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Impacts of Wild Blueberries on Appetite and Weight Regulation

Primary Purpose

Obesity, Weight Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blueberries
Placebo
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Blueberries, Yogurt, Weight loss, Appetite

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Arm Label

    Blueberries-Phase I

    Syrup-Phase I

    Blueberries-Phase II

    Syrup-Phase II

    Arm Description

    feeding will consist of 1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal)

    feeding will consist of an isocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani)

    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

    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

    Outcomes

    Primary Outcome Measures

    Plasma Glucose
    fasted
    Total Cholesterol
    Triglycerides
    HDL-Cholesterol
    Insulin
    Ghrelin
    Pancreatic peptide
    C-Reactive Protein
    Total Antioxidant Capacity
    Colorimetric assay kit using blood serum
    Blood Pressure
    Systolic and Diastolic
    Body Composition
    Daily via bioimpedance Wifi Scales
    Body Composition
    dual x-ray absorptiometry

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2023
    Last Updated
    February 17, 2023
    Sponsor
    San Diego State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05736432
    Brief Title
    Impacts of Wild Blueberries on Appetite and Weight Regulation
    Official Title
    Impacts of Wild Blueberries on Appetite and Weight Regulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    February 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    San Diego State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective is to complete a two-phase study to assess how wild blueberries impact regulation of appetite of overweight and obese men and women as well as to determine if wild blueberries can promote more effective weight loss than an isocaloric control. For phase I, the acute effects of consuming 1-cup of frozen wild blueberries mixed into ¾ C of low-fat yogurt will be compared to consuming an isocaloric serving of yogurt mixed with an artificially flavored and colored blueberry syrup. During acute testing, subjective ratings of appetite, glucose metabolism, and appetite-regulating hormones will be assessed. Phase II will consist of an 8-week feeding trial in which the same subjects will consume daily servings of yogurt mixed with either frozen wild blueberries or placebo syrup along with intensive counseling for weight loss. The hypothesis is that wild blueberries will reduce hunger by regulating appetite hormones and promoting beneficial glycemic and insulinemic responses and that daily consumption of wild blueberries will translate to improved adherence to a weight loss regimen and therefore greater weight and fat loss. Secondary aims for Phase II of this project will include exploring the impacts of blueberry consumption during weight loss on antioxidant status, inflammatory markers, blood lipid profiles, glucose status, dietary intake, physical activity and blood pressure.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Weight Loss
    Keywords
    Blueberries, Yogurt, Weight loss, Appetite

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Blueberries-Phase I
    Arm Type
    Experimental
    Arm Description
    feeding will consist of 1 C frozen wild blueberries along with ¾ C low-fat Mountain High yogurt (total energy intake=170 kcal)
    Arm Title
    Syrup-Phase I
    Arm Type
    Placebo Comparator
    Arm Description
    feeding will consist of an isocaloric feeding of ¾ C yogurt mixed with artificially flavored and colored blueberry syrup (Torani)
    Arm Title
    Blueberries-Phase II
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Syrup-Phase II
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Blueberries
    Intervention Description
    Experimental condition
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo condition
    Primary Outcome Measure Information:
    Title
    Plasma Glucose
    Description
    fasted
    Time Frame
    8 weeks
    Title
    Total Cholesterol
    Time Frame
    8 weeks
    Title
    Triglycerides
    Time Frame
    8 weeks
    Title
    HDL-Cholesterol
    Time Frame
    8 weeks
    Title
    Insulin
    Time Frame
    8 weeks
    Title
    Ghrelin
    Time Frame
    8 weeks
    Title
    Pancreatic peptide
    Time Frame
    8 weeks
    Title
    C-Reactive Protein
    Time Frame
    8 weeks
    Title
    Total Antioxidant Capacity
    Description
    Colorimetric assay kit using blood serum
    Time Frame
    8 weeks
    Title
    Blood Pressure
    Description
    Systolic and Diastolic
    Time Frame
    8 weeks
    Title
    Body Composition
    Description
    Daily via bioimpedance Wifi Scales
    Time Frame
    8 weeks
    Title
    Body Composition
    Description
    dual x-ray absorptiometry
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mark Kern, PhD
    Phone
    ‭(619) 889-8954‬
    Email
    kern@sdsu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shirin Hooshmand, PhD
    Phone
    ‭(512) 826-0678‬
    Email
    shooshmand@sdsu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30669469
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26162950
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19515743
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25611327
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25372283
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23220243
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21861718
    Citation
    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.
    Results Reference
    background

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    Impacts of Wild Blueberries on Appetite and Weight Regulation

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