OverweightNCT03057873
The Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat Loss
A study testing High protein, high fiber dietary supplement in people with Overweight, run by Beachbody at 3 sites in 2 countries.
Trial summary
The objective of this study is to investigate the effect of a high protein, high fiber dietary supplement on weight and fat loss in healthy overweight adults. Half of participants will receive a high protein, high fiber supplement twice a day for 12 weeks, and half of the subjects will receive a placebo (that contains… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- High protein, high fiber dietary supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 13 Feb 2017to 25 Oct 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female of 25-50 years of age
- If female, the subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result at screening. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) for at least 3 months
- Double-barrier method
- Non-hormonal IUDs
Show all 15Show fewer
- Hormonal IUD methods must be a stable dose for at least 3 months
- Vasectomy of partner
- Non-heterosexual lifestyle
- A BMI between 27.0 - <35.0 kg/m2 (inclusive). Subjects must meet exactly the inclusion BMI at screening, or be screen failed. Subjects who meet the BMI requirement at screening and present at run-in with a BMI of <27.0 or >35 kg/m2 will be counselled.
- Subjects that have had a stable weight for the past 6 months. A stable weight is defined as not having gained or lost more than 5 kg of body weight throughout the past 6 months (cycling of weight, for example, continuously up and down anything less than 5 kg is considered stable)
- Agreement to comply with dietary recommendations from nutritionist throughout the duration of the study that include a 500 kcal energy deficit from their predicted total energy requirements
- Agrees to fully comply with all study procedures
- Has given voluntary written and informed consent to participate in the study
- Determined to be healthy as per laboratory parameters and physical examination
Who cannot join
- Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study
- Subjects who are smokers (tobacco, e-cigarettes) or have been a smoker within the past 1 year from screening
- Individuals who carry an epi-pen, or those with a diagnosed allergy or who believe that they have an allergy to milk or milk products, crustacean shellfish, tree nuts, or peanuts
- Individuals with a severe allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients
- The use of prescription, over-the-counter health products, or natural health products/dietary supplements being taken for weight loss, cholesterol levels, or blood pressure within 4 weeks of screening
- Subjects with a history of eating disorders
Show all 32Show fewer
- Current participation or participation within the last 3 months in any weight loss program or diet (for example Weight Watchers, Jenny Craig, DASH diet, Atkins, Mediterranean etc.)
- Medical history of thyroid disorders except for subjects diagnosed with hypothyroid and have been on stable medication for at least the last 3 months prior to enrollment. All subject with medical history of hyperthyroid are excluded
- Medical history of hypercholesterolipidemia
- Use of cholesterol lowering prescription drugs within the last 6 months
- Fasting TGs ≥ 200 mg/dL (2.26 mmol/L) or a fasting total cholesterol ≥ 240 mg/dL (6.216 mmol/L)
- Fasting glucose ≥ 126 mg/dL
- Hypertension defined as untreated systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg, or the use of prescription high blood pressure/hypertension medications within the last 6 months
- Type I or Type II diabetes or use of diabetes medication in a preventative setting.
- History of gastrointestinal dysfunction or surgery that may influence digestion or absorption
- Chronic inflammation or structural abnormality, including history of, of the digestive tract (inflammatory bowel disease, celiac disease, chronic diarrhea, chronic constipation, duodenal or gastric ulcer, gastric retention or obstruction, Gastroesophageal reflux disease (GERD), or symptomatic cholelithiasis)
- Subjects who have a history of colorectal cancer, bowel resection, rectocele, or colostomy
- Immunocompromised individuals such as subjects that have undergone organ transplantation, those with rheumatoid arthritis, or subjects diagnosed with human immunodeficiency virus (HIV)
- Unstable medical conditions that in the opinion of the Qualified Investigator preclude the subject from participating in the study
- Anti-anxiety and anti-psychotic medications will be assessed by the MD on a case by case basis
- Alcohol use > 2 standard alcoholic drinks per day
- Alcohol or drug abuse within the last 6 months
- Use of medicinal marijuana
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative
- Subjects with metal fixation plates or screws from a previous surgery
- Clinically significant abnormal laboratory results at screening
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study supplement ingredients
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
- Unwilling or unable to comply with study timeline and procedures
- Individuals who do not like the taste of chocolate or shake type drinks
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
KGK Synergize Inc.
London, Ontario, N6A 58R
GI Labs, Inc.
Toronto, Ontario, M5C 2N8
United States1 site
Great Lakes Clinical Trials (of MB Clinical Research and Consulting, LLC)
Chicago, Illinois, 60630
About this study
Official title: A Double Blind, Placebo Controlled Parallel Study to Investigate the Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat Loss in Healthy Overweight Adults
The objective of this study is to investigate the effect of a high protein, high fiber dietary supplement on weight and fat loss in healthy overweight adults. Half of participants will receive a high protein, high fiber supplement twice a day for 12 weeks, and half of the subjects will receive a placebo (that contains the same amount of calories as the supplement) twice a day for 12 weeks.
- Conditions
- Overweight
- Being tested
- High protein, high fiber dietary supplement, Placebo
- Keywords
- protein, fiber, weight loss, fat loss
- Medical subject headings
- Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein, high fiber dietary supplementDietary supplement
Dry powder to be mixed with 10 ounces of cold water
PlaceboDietary supplement
Dry powder to be mixed with 10 ounces of cold water
| Study group | Role | What they receive |
|---|---|---|
| High protein, high fiber | Experimental | Participants receive a high protein, high fiber dietary supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks Receives: Dietary Supplement: High protein, high fiber dietary supplement |
| Low protein, low fiber | Placebo comparator | Participants receive a low protein, low fiber supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (kg)
Body weight measured by clinic study staff at required visits
Measured: Baseline and 12 weeks
Change in body fat percentage (%)
Body fat percentage as determined by dual x-ray absorptiometry (DXA)
Measured: Baseline and 12 weeks
Secondary outcomes (43)
Change in total fat mass (kg)
Body fat mass as determined by DXA
Measured: Baseline and 12 weeks
Change in total lean mass (kg)
Body lean mass as determined by DXA
Measured: Baseline and 12 weeks
Change in percent abdominal fat (%)
Abdominal fat percentage as determined by DXA
Measured: Baseline and 12 weeks
Change in percent android fat (%)
Android fat percentage as determined by DXA
Measured: Baseline and 12 weeks
Change in percent gynoid fat (%)
Gynoid fat percentage as determined by DXA
Measured: Baseline and 12 weeks
Change in percent trunk fat (%)
Trunk fat percentage as determined by DXA
Measured: Baseline and 12 weeks
Change in percent leg fat (%)
Leg fat percentage as determined by DXA
Measured: Baseline and 12 weeks
Change in body weight (kg)
Body weight measured by clinic study staff at required visits
Measured: Baseline and 4 weeks
Change in body weight (kg)
Body weight measured by clinic study staff at required visits
Measured: Baseline and 8 weeks
Change in Waist circumference (cm)
measured with a tape measure at the part of the trunk located midway between the lower costal margin and the iliac crest while the person is standing
Measured: Baseline and 4 weeks
Change in Waist circumference (cm)
measured with a tape measure at the part of the trunk located midway between the lower costal margin and the iliac crest while the person is standing
Measured: Baseline and 8 weeks
Change in Waist circumference (cm)
measured with a tape measure at the part of the trunk located midway between the lower costal margin and the iliac crest while the person is standing
Measured: Baseline and 12 weeks
Change in Hip circumference (cm)
measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)
Measured: Baseline and 4 weeks
Change in Hip circumference (cm)
measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)
Measured: Baseline and 8 weeks
Change in Hip circumference (cm)
measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)
Measured: Baseline and 12 weeks
Change in Waist to hip ratio
Ratio of waist circumference to hip circumference
Measured: Baseline and 4 weeks
Change in Waist to hip ratio
Ratio of waist circumference to hip circumference
Measured: Baseline and 8 weeks
Change in Waist to hip ratio
Ratio of waist circumference to hip circumference
Measured: Baseline and 12 weeks
Change in Blood leptin (ng/mL)
Fasting level of leptin in the blood
Measured: Baseline and 12 weeks
Change in Blood adiponectin (mcg/mL)
Fasting level of adiponectin in the blood
Measured: Baseline and 12 weeks
Change in Total cholesterol (mg/dL)
Fasting level of total cholesterol in blood
Measured: Baseline and 4 weeks
Change in Total cholesterol (mg/dL)
Fasting level of total cholesterol in blood
Measured: Baseline and 8 weeks
Change in Total cholesterol (mg/dL)
Fasting level of total cholesterol in blood
Measured: Baseline and 12 weeks
Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
Fasting level of LDL cholesterol in blood
Measured: Baseline and 4 weeks
Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
Fasting level of LDL cholesterol in blood
