Body Weight ChangesNCT03372109
Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain
A study testing Meal replacement shake, Multivitamin and mineral capsules and Fish oil with sesame lignans and olive extract softgel in people with Body Weight Changes, run by Supplement Formulators, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of repeated periods of modified fasting in support of healthy weight management and prevention of weight gain over the winter holiday period (mid-November to early January) in comparison to regular diet and activity. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- Meal replacement shake, Multivitamin and mineral capsules and Fish oil with sesame lignans and olive extract softgel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 22 Mar 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ambulatory, male or female, 21-65 years of age
- A body mass index (BMI) of 23-34.9
- Generally healthy and having no significant difficulty with digestion of food
- Has been generally weight stable for the past six months
- Willing to discontinue use of any (non-study) multivitamin or Vitamin D supplements during the study
- Willing and able to give written informed consent
Show all 41Show fewer
- Clearly understands the procedures and study requirements
- 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
- Primary Exclusion Criteria:
- Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug in the past 30 days
- History of allergy or sensitivity to any component of the study products including milk, soy and almonds
- Donation of blood with 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
- Having been diagnosed, received medical treatment or taking medication daily for the following medical condition(s):
- Diabetes mellitus
- Eating disorder
- Acute or chronic inflammatory disease or autoimmune disease
- Cardiovascular disease
- 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)
- Psychiatric disorder
- Neurologic condition/disease
- Cancer (unless skin cancer other than melanoma which has been treated > 3 years prior to Baseline/screening)
- Active or chronic liver, pancreatic and kidney disease
- Blood coagulation disorder
- Other condition or medication use that would preclude participation in the study in the judgment of the investigator/sub-investigator (Sub-I)
- Currently taking or having taken within the 30 days prior to screening/baseline any hormone replacement therapy (including DHEA (dehydroepiandrosterone), 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)
- Currently taking any of the nutritional supplements used in the study and unwilling to discontinue use at least 14 days prior to screening.
- Currently taking a medication or nutritional supplement specifically for weight loss and unwilling to discontinue use 14 days prior to the first dosing of study supplements
- Currently participating in a weight loss program and unwilling to discontinue participation prior to enrollment into the study
- Currently taking an anti-coagulant, anti-platelet medication or a glucose lowering medication
- 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 ULN (upper limit of normal), AST/SGOT(aspartate aminotransferase/serum glutamin oxaloacetic transaminase) and ALT/SGPT (alanine aminotransferase/serum glutamic pyruvic transaminase) > 2.5 x ULN, serum creatinine > 1.5 mg/dL, blood glucose < 85 mg/dL or > 125 mg/dL, and TSH(thyroid stimulating hormone) > 4.12 µIU/mL, 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
- 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.
Who cannot join
None listed.
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 Randomized Controlled Trial to Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain in Overweight But Generally Healthy Adults Over the Winter Holiday Period
The purpose of this study is to assess the effects of repeated periods of modified fasting in support of healthy weight management and prevention of weight gain over the winter holiday period (mid-November to early January) in comparison to regular diet and activity.
Read the detailed description
This study is a randomized, placebo-controlled trial in which subjects assigned to the modified fasting cohort will undergo consecutive weekly cycles of modified fasting for two consecutive days.
The primary objective is to assess the effects of repeated periods of modified fasting on body weight.
The secondary objectives include assessment of the effects of modified fasting on percent body fat, waist circumference and fasting levels of hs-CRP (hs-C-reactive protein), IL-6 (Interleukin-6), IL-8 (interleukin-8), IL-12 (interleukin-12), TNF-a (tumor necrosis factor-alpha), IGF-1 (insulin-like growth factor 1), IGFBP-1 (insulin-like growth factor-binding protein 1) , Total Cholesterol, LDL cholesterol, HDL cholesterol, Glucose, Triglyceride, Insulin, Vitamin-D, 25-Hydroxy,
Participants will undergo assessments of blood tests, vital signs, BMI, body weight, waist circumference and percent body fat.
