An interventional study of Meal replacement shake and Multivitamin and mineral capsules in Body Weight Changes, sponsored by Supplement Formulators, Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Supplement Formulators, Inc. · Not applicable, Interventional, and Health services research
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.
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.
231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.
This study's enrollment of 23 is below the median of 80 across 179 interventional studies indexed under Body Weight Changes.
Browse Body Weight Changes studies →Supplement Formulators, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Primary Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplements administered daily for 52 days with a meal replacement shake administered two days per week for the study duration
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
Multivitamin tablet administered daily for 52 days
Dietary Supplement: Multivitamin and mineral supplement
Meal replacement shake taken two days per week during the modified fasting periods
Drug pages: Geritol · Minerals
Multivitamin/mineral supplement
Wild Fish Oil Concentrate 2000mg, Olive Extract 300mg, Sesame seed lignan extract 10mg/2 softgels
Prebiotic Fiber 1,400 mg/tablet
Clove extract 250mg and maqui berry extract 200mg/capsule
Whole food blend 1000mg/3 capsules
Turmeric 25:1 extract 400mg/capsule
White kidney bean extract 100mg/capsule
Saffron extract 88.25mg/capsule
Ubiquinol 100mg and Fulvic Acid complex 100mg/softgel
Calcium 130mg. hesperidin 500mg and gynostemma extract 450mg/ tablet
Multivitamin and multimineral supplement
Body weight
Time frame: 52 days
hs-CRP
hs-C-reactive protein
Time frame: 52 days
IL-6
Interleukin-6
Time frame: 52 days
IL-8
Interleukin-8
Time frame: 52 days
IL-12
Interleukin-12
Time frame: 52 days
TNF-a
Tumor necrosis factor alpha
Time frame: 52 days
IGF-1
Insulin-like growth factor 1
Time frame: 52 days
IGFBP-1
Insulin-like growth factor binding protein 1
Time frame: 52 days
Total Cholesterol
Time frame: 52 days
LDL-c
LDL Cholesterol
Time frame: 52 days
HDL-c
HDL Cholesterol
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
Plan to share: No
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Geritol · Minerals · Turmeric extract · Crocus sativus flower
Supplement Formulators, Inc.