Obese, Overweight
Conditions
Brief summary
Pilot study to determine whether daily consumption of blackraspberry powder (high in polyphenols) can reduce markers of inflammation and to determine whether genetics influence baseline levels of inflammatory markers as well as individual's response to polyphenols. A total of 10 males participated in this cross-over study.
Detailed description
A high-fat, high-calorie challenge meal is administered to induce an inflammatory response in overweight and obese adult males. Serum levels of CRP, TNF-alpha, and IL-6 are measured prior to the challenge meal and at various times (1,2,4,8, and 12 hours) after the challenge meal. The challenge meal is given once without intervention and once after 5 daily doses of concentrated black-raspberry powder mixed in water.
Interventions
DIETARY_SUPPLEMENTBlackraspberry Slurry
Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries.
Sponsors
Medical College of Wisconsin
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adult males over 55 years of age * overweight or obese
Exclusion criteria
* history of adverse reaction to berries or berry products * history of adverse reaction to high-fat, high-calorie challenge meal * significant liver or renal insufficiency * significant cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum IL-6 | acute (0-12 hours) after inflammation-causing challenge meal | Area Under the time-concentration Curve (AUC) of IL-6 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Black-raspberry Powder Black-raspberry powder: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries | 5 |
| No Intervention Water without lypholized black raspberry powder | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Black-raspberry Powder | Total | No Intervention |
|---|---|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 6.9 | 64.7 years STANDARD_DEVIATION 6.9 | 64.7 years STANDARD_DEVIATION 6.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 5 Participants |
| Region of Enrollment United States | 5 participants | 10 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Serum IL-6
Area Under the time-concentration Curve (AUC) of IL-6
Time frame: acute (0-12 hours) after inflammation-causing challenge meal
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Water | Serum IL-6 | 42.4 (pg*hr)/mL |
| Blackraspberry Slurry | Serum IL-6 | 34.3 (pg*hr)/mL |