Overweight and ObesityNCT02979717
The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake
A study testing High protein, high fiber dietary supplement and Low protein, low fiber comparator in people with Overweight and Obesity, run by Beachbody at 1 site in Canada.
Trial summary
The objective of this study is to determine the effect of a high protein, high fiber supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high carbohydrate Control product in healthy overweight and obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- High protein, high fiber dietary supplement and Low protein, low fiber comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2016to 14 Mar 2017
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant, non-lactating females, 18-50 years of age, inclusive
- Body mass index (BMI) between 27 and 33 kg/m² inclusive at screening.
- Blood pressure < 130/85.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to abstain from strenuous exercise, consumption of alcoholic drinks and caffeine-containing food/drinks 24 hours before study days and during study days (until study completion for that day).
- Willing to maintain current dietary supplement (if applicable) use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
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- Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
- Female subjects are willing to use a contraceptive method to avoid pregnancy during the study period.
Who cannot join
- Failure to meet any one of the inclusion criteria
- Smokers
- Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, blood thinners, diuretics, thiazolidinediones, metformin, antibiotics and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of Dr. Wolever, the president of GI labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
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- Known intolerance, sensitivity or allergy to any ingredients in the study products.
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc)..
- Change in body weight of >3.5kg within 4 weeks of the screening visit.
- Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Exposure to any non-registered drug product within 30 d prior to screening.
- Pregnancy or breastfeeding
- Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake in Healthy Overweight and Obese Subjects: An Acute Randomized, Crossover, Double-blind Placebo-controlled Study
The objective of this study is to determine the effect of a high protein, high fiber supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high carbohydrate Control product in healthy overweight and obese subjects. The investigators hypothesize the high protein, high fiber pre-load will result in reduced energy intake at a subsequent meal compared to low protein, low fiber.
- Conditions
- Overweight and Obesity
- Being tested
- High protein, high fiber dietary supplement, Low protein, low fiber comparator
- Keywords
- satiety, protein, fiber
- Medical subject headings
- Overweight, Obesity
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
Low protein, low fiber comparatorOther
| Study group | Role | What they receive |
|---|---|---|
| high protein, high fiber | Experimental | Participants receive a high protein, high fiber dietary supplement pre-load Receives: Dietary Supplement: High protein, high fiber dietary supplement |
| Low protein, low fiber | Placebo comparator | Participants receive a low protein, low fiber isocaloric pre-load Receives: Other: Low protein, low fiber comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake (total kilocalories) at meal subsequent to intervention pre-load
Participants will consume an ad-libitum pizza meal for 30 minutes, 30 minutes following ingestion of the pre-load intervention. At the end of the 30 minute pizza meal, total caloric intake will be recorded.
Measured: 1 hour post-intervention
Secondary outcomes (3)
Visual Analog Scale (VAS) Appetite Questionnaire on scale of 0-100
A standard VAS Appetite questionnaire will be completed by subjects before pre-load intervention, and at indicated time intervals. The 4 questions assess hunger, fullness, desire to eat, and prospective consumption. Each of the questions on the VAS is a 100 mm line anchored at each end with opposing statements. Participants mark a vertical line on the line at a point that they felt reflect their feelings at the moment the test was taken. Scores will be assessed by measuring the distance between the intersection of the vertical line with the line and the left end of the line.
Measured: pre-intervention; 10, 20, 30, 60 min post-intervention
Visual Analog Scale (VAS) Cravings Questionnaire on scale of 0-100
A standard VAS Cravings questionnaire will be completed by subjects before pre-load intervention, and at indicated time intervals. The 4 questions assess cravings for sweet, salty, savory, and fatty. Each of the questions on the VAS is a 100 mm line anchored at each end with opposing statements. Participants mark a vertical line on the line at a point that they felt reflect their feelings at the moment the test was taken. Scores will be assessed by measuring the distance between the intersection of the vertical line with the line and the left end of the line.
Measured: pre-intervention; 10, 20, 30, 60 min post-intervention
Subjective Physical Comfort Questionnaire on scale of 0-100
This questionnaire assesses Gastrointestinal symptoms including Bloating, Belching, Nausea, Diarrhea, and Flatulence. Participants identify if they are currently experiencing the symptom (Yes/No) and if yes, rate the severity of the symptom (Low to High) on a 100 mm scale (0-100). Measures will be made from the left side of the scale, similar to Appetite and Cravings questionnaires.
