Chronic Consumption of Vinegar on Visceral Adiposity in Overweight Adults (VAnish)

NCT04706520 | Terminated

• 1 other identifier: PBRC-2020-048
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To assess, relative to a placebo, the effects of consuming 400 mL/day or 200 mL/day of a vinegar beverage providing either 1,500 mg/day of acetic acid (in two 200 mL doses daily) or 750 mg/day of acetic acid (in one 200 mL dose daily), respectively, for 12 weeks on VAT (MRI). Thus the 2 active comparator arms 400 mL and 200 mL of vinegar will be independently tested compared to placebo.

Conditions

Body Composition

Outcome Measures

Primary Outcomes (1)

• Visceral Adipose Tissue (VAT)

  The primary objective is to assess the effects of consuming vinegar (1500mg/day and 750mg/day) on visceral adipose tissue via MRI as compared to a placebo.

  12 weeks

Secondary Outcomes (2)

• Body Weight

  12 weeks

• Triglycerides

  12 weeks

Study Arms (3)

Group 1: Vinegar

EXPERIMENTAL

Participants will consume 400 mL/day vinegar beverage providing 1,500 mg/day acetic acid \[200 mL vinegar beverage, twice per day (prior to breakfast and dinner)\] for 12 weeks.

Dietary Supplement: Study Beverage Consumption

Group 2: Vinegar/Placebo Combination

EXPERIMENTAL

Participants will consume 200 mL/day vinegar beverage and 200 mL/day placebo beverage providing 1,200 mg/day lactate \[200 mL placebo beverage 1x/day\] and 750 mg/day acetic acid \[200 mL vinegar beverage 1x/day\] (prior to breakfast and dinner) for 12 weeks.

Dietary Supplement: Study Beverage Consumption

Group 3: Placebo

PLACEBO COMPARATOR

Participants will consume 400 mL/day placebo beverage containing 1,250 mg/day lactate \[200 mL placebo beverage, and 200 mL placebo beverage (prior to breakfast and dinner) for 12 weeks.

Dietary Supplement: Study Beverage Consumption

Interventions

Study Beverage Consumption DIETARY_SUPPLEMENT

All participants will follow the same intervention as the study staff is blinded in addition to the participant. Randomized participants will be asked to consume 2 bottles per day of a study beverage for 12 weeks. Compliance checks will occur remotely by having participants send photos of their bottles each day and weekly phone/video calls with intervention staff. Participants will be asked to keep their diet and activity level consistent throughout the 12 weeks.

Group 1: Vinegar; Group 2: Vinegar/Placebo Combination; Group 3: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects are overweight at screening (Visit 1, Day -14), as defined by a BMI of between 25.0 to ˂30.0 kg/m2, inclusive.
• Subjects have abdominal obesity at screening (Visit 1, Day -14), as defined by a waist circumference of \>102 cm for males or \>88 cm for females (ATP III, 2001).
• Physical examination and vital signs are normal, or deemed abnormal but clinically insignificant by the Principle and/or Medical Investigator.
• Clinical laboratory evaluations (including but not limited to clinical chemistry \[fasted at least 8 hours\], including creatine phosphokinase (CPK)\], amylase, lipid profile, thyroid stimulating hormone (TSH), free thyroxine (T4), cortisol) complete blood count (CBC), are within the reference ranges for the central laboratory, unless deemed not clinically significant by the Investigator.
• Female subjects who are postmenopausal (absence of menses for 1 year or more), women who are surgically sterilized, or women of child-bearing potential (WOCBP) who are nonlactating and have been using an effective form of birth control for a minimum of 6 months prior to screening and agree to continue using the effective form of birth control during the study and for 30 days after the treatment period \[effective forms of birth control include oral pills with a concentration of at least 50 μg of the estrogenic component of a biphasic or triphasic pill; transdermal, injectable, or implantable contraceptive; intrauterine device; or double-barrier method (e.g., diaphragm and condom). Abstinence is not considered an acceptable form of birth control.\] WOCBP who are using low dose oral birth control must also use a barrier method of contraception for the duration of the study.
• Subjects who, during the investigative period, are willing to:
• Consume the prescribed amount of vinegar beverage;
• Wear the accelerometer (Fitbit);
• Complete food intake diary as required.
• Collect stool sample
• Willing to archive blood and stool samples
• Subjects who are capable of giving informed consent and complying with all study procedures/ requirements.

You may not qualify if:

• Subjects who, in the past 6 months, have dieted or have used any supplement/medication intended to affect body weight or suppress appetite
• Subjects with a history of an eating disorder in the last 5 years.
• Subjects who have had or are planning to have bypass surgery, stomach banding surgery, or any other surgical procedure(s), including those of a cosmetic nature, that attempt to aid/promote weight loss or alter body composition.
• Subjects with Type I or Type 2 diabetes mellitus.
• Subjects with endocrine disease (thyroid dysfunction defined by serum levels of T4, TSH or a past diagnosis of Cushing syndrome).
• Subjects who have a history or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological (e.g., HIV/AIDS), dermatologic, urological, neurological, psychiatric, or cardiovascular disease or disorder.
• Subjects with any implanted electric device (such as a cardiac defibrillator) or other medical device that would allow for them to perform an MRI.
• Women with polycystic ovarian syndrome.
• Women who began taking oral contraceptives or hormone replacement therapy recently, within the last 6 months.
• Women who plan to become pregnant during the study or were pregnant or nursing within the past year.
• Subjects who have recently undergone barium tests/exams (within 7 days), or who have had a nuclear medicine scan or injection with an x-ray dye (within 3 days).
• Subjects who have a history or presence of alcoholism or drug abuse within the previous 2 years and/or a positive urine drug screen at screening.
• Subjects who have quit smoking in the last 6 months or who plan on quitting/altering smoking habits during their participation in this clinical trial.
• Subjects who donated 1 pint or more of blood or blood products within 56 days prior to the study, and/or had a plasma donation within 7 days prior to the study or who plan to donate blood or blood products during their participation in this clinical trial.
• Subjects with poor peripheral venous access that would preclude blood collection.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Mizkan Holdings Co., Ltd.: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Study Officials

• Frank J Greenway, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Shengping Yang, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be blinded as to which group they are randomized since both the vinegar and placebo beverages are the same in appearance and taste. The Investigators, clinic staff, and intervention staff are also all blinded. The only unblinded group is the Metabolic Kitchen who facilitates randomization and distribution of study product.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director Clinical Nutrition and Metabolism Lab

Model Details: VAnish is a randomized, placebo-controlled, parallel study model with 3 groups consisting of 20 participants who will all consume 2 bottles of study product per day. Group 1 will receive 400mL/day of vinegar; Group 2 will receive 200mL/day of vinegar and 200mL/day of the placebo drink; Group 3 will receive 400mL/day of the placebo drink.

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 13, 2021
• Study Start: February 10, 2021
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)