Influence of a Polyphenol-rich Supplement on Anthropometric, Biochemical and Inflammatory Parameters in Participants With Morbid Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Body weight
Study Overview
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.
Detailed Description
The main objective of this study is to assess the effect of a polyphenol-rich dietary supplement, along with a hypocaloric diet, on obesity parameters in participants with morbid obesity. Anthropometric, biochemical and inflammatory parameters, as well as different metabolic pathways and microbiota diversity will be assessed.
The estimated number of participants to include is 40. They will be patients with morbid obesity, referred to the Endocrinology and Nutrition Unit from Bellvitge University Hospital for a weight loss treatment, in many cases prior to a bariatric surgery. To estimate the sample size the following assumptions were made: same number of participants in each group; 10% variation in anthropometric and laboratory measurements; trial power of 0.85 and alfa error of 5%; estimated losses to follow-up: 15%.
The main component of the intervention is a polyphenol-rich dietary supplement administrated for 12 weeks. Lifestyle, dietary, physical activity data and blood and urine samples will be collected in three visits (baseline, week 6 and week 12); faecal samples will be collected in visits baseline and week 12. All participants will follow a hypocaloric diet and will be randomly assigned to either intervention group (IG) or control group (CG) after recruitment, following a simple randomisation procedure. The IG will take the supplement (3 capsules/day), whereas the CG will take a placebo (3 capsules/day).
This trial will be carried out following the ethical guidelines of the Declaration of Helsinki, the Principles of the Good Clinical Practice, under the existing legislation. Data collected will be kept strictly confidential. Any participant will have the right to access, rectification, cancellation and opposition over such data in accordance with the Organic Law 15/1999, Personal Data Protection. All information will be stored in a Data Collection Notebook, from which the database will be created.
All participants will be provided with an information sheet and will have to sign a consent form before the beginning of this trial. Any participant will be allowed to abandon the study for any reason: if requested; if the suspension is in the medical interest; if an incidence is presented as a consequence of the intervention, inacceptable or representing a threat to the participants' health; if the participant presents any breakthrough disease or other condition that, according to the principal investigator (PI), are relevant to suspend the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •History of type I diabetes
- •Endocrine disorders-derived obesity
- •Acute metabolic complications
- •Severe inflammatory process that might affect the inflammatory condition during the 4 weeks before inclusion
- •Cardiovascular event during the 6 months before inclusion
- •History of hepatopathy or alteration of hepatic function
- •Pregnant, lactation period or willing to get pregnant in the 12 weeks after inclusion
- •Recent history of neoplasia (< 5 years) except for skin cancer or melanoma
- •Oral or IV line glucocorticoids during 14 consecutive days or more 3 months before inclusion
- •Alcoholism, drug addiction or major psychiatric disorder
Arms & Interventions
Intervention group
Polyphenol-rich dietary supplement (3 capsules/day) + hypocaloric diet (1,200 kcal/day)
Intervention: Polyphenol-rich supplement (Dietary Supplement)
Control group
Placebo (3 capsules/day) + hypocaloric diet (1,200 kcal/day)
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Body weight
