sum of less than or equal to 14 represents an improved score in support of weight loss.
Measured: 60 days
Assessment of the mean change in the Total Cholesterol level from baseline
Mean change from baseline to Day 60 in mg/dL
Measured: 60 days
Assessment of the mean change in the Triglyceride level from baseline
Mean change from baseline to Day 60 in mg/dL
Measured: 60 days
Assessment of the mean change in the HDL Cholesterol level from baseline
Mean change from baseline to Day 60 in mg/dL
Measured: 60 days
Assessment of the mean change in the LDL Cholesterol level from baseline
Mean change from baseline to Day 60 in mg/dL
Measured: 60 days
Assessment of the mean change in the Total Cholesterol/HDL ratio from baseline
Mean change from baseline to Day 60 in ratio units
Measured: 60 days
Assessment of the mean change in the Total Body Water from baseline
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
Measured: 60 days
Assessment of the mean change in the Lean Body Mass from baseline
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
Measured: 60 days
Assessment of the mean change in the Skeletal Muscle Mass from baseline
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
Measured: 60 days
Assessment of the mean change in the Body Fat Mass from baseline
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
Measured: 60 days
Assessment of the mean change in the Extracellular Water (ECW)/Total Body Water (TBW) ratio from baseline
Mean change from baseline to Day 60 in ratio units from the Body Composition Analyzer
Measured: 60 days
Assessment of the mean change in the Basal Metabolic Rate from baseline
Mean change from baseline to Day 60 in kcal from the Body Composition Analyzer
Measured: 60 days
Assessment of the mean change in the Visceral Fat Level from baseline
Mean change from baseline to Day 60 in the level from the Body Composition Analyzer
Measured: 60 days
Assessment of the mean change in the Body Mass Index (BMI) from baseline
Mean change from baseline to Day 60 in (weight)kg/(height) m^2 from the Body Composition Analyzer
Measured: 60 days
Assessment of the mean change in the Percent Body Fat from baseline
Mean change from baseline to Day 60 in the percent from the Body Composition Analyzer
Measured: 60 days
Assessment of the mean change in the hs (high sensitivity)-C-reactive protein level from baseline
Mean change from baseline to Day 60 in mg/L
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start23 Jul 2019
- Primary completion29 Nov 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supplement Formulators, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Swick, Ph.D, Principal investigator, LIfe Extension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107155
- Sponsor's protocol ID
- CL100
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aranganathan S, Nalini N. Efficacy of the potential chemopreventive agent, hesperetin (citrus flavanone), on 1,2-dimethylhydrazine induced colon carcinogenesis. Food Chem Toxicol. 2009 Oct;47(10):2594-600. doi: 10.1016/j.fct.2009.07.019. Epub 2009 Jul 24.
PubMed 19632289Carling D, Sanders MJ, Woods A. The regulation of AMP-activated protein kinase by upstream kinases. Int J Obes (Lond). 2008 Sep;32 Suppl 4:S55-9. doi: 10.1038/ijo.2008.124.
PubMed 18719600Chiranthanut N, Teekachunhatean S, Panthong A, Khonsung P, Kanjanapothi D, Lertprasertsuk N. Toxicity evaluation of standardized extract of Gynostemma pentaphyllum Makino. J Ethnopharmacol. 2013 Aug 26;149(1):228-34. doi: 10.1016/j.jep.2013.06.027. Epub 2013 Jun 21.
PubMed 23796877Dallal, G. (2017, July 10). www.Randomization.com. Retrieved from Randomization.com: http://www.randomization.com
Ding, Y., Tang, K., Li, F., & et al. (2010). Effects of Gypenosides from Gynostemma pentaphyllum supplementation on exercise-induced fatigue in mice. African Journal of Agricultural Research, 5(6), 707-711.
Diseases, N. I. (n.d.). www.niddk.nih.gov/health-information/weight-management. Retrieved May 6, 2019, from Weight Management: https://www.niddk.nih.gov/health-information/weight-management
El-Marasy SA, Abdallah HM, El-Shenawy SM, El-Khatib AS, El-Shabrawy OA, Kenawy SA. Anti-depressant effect of hesperidin in diabetic rats. Can J Physiol Pharmacol. 2014 Nov;92(11):945-52. doi: 10.1139/cjpp-2014-0281. Epub 2014 Sep 19.
PubMed 25358020Food and Drug Administration. (2005, March 11). Guidance for Industry on Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Federal Register, 70(140), 1-27. Retrieved from trc.
Garg A, Garg S, Zaneveld LJ, Singla AK. Chemistry and pharmacology of the Citrus bioflavonoid hesperidin. Phytother Res. 2001 Dec;15(8):655-69. doi: 10.1002/ptr.1074.
PubMed 11746857Gauhar R, Hwang SL, Jeong SS, Kim JE, Song H, Park DC, Song KS, Kim TY, Oh WK, Huh TL. Heat-processed Gynostemma pentaphyllum extract improves obesity in ob/ob mice by activating AMP-activated protein kinase. Biotechnol Lett. 2012 Sep;34(9):1607-16. doi: 10.1007/s10529-012-0944-1. Epub 2012 May 11.
