- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05736432
Impacts of Wild Blueberries on Appetite and Weight Regulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For Phase I, all subjects will complete two acute feeding trials in random order. One feeding will consist of 1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal). The other feeding will consist of an isocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani). A standardized meal will be consumed the evening prior to testing to minimize fluctuations during the testing days. Arterialized fingerprick blood samples from heated hands will be collected into Greiner Bio-One MiniCollect™ Capillary Blood Collection System Tubes containing Ethylenediaminetetraacetic acid while fasted and 30, 60 and 120 minutes after food intake for analysis of glucose, insulin, ghrelin, and pancreatic peptide. Appetitive responses (hunger, fullness, desire to eat, and prospective food consumption) will be assessed by 100-mm visual analog scales at baseline and 15, 30, 45, 60, 90, and 120 minutes after intake.
For Phase II, subjects will be equally divided and matched for body fatness into two randomly assigned groups. Both groups will be counseled for weight loss, which will be achieved through a comprehensive program including a) dietary intervention, b) daily text messaging, and c) daily at-home weighing with a WiFi-enabled scale. In addition, groups will be randomly assigned to daily consume the same 170 kcal yogurt parfait described above containing either wild blueberries or placebo as an afternoon snack for 8 weeks. The rationale for the inclusion of a healthy, wild blueberry in yogurt afternoon snack intervention is supported by the National Health And Nutrition Examination Survey analyses that revealed a shift in eating patterns towards the evening in combination with an increase in snacking occasions, particularly in the afternoon/evening hours. Further, the majority of the snacking occasions include unhealthy, high fat/high sugar foods, potentially contributing to unwanted weight gain and obesity. Moreover, since blueberries can elevate pancreatic peptide for at least 2 hours after consumption, this could enhance the likelihood of maintaining lower intake during the evening meal. Thus, overall, it is proposed that the afternoon wild blueberry/yogurt snack will promote satiety and reduce overeating (especially of unhealthy foods) later in the day.
All participants will be counseled to achieve a 500-kcal/d energy deficit (from their baseline eucaloric diet). Energy requirements will be estimated by calculating resting metabolic rate using the equations of Schofield and multiplying by an activity factor of 1.3. The participants will meet with investigators every two-weeks for intensive counseling to ensure adherence to the dietary prescription. Before and after the trial, fasted blood will be collected into tubes for both plasma and serum to assess total antioxidant capacity, C-reactive protein, blood lipid concentrations, glucose and insulin. During lab visits investigators will assess anthropometrics (height, body weight, and body composition via dual x-ray absorptiometry, dietary intake, physical activity behaviors, food cravings, and blood pressure. Adequate samples of blood will be collected to allow us to bank plasma for future analyses if additional funding is obtained in the future.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mark Kern, PhD
- Phone Number: (619) 889-8954
- Email: kern@sdsu.edu
Study Contact Backup
- Name: Shirin Hooshmand, PhD
- Phone Number: (512) 826-0678
- Email: shooshmand@sdsu.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92182-7251
- Mark Kern, PhD, RD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Overweight or Obese (BMI 25-40)
Exclusion Criteria:
- Pregnancy
- Smoking
- >5 kg wt fluctuation in the past 3 months
- exercising > 2 times per week
- Medical conditions or medications that may affect body weight, metabolism, other outcome measures
- Allergy to blueberries or yogurt
- Already eating blueberries more than twice weekly
- Consumption of >50 g/d alcohol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Blueberries-Phase I
feeding will consist of 1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal)
|
Experimental condition
|
Placebo Comparator: Syrup-Phase I
feeding will consist of an isocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani)
|
Placebo condition
|
Experimental: Blueberries-Phase II
1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal) along with a) dietary intervention, b) daily text messaging, and c) daily at-home weighing with a WiFi-enabled scale
|
Experimental condition
|
Placebo Comparator: Syrup-Phase II
isocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani) along with a) dietary intervention, b) daily text messaging, and c) daily at-home weighing with a WiFi-enabled scale
|
Placebo condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Glucose
Time Frame: 8 weeks
|
fasted
|
8 weeks
|
Total Antioxidant Capacity
Time Frame: 8 weeks
|
Colorimetric assay kit using blood serum
|
8 weeks
|
Blood Pressure
Time Frame: 8 weeks
|
Systolic and Diastolic
|
8 weeks
|
Body Composition
Time Frame: 8 weeks
|
Daily via bioimpedance Wifi Scales
|
8 weeks
|
Body Composition
Time Frame: 8 weeks
|
dual x-ray absorptiometry
|
8 weeks
|
Total Cholesterol
Time Frame: 8 weeks
|
Total Cholesterol
|
8 weeks
|
Triglycerides
Time Frame: 8 weeks
|
Triglycerides
|
8 weeks
|
HDL-Cholesterol
Time Frame: 8 weeks
|
HDL-Cholesterol
|
8 weeks
|
Insulin
Time Frame: 8 weeks
|
Insulin
|
8 weeks
|
Ghrelin
Time Frame: 8 weeks
|
Ghrelin
|
8 weeks
|
Pancreatic peptide
Time Frame: 8 weeks
|
Pancreatic peptide
|
8 weeks
|
C-Reactive Protein
Time Frame: 8 weeks
|
C-Reactive Protein
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Shirin Hooshmand, PhD, RD, San Diego State University
Publications and helpful links
General Publications
- DeFuria J, Bennett G, Strissel KJ, Perfield JW 2nd, Milbury PE, Greenberg AS, Obin MS. Dietary blueberry attenuates whole-body insulin resistance in high fat-fed mice by reducing adipocyte death and its inflammatory sequelae. J Nutr. 2009 Aug;139(8):1510-6. doi: 10.3945/jn.109.105155. Epub 2009 Jun 10.
