- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07344727
Impact of Haskap Berries on Recovery From High Intensity Resistance Training
The purpose of this clinical trial is to determine how certain food items affect oxidative stress, inflammation, and performance recovery from exercise induced muscle damage in a resistance trained population. The main questions The investigators aim to answer are the following:
- Do Haskaps speed the recovery of oxidative stress and inflammation markers after an intense lower body workout in resistance trained adults?
- Do Haskaps speed the recovery of performance measures after an intense lower body workout in resistance trained adults?
- The data collected in this investigation may also be used to ask additional questions not yet identified. For example, the investigators may use the stored samples to evaluate how the blood metabolites of participants differ before and after intense exercise. These additional questions are called secondary analyses. Please note that no genetic analysis will be conducted and racial and ethnic differences among participants will not be used in any secondary analyses.
Researches will compare Haskap juice to a color, flavor and carbohydrate matched placebo to see if Haskaps speed recovery in inflammation, oxidative stress and performance.
- Participants will be asked to drink either Haskap juice or placebo and follow a low polyphenolic diet
- Participants will perform an intense resistance workout
- Participants will have their blood drawn before and after the workout
- Performance will be analyzed at 24, 48 and 72 hours after the workout
Study Overview
Status
Intervention / Treatment
Detailed Description
The main goal of the clinical trial is to learn more about how the haskap berry impacts the recovery process form intense resistance training. Haskap berries are very high in several compounds that function as antioxidants, such as polyphenols and vitamin C, which have many health promoting effects. For example, antioxidants lower inflammation and oxidative stress, which is known to cause damage to cells, proteins, and DNA. Oxidative stress is a result of excess free radicals, which are unstable molecules that can be created, along with inflammation, during intense exercise. This combination of excessive harmful byproducts in the body can cause soreness and decrease muscle performance experienced after a workout. However, the antioxidants in foods have the ability to neutralize free radicals that are produced and may reduce the time to recover from exercise.
To do this, a parallel, randomized, double blind, placebo controlled clinical trial of Haskap versus a placebo on resistance trained individuals will be completed. Participants will complete an intense workout consisting of barbell back squats and leg extension. Participants will drink either Haskap juice or placebo and follow a low polyphenolic diet for a total of 11 days. Participants will have their blood drawn before supplementation, before, immediately after and 8, 24, 48, and 72 hours after the workout to track recovery of blood markers. Performance will be analyzed via vertical jumps on force plates, maximal voluntary contraction of the quadriceps on a biodex, and speed of the squat at 24, 48, and 72 hours post workout.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bryce Peterson
- Phone Number: 40666975460
- Email: brycepeterson@montana.edu
Study Contact Backup
- Name: Adrianna Yeats
- Phone Number: 3864516656
- Email: adriannayeats@montana.edu
Study Locations
-
-
Montana
-
Bozeman, Montana, United States, 59715
- Recruiting
- Montana State University
-
Contact:
- Mary P Miles
- Phone Number: 406-994-6678
- Email: mmiles@montana.edu
-
Contact:
- Bryce Peterson
- Phone Number: 4066975460
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 2+ years of barbell squat experience
- Currently squatting at least once a week
Exclusion Criteria:
- BMI <18 or > 40 kg/m^2
- potential allergy to Haskap or placebo ingredients
- anti-inflammatory, weight loss, anabolic steroids, testosterone, or other drugs that may interfere with the measures of the study or any other medications that may interfere with study measures
- pregnant or lactating woman
- diagnosis with type 1 or type 2 diabetes, hypo-/hyperthyroidism or any other condition that may interfere with study measures
- smoke cigarettes
- lower extremity injury within the last year
- currently following a special diet including vegan, vegetarian, low carbohydrate, or ketogenic.
- currently consuming any of the following products: tart cherry juice, pomegranate juice, or 1 or more cups of acai or other berries per day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo Control
The placebo supplement will have no polyphenol content and will be carbohydrate-matched to the experimental group.
A twice daily dose (10-12 hours apart) will be consumed for 11 days.
|
A smoothie with no polyphenolic content and matched in carbohydrate composition to the experimental haskap smoothie
|
|
Experimental: Haskap
The haskap supplement will consist of a haskap berry smoothie.
