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

NCT03152682 | Completed Phase 1

• 1 other identifier: 17GGHD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

glucose; glucose homeostasis

Outcome Measures

Primary Outcomes (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.

  0 - 120 minutes

Secondary Outcomes (13)

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

  0 -120 minutes

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

  0 - 120 minutes

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

  0 - 120 minutes

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

  0 - 120 minutes

• 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.

  0 - 120 minutes

Other Outcomes (5)

• The effects of supplementation with Good IdeaTM on vital signs (blood pressure) compared to placebo

  180 minutes

• The effects of supplementation with Good IdeaTM on vital signs (heart rate) compared to placebo

  180 minutes

• The change in Hematology from screening to end-of-study between Good IdeaTM and the placebo

  21 - 42 days

Study Arms (2)

Consume GoodIdea at Visit 2 and Placebo at Visit 3

EXPERIMENTAL

Dietary Supplement: GoodIdea; Other: Placebo

Consume Placebo at Visit 2 and GoodIdea at Visit 3

EXPERIMENTAL

Dietary Supplement: GoodIdea; Other: Placebo

Interventions

GoodIdea DIETARY_SUPPLEMENT

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

Consume GoodIdea at Visit 2 and Placebo at Visit 3; Consume Placebo at Visit 2 and GoodIdea at Visit 3

Placebo OTHER

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

Consume GoodIdea at Visit 2 and Placebo at Visit 3; Consume Placebo at Visit 2 and GoodIdea at Visit 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• DoubleGood AB: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 32579549 RESULT

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 15, 2017
• Study Start: April 22, 2017
• Primary Completion: August 15, 2017
• Study Completion: August 15, 2017
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)