Measured: pre-intervention; immediately post-intervention; 30 min post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start23 Nov 2016
- Primary completion14 Mar 2017
- Study completion14 Mar 2017
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 Overweight and ObesityStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beachbody
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glycemic Index Laboratories, Inc
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, PhD,DM(Oxon), Principal investigator, Glycemic Index Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979717
- Sponsor's protocol ID
- GIL-1653
- Status last verified
- Mar 2017
- First submitted
- 28 Nov 2016
- Last updated
- 29 Mar 2017
- Results posted
- No
Publications
Sharafi M, Alamdari N, Wilson M, Leidy HJ, Glynn EL. Effect of a High-Protein, High-Fiber Beverage Preload on Subjective Appetite Ratings and Subsequent Ad Libitum Energy Intake in Overweight Men and Women: A Randomized, Double-Blind Placebo-Controlled, Crossover Study. Curr Dev Nutr. 2018 Jun 23;2(6):nzy022. doi: 10.1093/cdn/nzy022. eCollection 2018 Jun.
PubMed 29955731
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake in Healthy Overweight and Obese Subjects: An Acute Randomized, Crossover, Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02979717
- Acronym / sponsor ID
- GIL-1653
- Conditions
- Overweight and Obesity
- Keywords
- satiety, protein, fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- BeachbodyIndustry (pharma, biotech, devices)
- Collaborators
- Glycemic Index Laboratories, Inc
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- 14 Mar 2017 (actual)
- Study completion
- 14 Mar 2017 (actual)
- First posted
- 2 Dec 2016 (estimated)
- 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 determine the effect of a high protein, high fiber supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high carbohydrate Control product in healthy overweight and obese subjects. The investigators hypothesize the high protein, high fiber pre-load will result in reduced energy intake at a subsequent meal compared to low protein, low fiber.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, 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 pre-load |
| Low protein, low fiber | Placebo comparator | Other: Low protein, low fiber comparatorParticipants receive a low protein, low fiber isocaloric pre-load |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or non-pregnant, non-lactating females, 18-50 years of age, inclusive
- Body mass index (BMI) between 27 and 33 kg/m² inclusive at screening.
- Blood pressure < 130/85.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to abstain from strenuous exercise, consumption of alcoholic drinks and caffeine-containing food/drinks 24 hours before study days and during study days (until study completion for that day).
Key exclusion criteria (14 listed)
- Failure to meet any one of the inclusion criteria
- Smokers
- Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, blood thinners, diuretics, thiazolidinediones, metformin, antibiotics and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of Dr. Wolever, the president of GI labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months 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 supplement | Dietary supplement | high protein, high fiber |
| Low protein, low fiber comparator | Other | Low protein, low fiber |
Primary outcome
Energy intake (total kilocalories) at meal subsequent to intervention pre-load
Time frame: 1 hour post-intervention
Participants will consume an ad-libitum pizza meal for 30 minutes, 30 minutes following ingestion of the pre-load intervention. At the end of the 30 minute pizza meal, total caloric intake will be recorded.
3 secondary outcomes
Visual Analog Scale (VAS) Appetite Questionnaire on scale of 0-100
Time frame: pre-intervention; 10, 20, 30, 60 min post-intervention
Visual Analog Scale (VAS) Cravings Questionnaire on scale of 0-100
Time frame: pre-intervention; 10, 20, 30, 60 min post-intervention
Subjective Physical Comfort Questionnaire on scale of 0-100
Time frame: pre-intervention; immediately post-intervention; 30 min post-intervention
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 29 Mar 2017.
- Derived from this study: PubMed 29955731Sharafi M, Alamdari N, Wilson M, Leidy HJ, Glynn EL. Effect of a High-Protein, High-Fiber Beverage Preload on Subjective Appetite Ratings and Subsequent Ad Libitum Energy Intake in Overweight Men and Women: A Randomized, Double-Blind Placebo-Controlled, Crossover Study. Curr Dev Nutr. 2018 Jun 23;2(6):nzy022. doi: 10.1093/cdn/nzy022. eCollection 2018 Jun.
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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.
Thomas Wolever, PhD,DM(Oxon) principal investigator
Glycemic Index Laboratories, Inc
1 site in 1 country: 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 and Low protein, low fiber comparator in people with Overweight and Obesity, run by Beachbody at 1 site in Canada.
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 9 inclusion and 14 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 29 Mar 2017. 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 Canada. 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?
Energy intake (total kilocalories) at meal subsequent to intervention pre-load (time frame: 1 hour post-intervention). 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 NCT02979717, 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 29 Mar 2017.