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HealthyPhase 1NCT03152682

A Study Evaluating Good Idea on Glucose Homeostasis in a Healthy Population

A Phase 1 study testing GoodIdea in people with Healthy, run by DoubleGood AB at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A crossover design to evaluate the safety and efficacy of GoodIdea TM (trademark) on glucose homeostasis in a healthy population. Eligible participants will be given either the GoodIdea drink or placebo and a standardized meal and will consume both in approximately 15 minutes. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
GoodIdea
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteCanada
Study dates
22 Apr 2017to 15 Aug 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female 18 to 50 years of age
  • BMI 25-29.9 (±0.5) kg/m²
  • Female participant is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR
  • Females of childbearing potential who agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Double-barrier method
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  • Intrauterine devices
  • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
  • Vasectomy of partner (shown successful as per appropriate follow-up)
  • White North American (should include Hispanic, non-Hispanic, Aboriginal and Asian) or African American
  • Stable body weight defined as no more than ± 3 kg change during the last 2 months
  • Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
  • Self-perceived general good health as per the general health questionnaire
  • Fasting blood glucose < 6.1 mmol/L at screening
  • Healthy as determined by laboratory results and medical history
  • Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
  • Has given voluntary, written, informed consent to participate in the study

Who cannot join

  • Women who are pregnant, breast feeding, or planning to become pregnant during the trial
  • Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the Qualified Investigator
  • Has undergone procedures that requires cleansing of the bowel, such as colonoscopy or barium enema within three months prior to randomization
  • Type I or Type II diabetes
  • Use of over-the-counter medication or natural health products that affect glucose metabolism is prohibited within 2 weeks of enrollment and during this study
  • Use of anti-biotics within 2 weeks of enrollment
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  • Use of probiotic supplements within 2 weeks of enrollment
  • Use of cholesterol lowering medications
  • Use of blood pressure medications
  • Use of over-the-counter decongestants that contain ephedrine or pseudoephedrine within 2 weeks of enrollment
  • Use of acute or over the counter medications within 72 h of test product consumption
  • Use of Tricyclic antidepressants or any other medication that will modify bowel function
  • Metabolic diseases and chronic gastrointestinal diseases (IBS, Crohns etc.)
  • Allergy to test product or placebo ingredients
  • Participants restricted to a vegetarian or vegan diet
  • Intolerance to lactose or gluten
  • Irregular dietary habits, including: intermittent fasting, regularly skipped meals, and individuals who do not typically eat breakfast
  • Any form of acute infection within 2 weeks of enrollment
  • Individuals who are immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis)
  • History of gastrointestinal dysfunction or surgery that may influence digestion or absorption
  • History of blood/bleeding disorders
  • Individuals who are averse to venous catheterization or capillary blood sampling
  • Current diagnosis of cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
  • Individuals who have planned surgery during the course of the study
  • Alcohol or drug abuse within the last 6 months
  • Currently active smokers (tobacco products, and e-cigarettes) or smoking within the 6 months of enrollment
  • Blood or plasma donation in the past 2 months
  • Participants planning to donate blood during, or within 30 days following completion of the study
  • Use of medical marijuana
  • History of, or current, psychiatric disease
  • Unstable medical conditions as determined by Qualified Investigator
  • Clinically significant abnormal laboratory results at screening
  • Participation in a clinical research trial within 30 days prior to randomization
  • Individuals who are cognitively impaired and/or who are unable to give informed consent
  • Any other condition which in the Qualified Investigator's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
  • Medical or psychological condition that in the Qualified Investigator's opinion could interfere with study participation

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • KGK Synergize Inc.

    London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: A Multi-centre Randomized, Double-blind, Placebo-controlled, Crossover, Proof-of-concept Study to Evaluate the Efficacy and Safety of Good IdeaTM on Glucose Homeostasis in a Healthy Population

A crossover design to evaluate the safety and efficacy of GoodIdea TM (trademark) on glucose homeostasis in a healthy population. Eligible participants will be given either the GoodIdea drink or placebo and a standardized meal and will consume both in approximately 15 minutes. Blood will be drawn at several time points over a 3 hour period to determine the study objectives. After a 7-day washout, the participants will come back to the clinic and and complete the visit consuming the opposite product given at the previous visit. The primary objective is to see the difference of the two-hour iAUC for intravenous blood glucose between the active product (GoodIdea) and the placebo following a standardized meal.

Conditions
Healthy
Being tested
GoodIdea, Placebo
Keywords
glucose, glucose homeostasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GoodIdeaDietary supplement

    Active product. Amount: 355mL. Consumed at a clinic visit over 14 minutes.

  • PlaceboOther

    Non-active placebo product. Amount: 355mL. Consumed at a clinic visit over 14 minutes.

Study groups in NCT03152682
Study groupRoleWhat they receive
Consume GoodIdea at Visit 2 and Placebo at Visit 3ExperimentalNot described
Receives: Dietary Supplement: GoodIdea; Other: Placebo
Consume Placebo at Visit 2 and GoodIdea at Visit 3ExperimentalNot described
Receives: Dietary Supplement: GoodIdea; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference of the two-hour iAUC (0 - 120 min) for intravenous blood glucose between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 120 minutes

Secondary outcomes (13)

  1. The difference of the two-hour iAUC (0 - 120 min) for capillary blood glucose between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 -120 minutes

  2. The difference in the two-hour Cmax, (0 - 120 min) of capillary glucose between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 120 minutes

  3. The difference in the two-hour Tmax (0 - 120 min) of capillary glucose between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 120 minutes

  4. The difference in the two-hour iAUC (0 - 120 min) intravenous insulin iAUC between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 120 minutes

  5. The difference in the two-hour Cmax (0 - 120 min) of intravenous glucose and insulin between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 120 minutes

  6. The difference in the two-hour Tmax (0 - 120 min) of intravenous glucose and insulin between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 120 minutes

  7. The difference in the three-hour iAUC (0 - 180 min) for intravenous blood glucose and insulin between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 180 minutes

  8. The difference in the three-hour Cmax (0 - 180 min) of intravenous glucose and insulin between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 180 minutes

  9. The difference in the three-hour Tmax (0 - 180 min) of intravenous glucose and insulin between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 180 minutes

  10. The difference in the three-hour iAUC (0 - 180 min) of capillary glucose between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 180 minutes

  11. The difference in the three-hour (0 - 180 min) Tmax of capillary glucose between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 180 minutes

  12. The difference in the three-hour (0 - 180 min) Cmax, of capillary glucose between Good IdeaTM and the placebo following a standardized meal.

    Measured: 0 - 180 minutes

  13. Eating patterns as assessed by a 3-day food record for the weeks prior to days 0 and 8.

    Measured: 1 week each

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017
  2. Study start22 Apr 2017
  3. Primary completion15 Aug 2017
  4. Study completion15 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03152682
Sponsor's protocol ID
17GGHD
Status last verified
Nov 2022
First submitted
9 May 2017
Last updated
22 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ostman E, Samigullin A, Heyman-Linden L, Andersson K, Bjorck I, Oste R, Humpert PM. A novel nutritional supplement containing amino acids and chromium decreases postprandial glucose response in a randomized, double-blind, placebo-controlled study. PLoS One. 2020 Jun 24;15(6):e0234237. doi: 10.1371/journal.pone.0234237. eCollection 2020.

    PubMed 32579549

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GoodIdea in people with Healthy, run by DoubleGood AB at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference of the two-hour iAUC (0 - 120 min) for intravenous blood glucose between Good IdeaTM and the placebo following a standardized meal. (time frame: 0 - 120 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03152682, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.

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Clinical Trial NCT03152682 | AzTrials