Dietary Supplementation on Body Fat Composition

NCT06296251 | Recruiting

• 1 other identifier: BIO-2313
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo.

Conditions

Dyslipidemias; Pre-diabetes

Outcome Measures

Primary Outcomes (1)

• Body fat mass

  Body fat mass (kg) change by the DEXA scan.

  0, 12, 24 weeks

Secondary Outcomes (39)

• Body composition

  0, 12, 24 weeks

• Android fat mass

  0, 12, 24 weeks

• Gynoid fat mass

  0, 12, 24 weeks

• Abdominal visceral fat mass

  0, 12, 24 weeks

• Abdominal circumference

  0, 12, 24 weeks

Study Arms (3)

Placebo treatment

PLACEBO COMPARATOR

Placebo treatment (Microcrystaline cellulose): 1 capsule/day

Other: Placebo treatment

Active low dose of plant derived phenolics

ACTIVE COMPARATOR

Active low dose of plant derived phenolics via 1 capsule/day

Dietary Supplement: Plant derived phenolics

Active high dose of plant derived phenolics

ACTIVE COMPARATOR

Active high dose of plant derived phenolics via 1 capsule/day

Dietary Supplement: Plant derived phenolics

Interventions

Placebo treatment OTHER

Microcrystaline cellulose (MCC)

Placebo treatment

Plant derived phenolics DIETARY_SUPPLEMENT

Dietary supplement containing plant derived phenolics

Active high dose of plant derived phenolics; Active low dose of plant derived phenolics

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥18 years of age at visit 1 (week -1).
• Body mass index (BMI) of ≥28.0 kg/m2 to \<35.0 kg/m2 at visit 1 (week -1).
• At least one of the following comorbidities based on blood draws at visit 1:
• Dyslipidemia (any of the following)
• Total-C ≥200 mg/dL
• LDL-C ≥130 mg/dL
• HDL-C ≤40 mg/dL
• Triglycerides ≥150 mg/dL
• Pre-diabetes o HbA1c ≥5.7 to ≤6.4% Stable use of medications allowed, where stable use is defined as the same dose for at least 90 d prior to visit1.
• Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period.
• Willing to adhere to all study procedures and signs forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.

You may not qualify if:

• Weight loss or gain ≥4.5 kg within 90 days of visit 1.
• Use of weight loss medications within 90 days of visit 1
• History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
• Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1.
• History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
• History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
• Current medical diagnosis of type 1 or type 2 diabetes mellitus.
• HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1.
• History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
• History of liver disease with exception of non-alcoholic fatty livery disease (NAFLD).
• Unstable use of medications for mental or emotional disorders, where stable use is defined as the same dose for ≥90 days prior to visit 1.
• Uncontrolled stage 2 hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1. Participants with hypertension on a stable dose of medication may be allowed in the study per Investigator's discretion. Stable dose is defined as same dose for \>90 days.
• Habitual use (i.e., daily) of marijuana and hemp products including CBD products within 30 days of visit 1.
• History or presence of cancer (including any malignant GI polyps) within 2 years of visit 1, except for non-melanoma skin cancer.
• Unstable use of thyroid hormone replacement medication, where stable use is defined as the same dose for ≥90 days prior to visit 1.

Sponsors & Collaborators

• Brightseed: lead

Study Sites (1)

Biofortis Research

Addison, Illinois, 60101, United States

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Glucose Intolerance

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Glucose Metabolism Disorders

Central Study Contacts

Doug Bolster

CONTACT

(415) 965-7778; dbolster@brightseedbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: April 18, 2024
• Primary Completion: December 27, 2024
• Study Completion: February 27, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)