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Trial record 4 of 32 for:    PREMIUM

The Impact of a High-protein Diet on Metabolism and Gut Microbiome (PREMIUM)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified August 2017 by Carla Prado, University of Alberta
Sponsor:
Collaborator:
Almased Wellness GmbH
Information provided by (Responsible Party):
Carla Prado, University of Alberta
ClinicalTrials.gov Identifier:
NCT03235804
First received: July 27, 2017
Last updated: August 9, 2017
Last verified: August 2017
  Purpose

This study will investigate the effects of a 12-week high-protein diet on individuals with excessive body weight in adult men and women on metabolism and gut microbiome.

This is a randomized, parallel group, single-blind, placebo-controlled clinical trial of a 12-week nutritional intervention. A sample size of n=72 participants will be randomly allocated into one of the following groups:

  • Placebo group (PLA): Participants will maintain their usual dietary intake and consume a portion of cellulose (placebo) twice daily (in two snacks) over 12 weeks;
  • High-protein group (HP): Participants will maintain their usual dietary intake and consume a portion of a yogurt and honey-based soy-protein nutritional supplement twice daily (as two snacks) over 12 weeks.

The following variables will be analysed:

  • Systemic inflammatory biomarkers (high-sensitivity C-reactive protein [hs-CRP], IL-6, IL-8, IL-10, tumor necrosis factor-α [TNF-α] and adiponectin).
  • Energy metabolism (i.e. resting energy expenditure and RQ);
  • Metabolic blood markers [glucose, insulin, lipid panel, PYY, GLP-1, ghrelin, leptin, free glycerol, free fatty acids, and thyroid stimulating hormone (TSH)];
  • Appetite sensations (hunger, satiety, fullness, and prospective food consumption);
  • Body composition;
  • Gut microbiome diversity and composition, specifically taxa that have been associated with health benefits, obesity, and weight loss.

At baseline and after 6 and 12 weeks, individuals will attend our Human Nutrition Research Unit where all assessments will take place. In order to assess participants' adherence and follow-up, dietary intake, body weight and appetite sensations will be assessed weekly during the 12-week intervention period. Additionally, participants will be contacted by phone weekly and reminded to maintain their journal/log.


Condition Intervention
Dietary Modification Dietary Supplement: Yogurt and honey-based soy-protein nutritional supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Impact of a High-protein Diet on Metabolism and Gut Microbiome: a 12-week Study in Individuals With Excessive Body Weight

Resource links provided by NLM:


Further study details as provided by Carla Prado, University of Alberta:

Primary Outcome Measures:
  • Interleukin-6. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in blood interleukin-6 will be assessed at baseline, middle and end of the 12-week dietary intervention period.


Secondary Outcome Measures:
  • Gut microbiome diversity and composition. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in gut microbiome diversity and composition (specifically taxa that have been associated with health benefits, obesity and weight loss) will be assessed at baseline, middle and end of the 12-week dietary intervention period.


Other Outcome Measures:
  • High-sensitivity C-reactive protein. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in blood high-sensitivity C-reactive protein will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Interleukin 8. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in interleukin 8 will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Interleukin 10. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in interleukin 10 will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Tumor necrosis factor-α. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in tumor necrosis factor-α will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Adiponectin. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in adiponectin will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Blood glucose. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in blood glucose will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Insulin. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in insulin will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Lipid panel. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Peptide tyrosine-tyrosine. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in peptide tyrosine-tyrosine will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Glucagon-like peptide 1. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in glucagon-like peptide-1 will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Ghrelin. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in ghrelin will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Leptin. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in leptin will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Free glycerol. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes free glycerol will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Free fatty acids. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in free fatty acids will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Thyroid stimulating hormone. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in thyroid stimulating hormone will be assessed at baseline, middle and end of the 12-week dietary intervention period.

  • Resting energy expenditure. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in resting energy expenditure will be assessed at baseline, middle and end of the 12-week dietary intervention period using a whole body calorimetry unit.

  • Body composition. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in fat mass, lean soft tissue and bone mineral content will be assessed at baseline, middle and end of the 12-week dietary intervention period using dual-energy X-ray absorptiometry.

  • Appetite sensations. [ Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). ]
    Changes in hunger, satiety, fullness, and prospective food consumption will be assessed at baseline, middle and end of the 12-week dietary intervention period using a 100 mm visual analogue scale.


Estimated Enrollment: 72
Anticipated Study Start Date: January 1, 2018
Estimated Study Completion Date: December 31, 2020
Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Participants will be asked to maintain their usual dietary intake over 12 weeks.
Experimental: High-Protein Group
Participants will be asked to maintain their usual dietary intake and consume a portion of a yogurt and honey-based soy-protein nutritional supplement twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern will result in a diet composed of, approximately, 25% of protein, 50% of carbohydrate and 25% of fat of total energy intake. The amount of protein is considered higher that the North American Dietary Pattern (15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).
Dietary Supplement: Yogurt and honey-based soy-protein nutritional supplement
Participants will be asked to maintain their usual dietary intake and consume a portion of a yogurt and honey-based soy-protein supplement twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern will result in a diet composed of, approximately, 25% of protein, 50% of carbohydrate and 25% of fat of total energy intake. The amount of protein is considered higher that the North American Dietary Pattern (15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smoker;
  • Female/Male;
  • Aged 18 to 40 years;
  • Body mass index between 25 and 35 kg/m²;
  • Fasting high-sensitivity C-reactive protein levels between 3-10 mg/L;
  • Maintaining current levels of physical activity throughout the study.

Exclusion Criteria:

  • Previously been diagnosed with any chronic disease;
  • Taking any medications which may alter energy metabolism or body composition;
  • Lactose, gluten and/or soy allergic/intolerant;
  • Follow a vegetarian, vegan or restrictive dietary pattern;
  • Pregnant or lactating;
  • Used nutritional supplements in the past two months;
  • Perform over three hours of vigorous physical activity per week;
  • A nuclear medicine scan or injection of an X-ray dye in the past week;
  • A barium test/exam in the last two weeks;
  • Suffer from claustrophobia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03235804

Contacts
Contact: Camila L Pinto, MSc (780) 492-4182 camila@ualberta.ca

Sponsors and Collaborators
University of Alberta
Almased Wellness GmbH
Investigators
Principal Investigator: Jens Walter, PhD University of Alberta
Principal Investigator: Carla M Prado, PhD University of Alberta
Principal Investigator: Arya Sharma, PhD University of Alberta
  More Information

Responsible Party: Carla Prado, Assistant Professor / CAIP Chair in Nutrition, Food and Health, CIHR New Investigator, Director of the Human Nutrition Research Unit., University of Alberta
ClinicalTrials.gov Identifier: NCT03235804     History of Changes
Other Study ID Numbers: Pro00070712
Study First Received: July 27, 2017
Last Updated: August 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carla Prado, University of Alberta:
High-protein diet
Inflammation
Energy metabolism
Body composition
Gut microbiome

ClinicalTrials.gov processed this record on August 18, 2017