- Conditions
- Body Weight Changes
- Being tested
- Meal replacement shake, Multivitamin and mineral capsules, Fish oil with sesame lignans and olive extract softgel, Prebiotic Chewable tablet, Clove Extract and Maqui Berry extract capsule
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal replacement shakeDietary supplement
Meal replacement shake taken two days per week during the modified fasting periods
Multivitamin and mineral capsulesDietary supplement
Multivitamin/mineral supplement
Fish oil with sesame lignans and olive extract softgelDietary supplement
Wild Fish Oil Concentrate 2000mg, Olive Extract 300mg, Sesame seed lignan extract 10mg/2 softgels
Prebiotic Chewable tabletDietary supplement
Prebiotic Fiber 1,400 mg/tablet
Clove Extract and Maqui Berry extract capsuleDietary supplement
Clove extract 250mg and maqui berry extract 200mg/capsule
.Whole Food Blend capsuleDietary supplement
Whole food blend 1000mg/3 capsules
Turmeric extract capsuleDietary supplement
Turmeric 25:1 extract 400mg/capsule
European White Kidney Bean capsuleDietary supplement
White kidney bean extract 100mg/capsule
Saffron extract capsuleDietary supplement
Saffron extract 88.25mg/capsule
Ubiquinol with Fulvic acid complex softgelDietary supplement
Ubiquinol 100mg and Fulvic Acid complex 100mg/softgel
Calcium with Hesperidin and gynostemma extract tabletDietary supplement
Calcium 130mg. hesperidin 500mg and gynostemma extract 450mg/ tablet
Multivitamin and mineral supplementDietary supplement
Multivitamin and multimineral supplement
| Study group | Role | What they receive |
|---|---|---|
| Modified Fasting Arm | Active comparator | Dietary Supplements administered daily for 52 days with a meal replacement shake administered two days per week for the study duration Receives: Dietary Supplement: Meal replacement shake; Dietary Supplement: Multivitamin and mineral capsules; Dietary Supplement: Fish oil with sesame lignans and olive extract softgel; Dietary Supplement: Prebiotic Chewable tablet; Dietary Supplement: Clove Extract and Maqui Berry extract capsule; Dietary Supplement: .Whole Food Blend capsule; Dietary Supplement: Turmeric extract capsule; Dietary Supplement: European White Kidney Bean capsule; Dietary Supplement: Saffron extract capsule; Dietary Supplement: Ubiquinol with Fulvic acid complex softgel; Dietary Supplement: Calcium with Hesperidin and gynostemma extract tablet |
| Placebo | Placebo comparator | Multivitamin tablet administered daily for 52 days Receives: Dietary Supplement: Multivitamin and mineral supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 52 days
Secondary outcomes (16)
hs-CRP
hs-C-reactive protein
Measured: 52 days
IL-6
Interleukin-6
Measured: 52 days
IL-8
Interleukin-8
Measured: 52 days
IL-12
Interleukin-12
Measured: 52 days
TNF-a
Tumor necrosis factor alpha
Measured: 52 days
IGF-1
Insulin-like growth factor 1
Measured: 52 days
IGFBP-1
Insulin-like growth factor binding protein 1
Measured: 52 days
Total Cholesterol
Measured: 52 days
LDL-c
LDL Cholesterol
Measured: 52 days
HDL-c
HDL Cholesterol
Measured: 52 days
Glucose
Measured: 52 days
Triglycerides
Measured: 52 days
Insulin
Measured: 52 days
Vitamin D, 25-Hydroxy
Measured: 52 days
Percent body fat
Measured: 52 days
Waist circumference
Measured: 52 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start14 Nov 2017
- Primary completion23 Jan 2018
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (118)Papers the sponsor has linked to this study.
- Other trials for Body Weight ChangesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supplement Formulators, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Joyal, M.D., Principal investigator, LIfe Extension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372109
- Sponsor's protocol ID
- CL092
- Status last verified
- Apr 2018
- First submitted
- 7 Dec 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarado J, Schoenlau F, Leschot A, Salgad AM, Vigil Portales P. Delphinol(R) standardized maqui berry extract significantly lowers blood glucose and improves blood lipid profile in prediabetic individuals in three-month clinical trial. Panminerva Med. 2016 Sep;58(3 Suppl 1):1-6.
