The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
MERITS
1 other identifier
interventional
72
1 country
1
Brief Summary
The prevalence of overweight and lifestyle related diseases such as cardiovascular disease (CVD) and type 2 diabetes (T2D) is increasing world wide. The metabolic syndrome (MeS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and elevated blood sugar. MeS is associated with an increased risk of developing CVD and T2D. Dietary fibers and whey protein have independently shown beneficial effects on several of these risk factors in previous studies. Whey protein is furthermore seen to show positive effects on bone turnover. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 19, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2017
CompletedJuly 17, 2017
July 1, 2017
1.2 years
August 19, 2016
July 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postprandial triglyceride response
Postprandial triglyceride response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and at 12 weeks.
Secondary Outcomes (54)
24 hours blood pressure (BP)
Performed at baseline and week 12
24 hours augmentation Index (AI)
Performed at baseline and week 12
Respiratory Exchange Ratio
Meal test: -30 and 140 min. Performed at baseline and week 12.
Body composition
Performed at baseline and week 12
Postprandial apolipoprotein B48 response
Meal test: -15, 0, 60, 240, 360 min. Performed at baseline and at 12 weeks.
- +49 more secondary outcomes
Study Arms (4)
HP/HF
EXPERIMENTALWhey protein powder / High fiber bread
HP/LF
EXPERIMENTALWhey protein powder / Low fiber bread
LP/HF
EXPERIMENTALMaltodextrin powder / High fiber bread
LP/LF
EXPERIMENTALMaltodextrin powder / Low fiber bread
Interventions
Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)
Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)
Eligibility Criteria
You may qualify if:
- Waist circumference ≥ 80 cm (women)/94 cm (men)
- Age ≥40 years
You may not qualify if:
- Significant cardiovascular, renal or endocrine disease
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospitallead
- University of Aarhuscollaborator
- Rigshospitalet, Denmarkcollaborator
- University of California, Daviscollaborator
- University of Copenhagencollaborator
Study Sites (1)
Aarhus University Hospital, Dep. of clinical nutrition research
Aarhus, 8000, Denmark
Related Publications (1)
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.
PMID: 35422766DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Søren Gregersen, MD, ph.d.
Aarhus University Hospital
- STUDY CHAIR
Knud Erik B. Knudsen, Professor
Department of Animal Science, University of Aarhus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician, associate professor, ph.d.
Study Record Dates
First Submitted
August 19, 2016
First Posted
October 13, 2016
Study Start
May 1, 2016
Primary Completion
June 29, 2017
Study Completion
June 29, 2017
Last Updated
July 17, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share