The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
NCT ID: NCT02931630
Last Updated: 2017-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
72 participants
INTERVENTIONAL
2016-05-31
2017-06-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this trial is to investigate whether an increased intake of dietary fibers and whey protein (separately or combined) over a period of 12 weeks will affect the risk markers of MeS and bone turnover in abdominally obese subjects.
A total of 80 people with abdominal obesity will be included. The design is a randomized, double blinded, controlled dietary intervention trial. Subjects are assigned to one of four experimental groups. Each group are provided with test products containing either high or low whey protein and high or low dietary fibers to replace part of their regular diet. The subjects are instructed in how to incorporate the test products in their habitual diets in order to maintain weight stability.
The primary outcome is postprandial lipaemia (PPL) - an independent risk factor of developing CVD. PPL is estimated by performing a standardized high fat meal test during which postprandial level of triglycerides is measured. The authors hypothesize that a diet of high content of whey protein and high dietary fiber during 12 weeks will induce a reduction in PPL.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Protein Quality and Time-factor by Consumption of a Pre-meal on Postprandial Lipemia in Subjects With the Metabolic Syndrome.
NCT02228252
Dose-response Effect of Whey Protein Consumed as Pre-meal on Postprandial Lipaemia in Subjects With Metabolic Syndrome
NCT02087124
Milk Components and Metabolic Syndrome
NCT00785499
Dairy Macronutrient Effects on the Metabolic Syndrome
NCT02885935
Dietary Protein Restriction and Health
NCT06267235
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HP/HF
Whey protein powder / High fiber bread
Whey protein powder
60 g of whey protein powder
High fiber bread
Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)
HP/LF
Whey protein powder / Low fiber bread
Maltodextrin powder
60 g of Maltodextrin powder
Low fiber bread
Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)
LP/HF
Maltodextrin powder / High fiber bread
Maltodextrin powder
60 g of Maltodextrin powder
High fiber bread
Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)
LP/LF
Maltodextrin powder / Low fiber bread
Whey protein powder
60 g of whey protein powder
Low fiber bread
Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Whey protein powder
60 g of whey protein powder
Maltodextrin powder
60 g of Maltodextrin powder
High fiber bread
Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)
Low fiber bread
Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥40 years
Exclusion Criteria
* History of diabetes
* ≥ 3 kg of weight gain or loss within the last 3 months
* Any change in medication within the last month
* Treatment with steroids
* Pregnancy, breastfeeding or planned pregnancy
* Psychiatric history
* Alcohol or drug addiction
* Dietary fiber supplement within the last month
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Aarhus
OTHER
Rigshospitalet, Denmark
OTHER
University of California, Davis
OTHER
University of Copenhagen
OTHER
Aarhus University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Søren Gregersen
Chief physician, associate professor, ph.d.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Søren Gregersen, MD, ph.d.
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Knud Erik B. Knudsen, Professor
Role: STUDY_CHAIR
Department of Animal Science, University of Aarhus
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aarhus University Hospital, Dep. of clinical nutrition research
Aarhus, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fuglsang-Nielsen R, Rakvaag E, Vestergaard P, Hermansen K, Gregersen S, Starup-Linde J. The Effects of 12-Weeks Whey Protein Supplements on Markers of Bone Turnover in Adults With Abdominal Obesity - A Post Hoc Analysis. Front Endocrinol (Lausanne). 2022 Mar 29;13:832897. doi: 10.3389/fendo.2022.832897. eCollection 2022.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MERITS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.