Effect of Strawberry Consumption on the Microbiome
|ClinicalTrials.gov Identifier: NCT04217122|
Recruitment Status : Completed
First Posted : January 3, 2020
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Microbiome||Other: strawberry powder Other: placebo powder||Not Applicable|
This will be a randomized, double-blinded, placebo controlled, parallel design. Thirty subjects will be randomized to consume two servings of standardized freeze-dried strawberry powder (2 x 13g) daily or placebo for 4 weeks, followed by 2 weeks of follow up with beige diet only to observe whether the effect can be sustained for 2 weeks. Blood will be collected at baseline (week 0), weeks 4 and week 6 after strawberry consumption. On the day prior to the study visits participants will collect a stool and a 24-hr urine sample and bring to the lab. In addition, body weight and composition will be determined and questionnaires and 3-day food record will be completed. Twenty-four hour urine content of pelargonidin glucuronide will be measured for compliance. Plasma and fecal cholesterol and bile acids will be determined at baseline (week 0) and weeks 4 and 6.
Subjects will be assigned an enrollment number after signing the informed consent form approved by the UCLA Medical Internal Review Board. Subjects will undergo a physical exam, complete medical history, and blood draw. A standard chem. panel will be performed at the UCLA clinical laboratory. Eligible subjects will be enrolled into the study upon completion of screening evaluations and will be randomized to the strawberry or placebo arm at their baseline visit.
The study will be conducted in healthy free-living subjects (18-55 years). Subjects consume 13 grams standard strawberry powder in the morning and afternoon/evening or placebo powder for 4 weeks. Subjects will be instructed to eat a beige diet (low fiber<10g and low polyphenols <3 servings of polyphenol rich fruit/vegetables per day) during the entire study period. 24 hr urine pelargonidin glucuronide will be measured at weeks 2 (baseline), 6 and 8 for compliance. In addition, pelargondin, ellagic acid, dimethylellagic acid glucuronide and urolithin glucuronide will be measured in plasma and urine to determine strawberry phytochemical bioavailability and intestinal/microbiome metabolic capacity. Participants will meet with the dietitian for assessment of habitual dietary pattern and instructions on maintain on a beige diet. A list of foods with high fiber and phenolic compounds will be provided and subjects are instructed to follow the diet during the entirety of the study.
A standardized freeze-dried strawberry powder and a strawberry placebo powder provided by the California Strawberry Commission will be used. Ten grams of freeze dried powder is equivalent to about 110 g fresh fruit. One serving of fresh strawberry (one cup) is estimated to weigh 144 g and therefore is equivalent to 13 g of freeze dried powder. Subjects will consume two packages of 13 g of strawberry powder per day. The powder can be mixed into beverages and consumed with breakfast and dinner.
Strawberry powder ingredients include Individually Quick Frozen (IQF) strawberries. Placebo powder ingredients include fructose, sucrose, dextrose, tapioca maltodextrin, modified food starch, erythritol, cellulose gum, citric acid (anhydrous), N-C Strawberry Flavor Natual WONF, xanthan gum, malic acid, sugar beet fiber, silicon dioxide, nat. strawberry-type flavor, FD&C Red #40, FD&C Yellow 6, FD&C Blue 2.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Strawberry Consumption on the Microbiome in Healthy Subjects: A Pilot Study|
|Actual Study Start Date :||September 11, 2018|
|Actual Primary Completion Date :||February 21, 2019|
|Actual Study Completion Date :||December 19, 2019|
Experimental: Strawberry intervention group
Participants consume two packages of 13 g of standard strawberry powder in the morning and afternoon/evening per day for 4 weeks
Other: strawberry powder
Participants consume 2 packages of standard strawberry powder (13 g x 2) daily for 4 weeks
Placebo Comparator: Placebo group
Participants consume two packages of 13 grams placebo powder in the morning and afternoon/evening for 4 weeks.
Other: placebo powder
Participants consume 2 packages of placebo powder (13 g x 2) daily for 4 weeks
- Change in microbiome composition [ Time Frame: 4 weeks ]Change in phyla, genes and species of gut bacteria
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217122
|United States, California|
|UCLA Center for Human Nutrition, 1000 Veteran Ave.|
|Los Angeles, California, United States, 90095|