NCT05428540

Brief Summary

This parallel, double-blind, randomised controlled trial aims to assess the effect of a polyphenol-rich dietary supplement on obesity parameters, in combination with a hypocaloric diet, for adults with morbid obesity, bariatric surgery candidates. Participants (n=40) will be randomly assigned to intervention group (IG) or control group (CG). Together with a regular hypocaloric diet (1,200 kcal/d), the IG will be given the supplement and the CG will be given a placebo. Both groups will take three capsules a day (400 mg per capsule, a total of 1,200 mg), distributed in three daily intakes (with meals). After 12 weeks and 3 visits (baseline visit, week 6 and week 12), pre and post intervention data and intervention versus placebo data will be analysed. Anthropometric and health parameters, dietary habits, lifestyle characteristics and physical activity will be assessed, and blood and urine samples will be collected in all three visits. Faecal samples will be collected at baseline and visit 3. Results will provide evidence on the effects of a combination of polyphenols on several well-established obesity parameters and will unravel possible underlying mechanisms by metabolomic analyses and microbiota diversity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

June 10, 2022

Last Update Submit

August 8, 2023

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (3)

  • Body weight

    Unit: Kilograms Measured with:bioimpedance scan

    Visit 1 (baseline)

  • Body weight

    Unit: Kilograms Measured with:bioimpedance scan

    Visit 2 (week 6)

  • Body weight

    Unit: Kilograms Measured with:bioimpedance scan

    Visit 3 (week 12)

Secondary Outcomes (90)

  • Systolic blood pressure

    Visit 1 (baseline)

  • Diastolic blood pressure

    Visit 1 (baseline)

  • Systolic blood pressure

    Visit 2 (week 6)

  • Diastolic blood pressure

    Visit 2 (week 6)

  • Systolic blood pressure

    Visit 3 (week 12)

  • +85 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Polyphenol-rich dietary supplement (3 capsules/day) + hypocaloric diet (1,200 kcal/day)

Dietary Supplement: Polyphenol-rich supplement

Control group

PLACEBO COMPARATOR

Placebo (3 capsules/day) + hypocaloric diet (1,200 kcal/day)

Other: Placebo

Interventions

Polyphenol-rich supplementDIETARY_SUPPLEMENT

Polyphenol-rich capsules containing 1,200 mg of a combination of plant extracts rich in polyphenols. Frequency: 3 capsules a day. Duration: 12 weeks.

Intervention group
PlaceboOTHER

Placebo

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 18 years old
  • Presenting morbid obesity defined as BMI ≥ 40 kg/m2
  • Referred to the Endocrinology and Nutrition Unit from Bellvitge University Hospital for a weight loss treatment

You may not qualify if:

  • History of type I diabetes
  • Endocrine disorders-derived obesity
  • Acute metabolic complications
  • History of hepatopathy or alteration of hepatic function
  • Recent history of neoplasia (\< 5 years) except for skin cancer or melanoma
  • Alcoholism, drug addiction or major psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 23, 2022

Study Start

August 8, 2022

Primary Completion

June 16, 2023

Study Completion

June 16, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

ES(1)