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

NCT04107155 | Completed

• 1 other identifier: CL100
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Body Weight

Outcome Measures

Primary Outcomes (1)

• Assessment of the mean change in Body Weight from baseline

  Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer

  60 days

Secondary Outcomes (17)

• Assessment of the mean change in Waist Circumference from baseline

  60 days

• Assessment of the mean change in Appetite from baseline

  60 days

• Assessment of the mean change in the Total Cholesterol level from baseline

  60 days

• Assessment of the mean change in the Triglyceride level from baseline

  60 days

• Assessment of the mean change in the HDL Cholesterol level from baseline

  60 days

Study Arms (2)

Weight Management Program

EXPERIMENTAL

Dietary Supplement: Saffron extract and Gynostemma extract with hesperidin and a handout with suggestions for healthy eating and overall health

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

Dietary Supplement: Placebo; Other: Handout with Suggestions for Healthy Eating and Overall Health

Interventions

Weight Management Formulation DIETARY_SUPPLEMENT

Saffron extract and Gynostemma extract with hesperidin

Weight Management Program

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Handout with Suggestions for Healthy Eating and Overall Health OTHER

Suggestions for Healthy Eating and Overall Health

Weight Management Program

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Supplement Formulators, Inc.: lead

Study Sites (1)

Life Extension Clinical Research, Inc.

Fort Lauderdale, Florida, 33308, United States

Location

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MeSH Terms

Conditions

Body Weight

Interventions

Suggestion; Diet, Healthy; Health Status

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Andrew Swick, Ph.D

  LIfe Extension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 27, 2019
• Study Start: July 23, 2019
• Primary Completion: November 29, 2019
• Study Completion: December 20, 2019
• Last Updated: March 17, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)