NCT02501356

Brief Summary

To compare the effects of daily intake of the ISOThrive supplement vs. a placebo on the primary outcome measure of body weight and secondary outcome measures (hunger/satiety, health-related measures and self-reported quality of life) in a group of overweight but otherwise healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

April 22, 2015

Last Update Submit

March 25, 2020

Conditions

Obesity

Keywords

prebioticdietary supplement

Outcome Measures

Primary Outcomes (1)

  • Body Weight

    Body weight will be measured at the beginning and at the end of the study using a calibrated digital scale.

    Up to 12 weeks

Secondary Outcomes (19)

  • Hunger/satiety

    Up to 12 weeks

  • Satiety indicators

    Up to 12 weeks

  • Dietary intake data

    Up to 12 weeks

  • Body mass index (BMI)

    Up to 12 weeks

  • Body composition

    Up to 12 weeks

  • +14 more secondary outcomes

Study Arms (3)

ISOThrive supplement 1

ACTIVE COMPARATOR

Participants assigned to the ISOThrive supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period.

Dietary Supplement: ISOThrive Supplement

ISOThrive supplement 2

ACTIVE COMPARATOR

Participants assigned to the ISOThrive supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period.

Dietary Supplement: ISOThrive Supplement

Placebo supplement

PLACEBO COMPARATOR

Participants assigned to the placebo supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period.

Dietary Supplement: Placebo Supplement

Interventions

ISOThrive SupplementDIETARY_SUPPLEMENT

Consumption of ISOThrive supplements for 3 months

ISOThrive supplement 1ISOThrive supplement 2
Placebo SupplementDIETARY_SUPPLEMENT

Consumption of Placebo supplement (Magnesium stearate or methylcellulose) for 3 months

Placebo supplement

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of 25 and over and weight not \> 350lb
  • Age between 18 and 75
  • Non-smokers
  • Able to read and write in English

You may not qualify if:

  • Pregnant and/or lactating women
  • Evidence or history of substance or alcohol abuse (include if over 5years)
  • History of major depression, bipolar disorder or schizophrenia, any type of obsessive-compulsive disorder
  • Current history of migraine headaches (include if controlled with medication)
  • Current use of any prescription or non-prescription weight loss products
  • Tobacco use
  • Active eating disorder including anorexia nervosa and bulimia
  • Known sensitivity or allergy to any of the ingredients in the product
  • Symptomatic coronary artery disease or congestive heart failure
  • History of a stroke in the past year
  • Symptomatic arrhythmia
  • Uncontrolled hypertension (i.e. systolic pressure \>180 mmHg and or diastolic \> 110 mmHg)
  • History of a seizure in the past 5 years
  • Any cancer in the past 5 years other than non-melanoma skin cancer or in-situ cervical cancer
  • Active or history of inflammatory bowel disease
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • David L. Katz, MD, MPH

    Yale-Griffin Prevention Research Center

    PRINCIPAL INVESTIGATOR

  • Valentine Y. Njike, MD,MPH

    Yale-Griffin Prevention Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

July 17, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

US(1)