Study to Evaluate the Effects of a Weight Management Program on Body Weight

Completed · Not applicable · Has a placebo group

Conditions studied: Body Weight

In brief

The purpose of the study is to assess the safety and effectiveness of the Weight Management Program on body weight

Key facts

Study ID

NCT04107155

Run by

Supplement Formulators, Inc.

People needed

54

Starts

2019-07-23

Expected to finish

2019-12-20

Last updated by the study team

2020-03-17

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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)

Where it is running

• Life Extension Clinical Research, Inc. — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

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