PubMed 27820958Alvarado JL, Leschot A, Olivera-Nappa A, Salgado AM, Rioseco H, Lyon C, Vigil P. Delphinidin-Rich Maqui Berry Extract (Delphinol(R)) Lowers Fasting and Postprandial Glycemia and Insulinemia in Prediabetic Individuals during Oral Glucose Tolerance Tests. Biomed Res Int. 2016;2016:9070537. doi: 10.1155/2016/9070537. Epub 2016 Nov 29.
PubMed 28025651Aranganathan 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 19632289Bales CW, Kraus WE. Caloric restriction: implications for human cardiometabolic health. J Cardiopulm Rehabil Prev. 2013 Jul-Aug;33(4):201-8. doi: 10.1097/HCR.0b013e318295019e.
PubMed 23748374Barger JL, Kayo T, Pugh TD, Prolla TA, Weindruch R. Short-term consumption of a resveratrol-containing nutraceutical mixture mimics gene expression of long-term caloric restriction in mouse heart. Exp Gerontol. 2008 Sep;43(9):859-66. doi: 10.1016/j.exger.2008.06.013. Epub 2008 Jul 9.
PubMed 18657603Barrett ML, Udani JK. A proprietary alpha-amylase inhibitor from white bean (Phaseolus vulgaris): a review of clinical studies on weight loss and glycemic control. Nutr J. 2011 Mar 17;10:24. doi: 10.1186/1475-2891-10-24.
PubMed 21414227Bitler C, Matt K, Irving M, et al. Olive extract supplement decreases pain and improves daily activities in adults with osteoarthritis and decreases plasma homocysteine in those with rheumatoid arthritis. Nutrition Research. 27(8):470-77.2007
Bonakdar RA, Guarneri E. Coenzyme Q10. Am Fam Physician. 2005 Sep 15;72(6):1065-70.
PubMed 16190504Buchowski MS, Hongu N, Acra S, Wang L, Warolin J, Roberts LJ 2nd. Effect of modest caloric restriction on oxidative stress in women, a randomized trial. PLoS One. 2012;7(10):e47079. doi: 10.1371/journal.pone.0047079. Epub 2012 Oct 5.
PubMed 23071718Carai MA, Fantini N, Loi B, Colombo G, Riva A, Morazzoni P. Potential efficacy of preparations derived from Phaseolus vulgaris in the control of appetite, energy intake, and carbohydrate metabolism. Diabetes Metab Syndr Obes. 2009 Sep 7;2:145-53. doi: 10.2147/dmsott.s4236.
PubMed 21437128Carling 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 18719600Cerda B, Ceron JJ, Tomas-Barberan FA, Espin JC. Repeated oral administration of high doses of the pomegranate ellagitannin punicalagin to rats for 37 days is not toxic. J Agric Food Chem. 2003 May 21;51(11):3493-501. doi: 10.1021/jf020842c.
PubMed 12744688Chan DC, Watts GF, Mori TA, Barrett PH, Redgrave TG, Beilin LJ. Randomized controlled trial of the effect of n-3 fatty acid supplementation on the metabolism of apolipoprotein B-100 and chylomicron remnants in men with visceral obesity. Am J Clin Nutr. 2003 Feb;77(2):300-7. doi: 10.1093/ajcn/77.2.300.
PubMed 12540386Cheng AL, Hsu CH, Lin JK, Hsu MM, Ho YF, Shen TS, Ko JY, Lin JT, Lin BR, Ming-Shiang W, Yu HS, Jee SH, Chen GS, Chen TM, Chen CA, Lai MK, Pu YS, Pan MH, Wang YJ, Tsai CC, Hsieh CY. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. Anticancer Res. 2001 Jul-Aug;21(4B):2895-900.
PubMed 11712783Chen HH, Chen YK, Chang HC, et al. Immunomodulatory Effects of Xylooligosaccharides. Food Science and Technology Research. 18(2):195-9. 2012.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain in Overweight But Generally Healthy Adults Over the Winter Holiday Period
- ClinicalTrials.gov ID
- NCT03372109
- Acronym / sponsor ID
- CL092
- Conditions
- Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Supplement Formulators, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 13 Dec 2017 (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 assess the effects of repeated periods of modified fasting in support of healthy weight management and prevention of weight gain over the winter holiday period (mid-November to early January) in comparison to regular diet and activity.
Detailed description
This study is a randomized, placebo-controlled trial in which subjects assigned to the modified fasting cohort will undergo consecutive weekly cycles of modified fasting for two consecutive days.