PubMed 22576281Ghasemi T, Abnous K, Vahdati F, Mehri S, Razavi BM, Hosseinzadeh H. Antidepressant Effect of Crocus sativus Aqueous Extract and its Effect on CREB, BDNF, and VGF Transcript and Protein Levels in Rat Hippocampus. Drug Res (Stuttg). 2015 Jul;65(7):337-43. doi: 10.1055/s-0034-1371876. Epub 2014 Apr 2.
PubMed 24696423Gout B, Bourges C, Paineau-Dubreuil S. Satiereal, a Crocus sativus L extract, reduces snacking and increases satiety in a randomized placebo-controlled study of mildly overweight, healthy women. Nutr Res. 2010 May;30(5):305-13. doi: 10.1016/j.nutres.2010.04.008.
PubMed 20579522Gynostemma Extract. (2015). Retrieved from UENSUN: http://naturalplantextract.com/herbal-extract/gynostemma-extract.html
Hardie DG. AMP-activated protein kinase: a key system mediating metabolic responses to exercise. Med Sci Sports Exerc. 2004 Jan;36(1):28-34. doi: 10.1249/01.MSS.0000106171.38299.64.
PubMed 14707764Hardie DG. AMPK: a key regulator of energy balance in the single cell and the whole organism. Int J Obes (Lond). 2008 Sep;32 Suppl 4:S7-12. doi: 10.1038/ijo.2008.116.
PubMed 18719601
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Weight Management Program on Body Weight in Individuals Who Are Overweight and Otherwise Healthy
- ClinicalTrials.gov ID
- NCT04107155
- Acronym / sponsor ID
- CL100
- Conditions
- Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Supplement Formulators, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 27 Sep 2019 (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 the study is to assess the safety and effectiveness of the Weight Management Program on body weight
Detailed description
This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a Weight Management program on body weight. Each subject will receive a specific dose of the study product (A) to be taken twice daily with breakfast and dinner and a specific dose of the study product (B) to be taken 15 minutes before lunch daily for a total of 60 days. Each subject based upon the randomization will also receive a handout with suggestions for healthy eating and overall health.
Participants receive questionnaires, assessments, blood tests, vital signs and a body composition analysis.
The primary objective is the assessment of the change in body weight in response to the Weight Management program relative to baseline compared with placebo
The secondary objective is the assessment of the change in waist circumference, parameters from the body composition analysis, appetite, the levels of blood lipids and C-reactive protein in response to the Weight Management program relative to baseline compared with placebo
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Management Program | Experimental | Dietary Supplement: Weight Management Formulation, Other: Handout with Suggestions for Healthy Eating and Overall HealthDietary Supplement: Saffron extract and Gynostemma extract with hesperidin and a handout with suggestions for healthy eating and overall health |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Other: Handout with Suggestions for Healthy Eating and Overall HealthPlacebo and handout with suggestions for healthy eating and overall health |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ambulatory, male or female, 21 - 70 years of age (volunteers between the ages of 71 and 75 inclusive will be permitted on a case-by-case basis at the discretion of the principal investigator).
- A body mass index (BMI) of 25-34.9
- Generally healthy and having no significant difficulty with digestion or absorption of food
- Has been generally weight stable for the past six months (±6 lbs.)
- Willing and able to give written informed consent
Key exclusion criteria (34 listed)
- Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug or any product containing cannabidiol (CBD) or tetrahydrocannabinol (THC) in the past 30 days
- Donation of blood within 30 days prior to screening/baseline
- Inability to provide a venous blood sample
- Participation in another study within 30 days prior to baseline/screening
- Being pregnant or planning on becoming pregnant during study participation; or breast feeding
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 |
|---|---|---|
| Weight Management FormulationSaffron extract and Gynostemma extract with hesperidin | Dietary supplement | Weight Management Program |
| PlaceboPlacebo | Dietary supplement | Placebo |
| Handout with Suggestions for Healthy Eating and Overall HealthSuggestions for Healthy Eating and Overall Health | Other | Weight Management Program |
| Handout with Suggestions for Healthy Eating and Overall HealthSuggestions for Healthy Eating and Overall Health | Other | Placebo |
Primary outcome
Assessment of the mean change in Body Weight from baseline
Time frame: 60 days
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
17 secondary outcomes
Assessment of the mean change in Waist Circumference from baseline
Time frame: 60 days
Assessment of the mean change in Appetite from baseline
Time frame: 60 days
Assessment of the mean change in the Total Cholesterol level from baseline
Time frame: 60 days
Assessment of the mean change in the Triglyceride level from baseline
Time frame: 60 days
Assessment of the mean change in the HDL Cholesterol level from baseline
Time frame: 60 days
Assessment of the mean change in the LDL Cholesterol level from baseline
Time frame: 60 days
Assessment of the mean change in the Total Cholesterol/HDL ratio from baseline
Time frame: 60 days
Assessment of the mean change in the Total Body Water from baseline
Time frame: 60 days
Assessment of the mean change in the Lean Body Mass from baseline
Time frame: 60 days
Assessment of the mean change in the Skeletal Muscle Mass from baseline
Time frame: 60 days
Assessment of the mean change in the Body Fat Mass from baseline
Time frame: 60 days
Assessment of the mean change in the Extracellular Water (ECW)/Total Body Water (TBW) ratio from baseline
Time frame: 60 days
Assessment of the mean change in the Basal Metabolic Rate from baseline
Time frame: 60 days
Assessment of the mean change in the Visceral Fat Level from baseline
Time frame: 60 days
Assessment of the mean change in the Body Mass Index (BMI) from baseline
Time frame: 60 days
Assessment of the mean change in the Percent Body Fat from baseline
Time frame: 60 days
Assessment of the mean change in the hs (high sensitivity)-C-reactive protein level from baseline
Time frame: 60 days
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 17 Mar 2020.
