The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake

NCT ID: NCT02979717

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-23
• Study Completion Date: 2017-03-14

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

high protein, high fiber

Participants receive a high protein, high fiber dietary supplement pre-load

Group Type: EXPERIMENTAL

High protein, high fiber dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Low protein, low fiber

Participants receive a low protein, low fiber isocaloric pre-load

Group Type: PLACEBO_COMPARATOR

Low protein, low fiber comparator

Intervention Type: OTHER

Interventions

High protein, high fiber dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Low protein, low fiber comparator

Intervention Type: OTHER

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Glycemic Index Laboratories, Inc

INDUSTRY

Sponsor Role: collaborator

Beachbody

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Wolever, PhD,DM(Oxon)

Role: PRINCIPAL_INVESTIGATOR

Glycemic Index Laboratories, Inc

Locations

Glycemic Index Laboratories, Inc.

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29955731 (View on PubMed)

Other Identifiers

GIL-1653

Identifier Type: -

Identifier Source: org_study_id