The purpose of this 2-stage intervention study is to investigate the effect of a novel nutraceutical (containing tetrahydro iso-alpha acids derived from hops) on weight loss and weight loss maintenance in obese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
130
Functional Medicine Research Center
Gig Harbor, Washington, United States
Weight loss maintenance
The primary endpoint is the absolute pounds of weight change from baseline to the end of the 64 weeks.
Time frame: Baseline, 64 weeks
Weight loss
Percent weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2).
Time frame: Baseline, 12 weeks
Weight loss
Absolute amount of weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2).
Time frame: Baseline, 12 weeks
Short-term THIAA effect
Comparing the difference in absolute amount of weight loss between 2 arms at the end of 12 weeks (i.e. the Stage 1 of the trial).
Time frame: Baseline, 12 weeks
Short-term THIAA effect
Comparing the difference in percent weight loss between 2 arms at the end of 12 weeks (i.e. the Stage 1 of the trial).
Time frame: Baseline, 12 weeks
Weight loss
To evaluate absolute amount of weight loss during Stage 2 of the trial where subjects participate in MLGL (i.e. 12 weeks to 64 weeks).
Time frame: 12 weeks, 64 weeks
Weight loss
To evaluate percent weight loss during Stage 2 of the trial where subjects participate in MLGL (i.e. 12 weeks to 64 weeks).
Time frame: 12 weeks, 64 weeks
Long-term THIAA effect
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To evaluate the difference between 2 arms the amount of weight loss during the trial (i.e. baseline to 64 weeks).
Time frame: baseline, 64 weeks