- Background: PubMed 19632289Aranganathan S, Nalini N. Efficacy of the potential chemopreventive agent, hesperetin (citrus flavanone), on 1,2-dimethylhydrazine induced colon carcinogenesis. Food Chem Toxicol. 2009 Oct;47(10):2594-600. doi: 10.1016/j.fct.2009.07.019. Epub 2009 Jul 24.
- Background: PubMed 18719600Carling D, Sanders MJ, Woods A. The regulation of AMP-activated protein kinase by upstream kinases. Int J Obes (Lond). 2008 Sep;32 Suppl 4:S55-9. doi: 10.1038/ijo.2008.124.
- Background: PubMed 23796877Chiranthanut N, Teekachunhatean S, Panthong A, Khonsung P, Kanjanapothi D, Lertprasertsuk N. Toxicity evaluation of standardized extract of Gynostemma pentaphyllum Makino. J Ethnopharmacol. 2013 Aug 26;149(1):228-34. doi: 10.1016/j.jep.2013.06.027. Epub 2013 Jun 21.
- BackgroundDallal, G. (2017, July 10). www.Randomization.com. Retrieved from Randomization.com: http://www.randomization.com
- BackgroundDing, Y., Tang, K., Li, F., & et al. (2010). Effects of Gypenosides from Gynostemma pentaphyllum supplementation on exercise-induced fatigue in mice. African Journal of Agricultural Research, 5(6), 707-711.
- BackgroundDiseases, N. I. (n.d.). www.niddk.nih.gov/health-information/weight-management. Retrieved May 6, 2019, from Weight Management: https://www.niddk.nih.gov/health-information/weight-management
- Background: PubMed 25358020El-Marasy SA, Abdallah HM, El-Shenawy SM, El-Khatib AS, El-Shabrawy OA, Kenawy SA. Anti-depressant effect of hesperidin in diabetic rats. Can J Physiol Pharmacol. 2014 Nov;92(11):945-52. doi: 10.1139/cjpp-2014-0281. Epub 2014 Sep 19.
- BackgroundFood and Drug Administration. (2005, March 11). Guidance for Industry on Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Federal Register, 70(140), 1-27. Retrieved from trc.
- Background: PubMed 11746857Garg A, Garg S, Zaneveld LJ, Singla AK. Chemistry and pharmacology of the Citrus bioflavonoid hesperidin. Phytother Res. 2001 Dec;15(8):655-69. doi: 10.1002/ptr.1074.
- Background: PubMed 22576281Gauhar R, Hwang SL, Jeong SS, Kim JE, Song H, Park DC, Song KS, Kim TY, Oh WK, Huh TL. Heat-processed Gynostemma pentaphyllum extract improves obesity in ob/ob mice by activating AMP-activated protein kinase. Biotechnol Lett. 2012 Sep;34(9):1607-16. doi: 10.1007/s10529-012-0944-1. Epub 2012 May 11.
- Background: PubMed 24696423Ghasemi T, Abnous K, Vahdati F, Mehri S, Razavi BM, Hosseinzadeh H. Antidepressant Effect of Crocus sativus Aqueous Extract and its Effect on CREB, BDNF, and VGF Transcript and Protein Levels in Rat Hippocampus. Drug Res (Stuttg). 2015 Jul;65(7):337-43. doi: 10.1055/s-0034-1371876. Epub 2014 Apr 2.
- Background: PubMed 20579522Gout B, Bourges C, Paineau-Dubreuil S. Satiereal, a Crocus sativus L extract, reduces snacking and increases satiety in a randomized placebo-controlled study of mildly overweight, healthy women. Nutr Res. 2010 May;30(5):305-13. doi: 10.1016/j.nutres.2010.04.008.
- Individual participant dataSharing planned: No
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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.
Andrew Swick, Ph.D principal investigator
LIfe Extension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Management Formulation and Handout with Suggestions for Healthy Eating and Overall Health in people with Body Weight, run by Supplement Formulators, Inc. 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 9 inclusion and 34 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 17 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?
Assessment of the mean change in Body Weight from baseline (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04107155, which also lists 53 linked publications.
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 17 Mar 2020; AzTrials last refreshed its copy on 29 Oct 2026.