Time Frame: Visit 3 (week 12)
Unit: Kilograms Measured with:bioimpedance scan
Body weight
Time Frame: Visit 1 (baseline)
Unit: Kilograms Measured with:bioimpedance scan
Body weight
Time Frame: Visit 2 (week 6)
Unit: Kilograms Measured with:bioimpedance scan
Secondary Outcomes
- Thyroid-stimulating hormone (TSH)(Visit 3 (week 12))
- Thyroxine(Visit 3 (week 12))
- Insulin(Visit 3 (week 12))
- LDL (low-density lipoprotein)-cholesterol(Visit 3 (week 12))
- Hemoglobin(Visit 3 (week 12))
- Interleukin-6(Visit 3 (week 12))
- high sensitivity c-reactive protein(Visit 3 (week 12))
- Creatinin(Visit 3 (week 12))
- Diastolic blood pressure(Visit 3 (week 12))
- Alanine aminotransferase(Visit 3 (week 12))
- Glucose(Visit 3 (week 12))
- Systolic blood pressure(Visit 3 (week 12))
- Urea(Visit 3 (week 12))
- Leucocytes(Visit 3 (week 12))
- Dietary intake(Visit 3 (week 12))
- Total cholesterol(Visit 3 (week 12))
- Aspartate aminotransferase(Visit 3 (week 12))
- Triglycerides(Visit 3 (week 12))
- Physical activity level(Visit 3 (week 12))
- Bilirrubin(Visit 3 (week 12))
- Erithrocytes(Visit 3 (week 12))
- HDL (high-density lipoprotein)-cholesterol(Visit 3 (week 12))
- Adiponectin(Visit 3 (week 12))
- Hip circumference(Visit 3 (week 12))
- Glycosylated hemoglobin(Visit 3 (week 12))
- TNF-alpha receptor I(Visit 3 (week 12))
- TNF-alpha receptor II(Visit 3 (week 12))
- Waist circumference(Visit 3 (week 12))
- Fat mass(Visit 3 (week 12))
- Muscle mass(Visit 3 (week 12))
- Hemoglobin(Visit 1 (baseline))
- Erithrocytes(Visit 2 (week 6))
- 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))
- Dietary intake(Visit 1 (baseline))
- Dietary intake(Visit 2 (week 6))
- Physical activity level(Visit 1 (baseline))
- Physical activity level(Visit 2 (week 6))
- Alanine aminotransferase(Visit 1 (baseline))
- Alanine aminotransferase(Visit 2 (week 6))
- Aspartate aminotransferase(Visit 1 (baseline))
- Aspartate aminotransferase(Visit 2 (week 6))
- Bilirrubin(Visit 1 (baseline))
- Bilirrubin(Visit 2 (week 6))
- Thyroid-stimulating hormone (TSH)(Visit 1 (baseline))
- Thyroid-stimulating hormone (TSH)(Visit 2 (week 6))
- Thyroxine(Visit 1 (baseline))
- Thyroxine(Visit 2 (week 6))
- Creatinin(Visit 1 (baseline))
- Creatinin(Visit 2 (week 6))
- Urea(Visit 1 (baseline))
- Urea(Visit 2 (week 6))
- Erithrocytes(Visit 1 (baseline))
- Hemoglobin(Visit 2 (week 6))
- Leucocytes(Visit 1 (baseline))
- Leucocytes(Visit 2 (week 6))
- Total cholesterol(Visit 1 (baseline))
- Total cholesterol(Visit 2 (week 6))
- LDL (low-density lipoprotein)-cholesterol(Visit 1 (baseline))
- LDL (low-density lipoprotein)-cholesterol(Visit 2 (week 6))
- HDL (high-density lipoprotein)-cholesterol(Visit 1 (baseline))
- HDL (high-density lipoprotein)-cholesterol(Visit 2 (week 6))
- Triglycerides(Visit 1 (baseline))
- Triglycerides(Visit 2 (week 6))
- Glucose(Visit 1 (baseline))
- Glucose(Visit 2 (week 6))
- Glycosylated hemoglobin(Visit 1 (baseline))
- Glycosylated hemoglobin(Visit 2 (week 6))
- Insulin(Visit 1 (baseline))
- Insulin(Visit 2 (week 6))
- TNF-alpha receptor I(Visit 1 (baseline))
- TNF-alpha receptor I(Visit 2 (week 6))
- TNF-alpha receptor II(Visit 1 (baseline))
- TNF-alpha receptor II(Visit 2 (week 6))
- Interleukin-6(Visit 1 (baseline))
- Interleukin-6(Visit 2 (week 6))
- Adiponectin(Visit 1 (baseline))
- Adiponectin(Visit 2 (week 6))
- high sensitivity c-reactive protein(Visit 1 (baseline))
- high sensitivity c-reactive protein(Visit 2 (week 6))
- Waist circumference(Visit 1 (baseline))
- Waist circumference(Visit 2 (week 6))
- Hip circumference(Visit 1 (baseline))
- Hip circumference(Visit 2 (week 6))
- Fat mass(Visit 1 (baseline))
- Fat mass(Visit 2 (week 6))
- Muscle mass(Visit 1 (baseline))
- Muscle mass(Visit 2 (week 6))
Investigators
Raul Zamora Ros
Principal Investigator
Institut d'Investigació Biomèdica de Bellvitge