Measured: Baseline and 8 weeks
Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
Fasting level of LDL cholesterol in blood
Measured: Baseline and 12 weeks
Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
Fasting level of HDL cholesterol in blood
Measured: Baseline and 4 weeks
Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
Fasting level of HDL cholesterol in blood
Measured: Baseline and 8 weeks
Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
Fasting level of HDL cholesterol in blood
Measured: Baseline and 12 weeks
Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
Fasting level of Ox-LDL cholesterol in blood
Measured: Baseline and 4 weeks
Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
Fasting level of Ox-LDL cholesterol in blood
Measured: Baseline and 8 weeks
Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
Fasting level of Ox-LDL cholesterol in blood
Measured: Baseline and 12 weeks
Change in triglycerides (mg/dL)
Fasting level of triglycerides in blood
Measured: Baseline and 4 weeks
Change in triglycerides (mg/dL)
Fasting level of triglycerides in blood
Measured: Baseline and 8 weeks
Change in triglycerides (mg/dL)
Fasting level of triglycerides in blood
Measured: Baseline and 12 weeks
Change in Insulin (IU)
Fasting level of insulin in blood
Measured: Baseline and 4 weeks
Change in Insulin (IU)
Fasting level of insulin in blood
Measured: Baseline and 8 weeks
Change in Insulin (IU)
Fasting level of insulin in blood
Measured: Baseline and 12 weeks
Change in Glucose (mmol/L)
Fasting level of glucose in blood
Measured: Baseline and 4 weeks
Change in Glucose (mmol/L)
Fasting level of glucose in blood
Measured: Baseline and 8 weeks
Change in Glucose (mmol/L)
Fasting level of glucose in blood
Measured: Baseline and 12 weeks
Change in blood glycated haemoglobin (HbA1c) (mmol/mol)
Fasting level of HbA1c in blood
Measured: Baseline and 12 weeks
Change in gut microbiota composition
Genera of bacteria measured in stool samples
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start13 Feb 2017
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beachbody
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc., Glycemic Index Laboratories, Inc, Midwest Biomedical Research
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.Thomas Wolever, MD, PhD, Principal investigator, Glycemic Index Laboratories, IncRupal Trivedi, MD, Principal investigator, Great Lakes Clinical Trials (of MB Clinical Research and Consulting, LLC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057873
- Sponsor's protocol ID
- 15SWHB
- Status last verified
- Jan 2019
- First submitted
- 16 Feb 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Glynn EL, Fleming SA, Edwards CG, Wilson MJ, Evans M, Leidy HJ. Consuming a Protein and Fiber-Based Supplement Preload Promotes Weight Loss and Alters Metabolic Markers in Overweight Adults in a 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial. J Nutr. 2022 Jun 9;152(6):1415-1425. doi: 10.1093/jn/nxac038.
PubMed 35212740
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Parallel Study to Investigate the Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat Loss in Healthy Overweight Adults
- ClinicalTrials.gov ID
- NCT03057873
- Acronym / sponsor ID
- 15SWHB
- Conditions
- Overweight
- Keywords
- protein, fiber, weight loss, fat loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- BeachbodyIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc., Glycemic Index Laboratories, Inc, Midwest Biomedical Research
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 20 Feb 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 objective of this study is to investigate the effect of a high protein, high fiber dietary supplement on weight and fat loss in healthy overweight adults. Half of participants will receive a high protein, high fiber supplement twice a day for 12 weeks, and half of the subjects will receive a placebo (that contains the same amount of calories as the supplement) twice a day for 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High protein, high fiber | Experimental | Dietary Supplement: High protein, high fiber dietary supplementParticipants receive a high protein, high fiber dietary supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks |
| Low protein, low fiber | Placebo comparator | Dietary Supplement: PlaceboParticipants receive a low protein, low fiber supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male or female of 25-50 years of age
- If female, the subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result at screening. Acceptable methods of birth control include:
- A BMI between 27.0 - <35.0 kg/m2 (inclusive). Subjects must meet exactly the inclusion BMI at screening, or be screen failed. Subjects who meet the BMI requirement at screening and present at run-in with a BMI of <27.0 or >35 kg/m2 will be counselled.