The primary objective is to assess the effects of repeated periods of modified fasting on body weight.
The secondary objectives include assessment of the effects of modified fasting on percent body fat, waist circumference and fasting levels of hs-CRP (hs-C-reactive protein), IL-6 (Interleukin-6), IL-8 (interleukin-8), IL-12 (interleukin-12), TNF-a (tumor necrosis factor-alpha), IGF-1 (insulin-like growth factor 1), IGFBP-1 (insulin-like growth factor-binding protein 1) , Total Cholesterol, LDL cholesterol, HDL cholesterol, Glucose, Triglyceride, Insulin, Vitamin-D, 25-Hydroxy,
Participants will undergo assessments of blood tests, vital signs, BMI, body weight, waist circumference and percent body fat.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Fasting Arm | Active comparator | Dietary Supplement: Meal replacement shake, Dietary Supplement: Multivitamin and mineral capsules, Dietary Supplement: Fish oil with sesame lignans and olive extract softgel, Dietary Supplement: Prebiotic Chewable tablet, Dietary Supplement: Clove Extract and Maqui Berry extract capsule, Dietary Supplement: .Whole Food Blend capsule, Dietary Supplement: Turmeric extract capsule, Dietary Supplement: European White Kidney Bean capsule, Dietary Supplement: Saffron extract capsule, Dietary Supplement: Ubiquinol with Fulvic acid complex softgel, Dietary Supplement: Calcium with Hesperidin and gynostemma extract tabletDietary Supplements administered daily for 52 days with a meal replacement shake administered two days per week for the study duration |
| Placebo | Placebo comparator | Dietary Supplement: Multivitamin and mineral supplementMultivitamin tablet administered daily for 52 days |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- Ambulatory, male or female, 21-65 years of age
- A body mass index (BMI) of 23-34.9
- Generally healthy and having no significant difficulty with digestion of food
- Has been generally weight stable for the past six months
- Willing to discontinue use of any (non-study) multivitamin or Vitamin D supplements during the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Meal replacement shakeMeal replacement shake taken two days per week during the modified fasting periods | Dietary supplement | Modified Fasting Arm |
| Multivitamin and mineral capsulesMultivitamin/mineral supplement | Dietary supplement | Modified Fasting Arm |
| Fish oil with sesame lignans and olive extract softgelWild Fish Oil Concentrate 2000mg, Olive Extract 300mg, Sesame seed lignan extract 10mg/2 softgels | Dietary supplement | Modified Fasting Arm |
| Prebiotic Chewable tabletPrebiotic Fiber 1,400 mg/tablet | Dietary supplement | Modified Fasting Arm |
| Clove Extract and Maqui Berry extract capsuleClove extract 250mg and maqui berry extract 200mg/capsule | Dietary supplement | Modified Fasting Arm |
| .Whole Food Blend capsuleWhole food blend 1000mg/3 capsules | Dietary supplement | Modified Fasting Arm |
| Turmeric extract capsuleTurmeric 25:1 extract 400mg/capsule | Dietary supplement | Modified Fasting Arm |
| European White Kidney Bean capsuleWhite kidney bean extract 100mg/capsule | Dietary supplement | Modified Fasting Arm |
| Saffron extract capsuleSaffron extract 88.25mg/capsule | Dietary supplement | Modified Fasting Arm |
| Ubiquinol with Fulvic acid complex softgelUbiquinol 100mg and Fulvic Acid complex 100mg/softgel | Dietary supplement | Modified Fasting Arm |
| Calcium with Hesperidin and gynostemma extract tabletCalcium 130mg. hesperidin 500mg and gynostemma extract 450mg/ tablet | Dietary supplement | Modified Fasting Arm |
| Multivitamin and mineral supplementMultivitamin and multimineral supplement | Dietary supplement | Placebo |
Primary outcome
Body weight
Time frame: 52 days
16 secondary outcomes
hs-CRP
Time frame: 52 days
IL-6
Time frame: 52 days
IL-8
Time frame: 52 days
IL-12
Time frame: 52 days
TNF-a
Time frame: 52 days
IGF-1
Time frame: 52 days
IGFBP-1
Time frame: 52 days
Total Cholesterol
Time frame: 52 days
LDL-c
Time frame: 52 days
HDL-c
Time frame: 52 days
Glucose
Time frame: 52 days
Triglycerides
Time frame: 52 days
Insulin
Time frame: 52 days
Vitamin D, 25-Hydroxy
Time frame: 52 days
Percent body fat
Time frame: 52 days
Waist circumference
Time frame: 52 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 Apr 2018.