A twice daily dose (10-12) hours apart will be consumed for 11 days.
|
A smoothie blend of berries and water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Force Production
Time Frame: 72 hours
|
Maximal Voluntary Contraction (MVC) to assess force production of knee extensors at 60 degrees.
|
72 hours
|
|
Barbell Velocity
Time Frame: 72 hours
|
Barbell velocity will be measure to determine how squat velocity recovers over the course of the study.
|
72 hours
|
|
Vertical Jump
Time Frame: 72 hours
|
Force plates will be used to evaluate vertical jump height.
|
72 hours
|
|
Inflammation (pg/mL)
Time Frame: 11 days
|
Serum interleukin (IL) IL-6, IL-10, IL-1ra, tumor necrosis factor alpha (TNF-alpha),
|
11 days
|
|
Lipid peroxidation
Time Frame: 11 days
|
Plasma Malondialdehyde (MDA)
|
11 days
|
|
Creatine Kinase
Time Frame: 11 days
|
Plasma
|
11 days
|
|
C-Reactive Protein
Time Frame: 11 days
|
Plasma
|
11 days
|
|
Protein Carbonyls
Time Frame: 11 days
|
Plasma
|
11 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute Diet
Time Frame: 9 days
|
24-hour dietary recall using the Automated Self-Administered 24-hour Dietary.
Assessment Tool (ASA24).
Outcome is macronutrient and micronutrient composition of food entry.
|
9 days
|
|
Soreness
Time Frame: 72 hours
|
Soreness will be evaluated objectively by participants drawing a line on a scale of 0-10 of how sore their legs are.
0 represents no soreness at all and 10 represents the most muscular soreness the participant has felt.
A lower number could indicate less inflammation and muscular damage.
|
72 hours
|
|
Sleep Questionnaire
Time Frame: 11 days
|
Participants report information on the previous night's sleep.
What time they went to sleep, how long it took them to fall asleep, how many hours they slept, whether these were normal sleep and wake times and how restful they perceive their sleep to be on a scale of 1 to 10. 1 indicates their sleep was not restful at all and 10 indicates their sleep was as restful as possible.
|
11 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary P Miles, Montana State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-2138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammation
-
University of EdinburghUmeå UniversityCompletedSystemic Inflammation | Respiratory InflammationSweden
-
University of AarhusAarhus University Hospital; University of CopenhagenCompletedSystemic Inflammation | Airway InflammationDenmark
-
Sykehuset TelemarkRikshospitalet University Hospital; Helse Sor-OstCompletedAirway Inflammation | Peripheral Blood Inflammation Markers | Cement Dust ExposureNorway
-
Center for Research and Innovation Viña Concha...Universidad Católica del MauleNot yet recruitingInflammaging | Antioxidant Status, Inflammation | Inflammation Biomarkers | Antioxidant Capabilities | Cardiometabolic Health IndicatorsChile
-
University of NebraskaNot yet recruiting
-
Laboratorios Sophia S.A de C.V.CompletedOcular Inflammation | Ocular Pain | Pterygium | Post-surgical InflammationMexico
-
Central Hospital, Nancy, FranceRecruiting
-
Oral Science International Inc.AdvarraNot yet recruiting
-
University of NebraskaCompletedPeriodontal InflammationUnited States
-
University of California, DavisCompleted
Clinical Trials on Haskap berry smoothie
-
Montana State UniversityMontana State Agricultural Experiment StationRecruitingInflammation | Microbial Colonization | Metabolic DiseaseUnited States
-
University of ManitobaActive, not recruitingHypertension | AlertnessCanada
-
University of ReadingHaskapa LtdRecruitingCognitionUnited Kingdom
-
Montana State UniversityActive, not recruitingMicrobial Colonization | Metabolic Disease | DigestionUnited States
-
University of ManitobaCompletedInsulin | Appetite | Faba Bean | Post-prandial Blood Glucose | Satiety HormonesCanada
-
University of Alabama at BirminghamActive, not recruiting
-
St Mary's University CollegeCompletedPost-prandial GlycaemiaUnited Kingdom
-
Children's Hospital Medical Center, CincinnatiPennington Biomedical Research CenterCompletedObesityUnited States
-
University of Tennessee Graduate School of MedicineRecruitingOvary CancerUnited States
-
Northumbria UniversityThe New Zealand Institute for Plant and Food ResearchCompletedAgeingUnited Kingdom