Clinical trial NCT02979717: The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: satiety
protein
fiber
Lead sponsor: Beachbody
Sponsor class: INDUSTRY
Collaborators: name: Glycemic Index Laboratories, Inc
First posted: 2016-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant, non-lactating females, 18-50 years of age, inclusive
2. Body mass index (BMI) between 27 and 33 kg/m² inclusive at screening.
3. Blood pressure \< 130/85.
4. Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
5. 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).
6. 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.
7. Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
8. 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.
9. Female subjects are willing to use a contraceptive method to avoid pregnancy during the study period.

Exclusion Criteria:

1. Failure to meet any one of the inclusion criteria
2. Smokers
3. 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.
4. 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.
5. Major trauma or surgical event within 3 months of screening.
6. Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
7. Known intolerance, sensitivity or allergy to any ingredients in the study products.
8. Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc)..
9. Change in body weight of \>3.5kg within 4 weeks of the screening visit.
10. 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.
11. History of cancer in the prior two years, except for non-melanoma skin cancer.
12. Exposure to any non-registered drug product within 30 d prior to screening.
13. Pregnancy or breastfeeding
14. Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional

Primary outcomes:
measure: Energy intake (total kilocalories) at meal subsequent to intervention pre-load
timeFrame: 1 hour post-intervention
Secondary outcomes:
measure: Visual Analog Scale (VAS) Appetite Questionnaire on scale of 0-100
timeFrame: pre-intervention; 10, 20, 30, 60 min post-intervention
measure: Visual Analog Scale (VAS) Cravings Questionnaire on scale of 0-100
timeFrame: pre-intervention; 10, 20, 30, 60 min post-intervention
measure: Subjective Physical Comfort Questionnaire on scale of 0-100
timeFrame: pre-intervention; immediately post-intervention; 30 min post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Inc.
state: Ontario
Study officials:
affiliation: Glycemic Index Laboratories, Inc
name: Thomas Wolever, PhD,DM(Oxon)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.