- Stote K, Corkum A, Sweeney M, Shakerley N, Kean T, Gottschall-Pass K. Postprandial Effects of Blueberry (Vaccinium angustifolium) Consumption on Glucose Metabolism, Gastrointestinal Hormone Response, and Perceived Appetite in Healthy Adults: A Randomized, Placebo-Controlled Crossover Trial. Nutrients. 2019 Jan 19;11(1):202. doi: 10.3390/nu11010202.
- Molan AL, Lila MA, Mawson J. Satiety in rats following blueberry extract consumption induced by appetite-suppressing mechanisms unrelated to in vitro or in vivo antioxidant capacity. Food Chemistry. 2008 Apr 1;107(3):1039-44.
- James LJ, Funnell MP, Milner S. An afternoon snack of berries reduces subsequent energy intake compared to an isoenergetic confectionary snack. Appetite. 2015 Dec;95:132-7. doi: 10.1016/j.appet.2015.07.005. Epub 2015 Jul 7.
- Elks CM, Terrebonne JD, Ingram DK, Stephens JM. Blueberries improve glucose tolerance without altering body composition in obese postmenopausal mice. Obesity (Silver Spring). 2015 Mar;23(3):573-80. doi: 10.1002/oby.20926. Epub 2015 Jan 22.
- Nair AR, Elks CM, Vila J, Del Piero F, Paulsen DB, Francis J. A blueberry-enriched diet improves renal function and reduces oxidative stress in metabolic syndrome animals: potential mechanism of TLR4-MAPK signaling pathway. PLoS One. 2014 Nov 5;9(11):e111976. doi: 10.1371/journal.pone.0111976. eCollection 2014.
- Roopchand DE, Kuhn P, Rojo LE, Lila MA, Raskin I. Blueberry polyphenol-enriched soybean flour reduces hyperglycemia, body weight gain and serum cholesterol in mice. Pharmacol Res. 2013 Feb;68(1):59-67. doi: 10.1016/j.phrs.2012.11.008. Epub 2012 Dec 4.
- Seymour EM, Tanone II, Urcuyo-Llanes DE, Lewis SK, Kirakosyan A, Kondoleon MG, Kaufman PB, Bolling SF. Blueberry intake alters skeletal muscle and adipose tissue peroxisome proliferator-activated receptor activity and reduces insulin resistance in obese rats. J Med Food. 2011 Dec;14(12):1511-8. doi: 10.1089/jmf.2010.0292. Epub 2011 Aug 23.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-2023-001
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 Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Blueberries
-
Colorado State UniversityUnited States Department of Agriculture (USDA)Recruiting
-
University Hospital, LinkoepingCompletedInflammation | Exercise | Risk Factors Cardiovascular Disease | Sedentary LifeSweden
-
Ullevaal University HospitalUniversity of OsloUnknownMemory | Gene ExpressionNorway
-
USDA, Western Human Nutrition Research CenterU.S. Highbush Blueberry CouncilCompletedInflammationUnited States
-
Cornell UniversityCompletedSkeletal Muscle DisorderUnited States
-
University of ReadingAlpro Foundation; Wild Blueberry Association of North AmericaCompleted
-
University College CorkU.S. Highbush Blueberry CouncilRecruitingObesity | Overweight and ObesityIreland
-
Clinical Nutrition Research Center, Illinois Institute...CompletedHealthy | Overweight | ObeseUnited States
-
University of North Carolina, Chapel HillCompletedMild Cognitive DeclineUnited States
-
University of Kansas Medical CenterU.S. Highbush Blueberry CouncilRecruiting