- Subjects that have had a stable weight for the past 6 months. A stable weight is defined as not having gained or lost more than 5 kg of body weight throughout the past 6 months (cycling of weight, for example, continuously up and down anything less than 5 kg is considered stable)
Key exclusion criteria (32 listed)
- Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study
- Subjects who are smokers (tobacco, e-cigarettes) or have been a smoker within the past 1 year from screening
- Individuals who carry an epi-pen, or those with a diagnosed allergy or who believe that they have an allergy to milk or milk products, crustacean shellfish, tree nuts, or peanuts
- Individuals with a severe allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients
- The use of prescription, over-the-counter health products, or natural health products/dietary supplements being taken for weight loss, cholesterol levels, or blood pressure within 4 weeks of screening
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 |
|---|---|---|
| High protein, high fiber dietary supplementDry powder to be mixed with 10 ounces of cold water | Dietary supplement | High protein, high fiber |
| PlaceboDry powder to be mixed with 10 ounces of cold water | Dietary supplement | Low protein, low fiber |
Primary outcome
Change in body weight (kg)
Time frame: Baseline and 12 weeks
Body weight measured by clinic study staff at required visits
Change in body fat percentage (%)
Time frame: Baseline and 12 weeks
Body fat percentage as determined by dual x-ray absorptiometry (DXA)
43 secondary outcomes
Change in total fat mass (kg)
Time frame: Baseline and 12 weeks
Change in total lean mass (kg)
Time frame: Baseline and 12 weeks
Change in percent abdominal fat (%)
Time frame: Baseline and 12 weeks
Change in percent android fat (%)
Time frame: Baseline and 12 weeks
Change in percent gynoid fat (%)
Time frame: Baseline and 12 weeks
Change in percent trunk fat (%)
Time frame: Baseline and 12 weeks
Change in percent leg fat (%)
Time frame: Baseline and 12 weeks
Change in body weight (kg)
Time frame: Baseline and 4 weeks
Change in body weight (kg)
Time frame: Baseline and 8 weeks
Change in Waist circumference (cm)
Time frame: Baseline and 4 weeks
Change in Waist circumference (cm)
Time frame: Baseline and 8 weeks
Change in Waist circumference (cm)
Time frame: Baseline and 12 weeks
Change in Hip circumference (cm)
Time frame: Baseline and 4 weeks
Change in Hip circumference (cm)
Time frame: Baseline and 8 weeks
Change in Hip circumference (cm)
Time frame: Baseline and 12 weeks
Change in Waist to hip ratio
Time frame: Baseline and 4 weeks
Change in Waist to hip ratio
Time frame: Baseline and 8 weeks
Change in Waist to hip ratio
Time frame: Baseline and 12 weeks
Change in Blood leptin (ng/mL)
Time frame: Baseline and 12 weeks
Change in Blood adiponectin (mcg/mL)
Time frame: Baseline and 12 weeks
Change in Total cholesterol (mg/dL)
Time frame: Baseline and 4 weeks
Change in Total cholesterol (mg/dL)
Time frame: Baseline and 8 weeks
Change in Total cholesterol (mg/dL)
Time frame: Baseline and 12 weeks
Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
Time frame: Baseline and 4 weeks
Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
Time frame: Baseline and 8 weeks
Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
Time frame: Baseline and 12 weeks
Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
Time frame: Baseline and 4 weeks
Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
Time frame: Baseline and 8 weeks
Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
Time frame: Baseline and 12 weeks
Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
Time frame: Baseline and 4 weeks
Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
Time frame: Baseline and 8 weeks
Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
Time frame: Baseline and 12 weeks
Change in triglycerides (mg/dL)
Time frame: Baseline and 4 weeks
Change in triglycerides (mg/dL)
Time frame: Baseline and 8 weeks
Change in triglycerides (mg/dL)
Time frame: Baseline and 12 weeks
Change in Insulin (IU)
Time frame: Baseline and 4 weeks
Change in Insulin (IU)
Time frame: Baseline and 8 weeks
Change in Insulin (IU)
Time frame: Baseline and 12 weeks
Change in Glucose (mmol/L)
Time frame: Baseline and 4 weeks
Change in Glucose (mmol/L)
Time frame: Baseline and 8 weeks
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 4 Feb 2019.
- Derived from this study: PubMed 35212740Glynn EL, Fleming SA, Edwards CG, Wilson MJ, Evans M, Leidy HJ. Consuming a Protein and Fiber-Based Supplement Preload Promotes Weight Loss and Alters Metabolic Markers in Overweight Adults in a 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial. J Nutr. 2022 Jun 9;152(6):1415-1425. doi: 10.1093/jn/nxac038.
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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.
David Crowley, MD principal investigator
KGK Science Inc.
Thomas Wolever, MD, PhD principal investigator
Glycemic Index Laboratories, Inc
Rupal Trivedi, MD principal investigator
Great Lakes Clinical Trials (of MB Clinical Research and Consulting, LLC)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein, high fiber dietary supplement in people with Overweight, run by Beachbody at 3 sites in 2 countries.
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 15 inclusion and 32 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, 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?
Change in body weight (kg) (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03057873, which also lists 1 linked publication.
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 4 Feb 2019.