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

NCT02979717 | Completed

• 1 other identifier: GIL-1653
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

satiety; protein; fiber

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour post-intervention

Secondary Outcomes (3)

• Visual Analog Scale (VAS) Appetite Questionnaire on scale of 0-100

  pre-intervention; 10, 20, 30, 60 min post-intervention

• Visual Analog Scale (VAS) Cravings Questionnaire on scale of 0-100

  pre-intervention; 10, 20, 30, 60 min post-intervention

• Subjective Physical Comfort Questionnaire on scale of 0-100

  pre-intervention; immediately post-intervention; 30 min post-intervention

Study Arms (2)

high protein, high fiber

EXPERIMENTAL

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

Dietary Supplement: High protein, high fiber dietary supplement

Low protein, low fiber

PLACEBO COMPARATOR

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

Other: Low protein, low fiber comparator

Interventions

High protein, high fiber dietary supplement DIETARY_SUPPLEMENT

high protein, high fiber

Low protein, low fiber comparator OTHER

Low protein, low fiber

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Beachbody: lead
• Glycemic Index Laboratories, Inc: collaborator

Study Sites (1)

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (1)

• 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.

  PMID: 29955731 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Thomas Wolever, PhD,DM(Oxon)

  Glycemic Index Laboratories, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 2, 2016
• Study Start: November 23, 2016
• Primary Completion: March 14, 2017
• Study Completion: March 14, 2017
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

CA (1)