Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity (OBHEALTH)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2019-12-14

Brief Summary

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The study aimed at assessing the effect of a decaffeinated green coffee extract, rich in hydroxycinnamates, oat beta-glucans or the combination of both bioactive compounds on overweight/obese subjects with hyperglycemia.

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Detailed Description

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In a randomized, crossover, blind, three-arm study, volunteers consumed twice a day a nutraceutical providing 5 g/d beta-glucan (BG), 600 mg/d green coffee polyphenols (GC) or a combination of both (5 g/d BG + 600 mg/d GC). Each intervention stage lasted 8 weeks and was followed by a 4-week wash-out.

Blood, urine and fecal samples were obtained at the beginning and end of each intervention stage. Blood pressure, oral glucose tolerance test (OGTT) and body composition (body weight, anthropometry, bioimpedance) were measured at each control visit. Physical activity was controlled by accelerometry (1 week during each intervention stage). Energy expenditure was measured by calorimetry. Food intake was monitored by 3-d food records. Satiety was determined by subjective (VAS) and objective (weighting consumed food) records after consuming the nutraceutical during each intervention stage.

In a subset of volunteers (9), a pharmacokinetic study was performed to assess bioavailability and metabolism of polyphenols at the beginning and end of each intervention (GC and GC+BG only). In these volunteers, blood was taken at different times during 24 h; urine samples were also collected at different intervals during 24 h, and feces were obtained at 0 and 24 h approximately after consuming the nutraceuticals containing GC. A targeted metabolomic analysis was carried out in these samples. In these volunteers, incretins and hormones were also determined in blood samples.

Conditions

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Overweight/Obesity Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

After a run-in period, participants were randomly allocated to one of each arm. Each intervention stage (8 weeks) was separated by a 4-week wash-out.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Nutraceutical was provided in aluminum foil sachets marked A, B or C for blinding to participants. Aroma and flavor compounds were added to ensure similar organoleptic properties of the 3 nutraceuticals tested.

Study Groups

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Green coffee extract

Nutraceutical containing a decaffeinated green coffee extract rich in phenolic compounds (hydroxycinnamates). Participants received powdered sachets containing 300 mg of GC extract twice daily for 8 weeks

Group Type EXPERIMENTAL