- Background: PubMed 27820958Alvarado J, Schoenlau F, Leschot A, Salgad AM, Vigil Portales P. Delphinol(R) standardized maqui berry extract significantly lowers blood glucose and improves blood lipid profile in prediabetic individuals in three-month clinical trial. Panminerva Med. 2016 Sep;58(3 Suppl 1):1-6.
- Background: PubMed 28025651Alvarado JL, Leschot A, Olivera-Nappa A, Salgado AM, Rioseco H, Lyon C, Vigil P. Delphinidin-Rich Maqui Berry Extract (Delphinol(R)) Lowers Fasting and Postprandial Glycemia and Insulinemia in Prediabetic Individuals during Oral Glucose Tolerance Tests. Biomed Res Int. 2016;2016:9070537. doi: 10.1155/2016/9070537. Epub 2016 Nov 29.
- 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 23748374Bales CW, Kraus WE. Caloric restriction: implications for human cardiometabolic health. J Cardiopulm Rehabil Prev. 2013 Jul-Aug;33(4):201-8. doi: 10.1097/HCR.0b013e318295019e.
- Background: PubMed 18657603Barger JL, Kayo T, Pugh TD, Prolla TA, Weindruch R. Short-term consumption of a resveratrol-containing nutraceutical mixture mimics gene expression of long-term caloric restriction in mouse heart. Exp Gerontol. 2008 Sep;43(9):859-66. doi: 10.1016/j.exger.2008.06.013. Epub 2008 Jul 9.
- Background: PubMed 21414227Barrett ML, Udani JK. A proprietary alpha-amylase inhibitor from white bean (Phaseolus vulgaris): a review of clinical studies on weight loss and glycemic control. Nutr J. 2011 Mar 17;10:24. doi: 10.1186/1475-2891-10-24.
- BackgroundBitler C, Matt K, Irving M, et al. Olive extract supplement decreases pain and improves daily activities in adults with osteoarthritis and decreases plasma homocysteine in those with rheumatoid arthritis. Nutrition Research. 27(8):470-77.2007
- Background: PubMed 16190504Bonakdar RA, Guarneri E. Coenzyme Q10. Am Fam Physician. 2005 Sep 15;72(6):1065-70.
- Background: PubMed 23071718Buchowski MS, Hongu N, Acra S, Wang L, Warolin J, Roberts LJ 2nd. Effect of modest caloric restriction on oxidative stress in women, a randomized trial. PLoS One. 2012;7(10):e47079. doi: 10.1371/journal.pone.0047079. Epub 2012 Oct 5.
- Background: PubMed 21437128Carai MA, Fantini N, Loi B, Colombo G, Riva A, Morazzoni P. Potential efficacy of preparations derived from Phaseolus vulgaris in the control of appetite, energy intake, and carbohydrate metabolism. Diabetes Metab Syndr Obes. 2009 Sep 7;2:145-53. doi: 10.2147/dmsott.s4236.
- 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 12744688Cerda B, Ceron JJ, Tomas-Barberan FA, Espin JC. Repeated oral administration of high doses of the pomegranate ellagitannin punicalagin to rats for 37 days is not toxic. J Agric Food Chem. 2003 May 21;51(11):3493-501. doi: 10.1021/jf020842c.
- AIBMR.GRAS Self-determination Inventory Database. Coenzyme Q10.Link provided by the sponsor.
- CentrumLink provided by the sponsor.
- Omega-3 Fatty AcidsLink provided by the sponsor.
- Two-Per-Day capsulesLink provided by the sponsor.
- 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.
Steven Joyal, M.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 Meal replacement shake, Multivitamin and mineral capsules and Fish oil with sesame lignans and olive extract softgel in people with Body Weight Changes, 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 41 inclusion and 0 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 Apr 2018. 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: 52 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 NCT03372109, which also lists 118 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 Apr 2018.