NCT05736432

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

February 9, 2023

Last Update Submit

February 19, 2025

Conditions

Keywords

BlueberriesYogurtWeight lossAppetite

Outcome Measures

Primary Outcomes (12)

  • Plasma Glucose

    fasted

    8 weeks

  • Total Cholesterol

    Total Cholesterol

    8 weeks

  • Triglycerides

    Triglycerides

    8 weeks

  • HDL-Cholesterol

    HDL-Cholesterol

    8 weeks

  • Insulin

    Insulin

    8 weeks

  • Ghrelin

    Ghrelin

    8 weeks

  • Pancreatic peptide

    Pancreatic peptide

    8 weeks

  • C-Reactive Protein

    C-Reactive Protein

    8 weeks

  • Total Antioxidant Capacity

    Colorimetric assay kit using blood serum

    8 weeks

  • Blood Pressure

    Systolic and Diastolic

    8 weeks

  • Body Composition

    Daily via bioimpedance Wifi Scales

    8 weeks

  • Body Composition

    dual x-ray absorptiometry

    8 weeks

Study Arms (4)

Blueberries-Phase I

EXPERIMENTAL

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

Dietary Supplement: Blueberries

Syrup-Phase I

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Blueberries-Phase II

EXPERIMENTAL

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

Dietary Supplement: Blueberries

Syrup-Phase II

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

BlueberriesDIETARY_SUPPLEMENT

Experimental condition

Blueberries-Phase IBlueberries-Phase II
PlaceboDIETARY_SUPPLEMENT

Placebo condition

Syrup-Phase ISyrup-Phase II

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Overweight or Obese (BMI 25-40)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mark Kern, PhD, RD

San Diego, California, 92182-7251, United States

Location

Related Publications (8)

  • 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.

    PMID: 30669469BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26162950BACKGROUND
  • 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.

    PMID: 19515743BACKGROUND
  • 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.

    PMID: 25611327BACKGROUND
  • 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.

    PMID: 25372283BACKGROUND
  • 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.

    PMID: 23220243BACKGROUND
  • 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.

    PMID: 21861718BACKGROUND

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

blueberry extract

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Shirin Hooshmand, PhD, RD

    San Diego State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

March 1, 2023

Primary Completion

November 1, 2024

Study Completion

February 1, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations